Head of Material Planning
Northborough, MA job
**Job Title:** Head of Material Planning **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
The Supply Chain organization is responsible for all supply chain activities across the Massachusetts BioCampus.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
**Main Responsibilities:**
**PCU Material Planner Team Member responsibilities are:**
+ Makes sure the 3rd party materials are planned with the right coverage targets as defined by Policy or Critical Material Manager (GSP) in case of exceptions / deviations - Reporting of deviations to coverage targets to Critical Material Manager (GSP)
+ Reviews SAP requisitions or Site Scheduler requests for Purchase Requisitions
+ Converts Purchase Requisitions sent by Site Scheduler into Purchase Orders, considering factors such as current inventory levels, safety stock policies, material coverage, , and supplier agreements.
+ Sends Purchase Orders/Schedule lines to suppliers, respecting suppliers' Lead Time, and updates supplier confirmation for each Purchase Order (order acknowledge) in the system so reception dates are available for the site logistic operations in the system if EDI is not established. In case EDI is in place the Material Planner checks the confirmed date and gets in contact with the scheduler or planner if the confirmed delivery date shows a discrepancy of more than +/-10 days
+ Assesses the availability of materials.
+ Collaborate with the quality team to secure the release on-time for third party purchasing materials and thereflection of this time in the ERP system to ensure master data correctness
+ Manages material issues with Site Planner or Scheduler, depending on the horizon of the issue.
+ Connects with suppliers to monitor the status of the supply plan and to detect exceptions to it as soon as possible to be able to address them.
+ Coordinates with Critical 3rd Party Material Planner (GSP) if any risk of material shortage cannot be addressed at the site level.
+ Support warehouse and/or quality teams in complaint management and related deviations
+ Communicates monthly rolling forecast to up to 36 months, confirming suppliers' capacity in collaboration with Site Scheduler and Supply Planner.
+ Provides Forecasts, OTIF data, etc. To Critical 3rd Party Material Planner (GSP) for Supplier S&OPs or Global Supply Review
+ Ensures system is updated (in terms of supplier feedback to requested supply) for Critical 3rd Party Material Planner (GSP) to be able to get the mid to long-term forecast from the system.
+ Ensures purchased materials are delivered in time for testing release and use.
+ Monitor issues regarding shipping and returns.
+ Track supplies' performance metrics.
+ Initiate conversation with suppliers and Critical 3rd Party Material Planner (GSP) in case of deviation from expected performance.
+ Communicate the need for qualifying new suppliers to procurement in case of materials shortages from existing suppliers.
+ Support the quality related topic for 3rd party materials, including creation and monitoring of change control request (CCR) related to supplier changes/ supplier notifications, new products, etc.- Analyzes and proposes updates to Master Data to enhance industrial performance.
+ Ensures critical (leadtime > frozen horizon) or high value (ABC > 80% of value) material is flagged as KX relevant and MRP is done in KX unless exception conditions met (VMI in SAP, Quota management in SAP, etc.) and creates BuyBODs
**The PCU meeting roles of the PCU Material Planner Team Member are:**
+ Leads the MRP Meeting
+ Contributes to the Level 1 Supply Chain +QDCI meeting
+ Contributes to the Handover to Scheduler meeting
+ Contributes to the Transparency meeting
+ Contributes to Capability Review in case of capacity limiting Material Constraint
**CI loop contribution of PCU Material Planner Team Member includes:**
+ Collaborating with data steward and suppliers to maintain MRP Data in systems (MOQ, Lead Times, Safety Stocks, etc.).
+ As DCO, analyzing and preparing proposal of Master Data Evolution to support the industrial performance.
**Takes responsibility for the availability of components to enable production orders.**
+ Tracks suppliers OTIF and performs root cause analysis for planning changes and action plan follow-up.
+ Manages performance of Suppliers (OTIF) linked with KSOL. Manages Critical Material (materials at risk and critical suppliers)
**Key Involvement in Decision-Making Process**
**Key Roles (D,A,I)**
+ A/I: Prepares key insights for Supplier S&OPs, key advisor to identify critical
+ materials in alignment with Critical Material Manager GSP
+ A/I: Key advisor in CI initiatives related to material planning,
+ D: Takes care of implementation of CI initiatives
+ A/I: Strongly involved in setting thresholds for 3rd party Material in system (e.g., high stock values, long lead times, VMI)
**About You**
**Basic Qualifications**
+ Bachelor's Degree
+ 10+ years of materials, purchasing or supply chain experience
+ 5+ years of supervisory experience
+ 5+ years of experience working with SAP and inventory management systems
+ Excellent communication skills
+ Proficient with MS office applications
**Preferred Qualifications**
+ Bachelor's Degree in a science or technical field
+ Experience in pharmaceuticals or a related industry
+ APICS Certification and 10+ years' experience using SAP, and Oracle strongly desired
+ Strong understanding of planning and purchasing systems in a CGMP manufacturing environment
+ Project management skills
+ Expertise in document management systems
+ Knowledge and understanding of biopharmaceutical CGMP manufacturing preferably in large scale commercial biologics manufacturing required.
+ Solid understanding of quality, supply chain, finance and planning
+ Knowledgeable of requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions
+ Knowledge and experience with discrepancy investigation and lot disposition.
**Disclaimer**
The above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship.
**Why Choose Us**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
\#GD-SG
\#LI-GZ
\#LI-Onsite
\#vhd
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ !
_US and Puerto Rico Residents Only_
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
_North America Applicants Only_
The salary range for this position is:
$114,750.00 - $165,750.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* .
Global Terms & Conditions and Data Privacy Statement (***************************************************************
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (*****************************
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************
Biostatistics Evidence Generation & Decision Sciences (EGDS)- Summer 2026 Intern
Cambridge, MA job
About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
Join our B&P Neurology team as a Data Analyst and you'll lead one or several late phase studies, or lead an indication for a complex compound, under supervision of statistical project leader and/or team leader.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
* Contribute to the design and analysis of both early- and late-phase clinical trials by applying advanced statistical methods and data analysis techniques.
* Support the development, evaluation, and implementation of innovative statistical methodologies to address complex problems in clinical research.
* Work collaboratively under the guidance and mentorship of senior-level statisticians, gaining hands-on experience in study planning, data interpretation, and the preparation of statistical reports and publications.
About You
Basic Qualifications:
* Currently enrolled and pursuing PhD in Statistics or Biostatistics at an accredited college or university
* Candidates must have completed at least two years of graduate coursework and be working on a dissertation toward a PhD in Statistics or Biostatistics
* Experience with SAS and R
* Must be able to relocate to the office location and work 40hrs/week, Monday-Friday, for the full duration of the co-op/internship
* Must be permanently authorized to work in the U.S. and not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship
Preferred Qualifications:
* Effective oral and written communication skills
* Experience with python is a plus
Why Choose Us?
* Bring the miracles of science to life alongside a supportive, future-focused team.
* Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
* Exposure to cutting-edge technologies and research methodologies
* Networking opportunities within Sanofi and the broader biotech community.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SA
#LI-SA
#LI-Onsite
#vhd
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Auto-ApplyPlanning and Scheduling Specialist
Framingham, MA job
**Job Title:** Planning and Scheduling Specialist **About the Job** Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.
This organization is responsible for providing Facilities, Engineering and Maintenance support for all cGMP process and utility systems at Framingham MA Campus, maintaining these systems in a validated state of control and ensuring uninterrupted business continuity. This organization is also responsible for shared GMP and non GMP systems on the Framingham campus as defined by Service Level Agreements and this role will support key campus stakeholders including but not limited to Research & Development, Science, Global Manufacturing Sciences and Technology. This organization is also responsible for non GMP maintenance of buildings on the Framingham campus in conjunction with North America Sanofi Business services (SBS) and is the main group interfacing with SBS.
Takes a lead role in matters related to asset management, PM program and planning and scheduling of preventive and unscheduled maintenance activities. Contributes to continuous improvement projects and initiatives.
**About Sanofi:**
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
**Main Responsibilities:**
+ Maintains the Computerized Maintenance Management System (CMMS) to plan and schedule work orders, preventive maintenance activities, material lists and asset management.
+ Receives all work orders from requesting departments and end-users. Assess work request and makes decisions regarding response time and level of planning activities based on priority of requested work.
+ Adapts to changing production needs and prioritizes work among conflicting schedules and expectations.
+ Develops maintenance work packages by evaluating work orders for required permits, action notices, job steps, spare parts, tools, labor and opportunities for efficiencies.
+ Ensures estimate for time required to perform work activities are accurate for the purpose of establishing a schedule.
+ Utilizes reports to optimize schedule and level loading of resources.
+ Works in a collaborative team environment and interacts with other departments such as Engineering, Facilities, Validation, Quality, Manufacturing, and Metrology.
+ Team member or lead for special projects as assigned.
+ Acts as subject matter expert for work order management, asset management and PM program.
+ Supports audit requests and CMMS training.
+ Meets with production and area owners to finalize equipment availability and schedule upcoming maintenance activities.
+ Utilizes maintenance reports/metrics to manage incoming and future work activities.
+ Acts as Shutdown Coordinator or participates in the coordination and scheduling of building and utility shutdowns.
**About You**
**Basic Qualifications**
+ High School Diploma with 3+ years planning or scheduling or related work experience.
+ Strong organizational, administrative, and analytical skills.
+ Working knowledge of Computerized Maintenance Management System (CMMS), Computerized Calibration Management System (CCMS)
+ Experience working within cross-functional teams.
+ Working knowledge of quality management systems.
+ Customer service oriented, works well with internal and external customers.
**Preferred Qualifications**
+ Experience working for a maintenance organization in a cGMP Biotech/Pharmaceutical manufacturing environment.
+ Knowledge of methods, materials, tools and equipment used in the maintenance of a modern pharmaceutical facility.
+ Knowledge of industrial and manufacturing equipment with the ability to help coordinate building shutdowns.
+ Ability to identify potential safety hazards, LOTO requirements, and appropriate precautions applicable to work assignments.
+ Experience in a Enterprise Asset Management System.
**Special Working Conditions**
+ Ability to gown and enter clean rooms.
**Why Choose Us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
\#GD-SG
\#LI-GZ
\#LI-Onsite
\#vhd
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ !
_US and Puerto Rico Residents Only_
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
_North America Applicants Only_
The salary range for this position is:
$35.56 - $47.41
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* .
Global Terms & Conditions and Data Privacy Statement (***************************************************************
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (*****************************
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************
Global Regulatory Affairs CMC Lead
Framingham, MA job
Job Title: Global Regulatory Affairs CMC lead About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
As GRA CMC Lead within our GRA CMC & GRA Device Organization, you'll drive global regulatory strategies for pharmaceutical and vaccine products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of drug approvals through strategic negotiations with health authorities worldwide.
Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the opportunity to drive regulatory strategy for pharmaceutical products and vaccines across their lifecycle. Working at the intersection of science and compliance, you'll develop CMC strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities including FDA and EMA. You'll collaborate across R&D, Manufacturing, and Quality teams while preparing high-quality regulatory submissions, managing compliance, and anticipating regulatory trends-all contributing directly to bringing innovative therapies to patients worldwide
About Sanofi
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on Chemistry, Manufacturing, and Controls (CMC) and medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team develops and implements global regulatory strategies for pharmaceutical products, biologics, vaccines, and combination products, working closely with cross-functional partners to navigate complex regulatory landscapes. With a commitment to Sanofi's "Take the Lead" values, particularly in "Leading Together" and "Being Bold," our mission is to secure timely approvals while maintaining the highest standards of quality and compliance, ultimately supporting Sanofi's goal of bringing innovative healthcare solutions to patients worldwide.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
Develop and implement global regulatory CMC strategies
* Create strategies for development and marketed products
* Focus on chemical entities, biological entities, and/or vaccine products
* Execute and adapt strategies as needed
Serve as the primary point of contact for regulatory authorities
* Act as direct liaison with agencies like US FDA and EMA
* Develop positive relationships with regulators
* Support strategic negotiations with worldwide Regulatory Health Authorities
Manage CMC documentation and submissions
* Write, prepare, review, and approve regulatory CMC dossiers
* Ensure dossiers meet quality standards
* Comply with regulatory requirements
* Maintain documentation accuracy and completeness
Lead cross-functional collaboration
* Work closely with R&D Functions
* Collaborate with Manufacturing & Supply Functions
* Coordinate with GRA Regulatory Operations
* Ensure effective implementation of regulatory strategies
* Facilitate resolution of CMC issues
Identify and manage regulatory risks
* Assess regulatory CMC opportunities and risks
* Develop risk mitigation strategies
* Communicate implications to project teams
* Articulate risk/benefit components to stakeholders
Contribute to regulatory science and policy activities
* Monitor local and international Health Authority regulations and guidelines
* Participate in the review process for new regulations
* Anticipate potential regulatory paradigm shifts
* Track and communicate current Health Authority thinking and trends
About You
* Experience: 4+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.
* Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes
* Technical Knowledge: Understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets.
* Collaboration Skills: Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams.
* Education: Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field).
* Communication: Strong written and verbal communication skills, with fluency in English.
* Adaptability: Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth.
Why Choose Us?
* Bring the miracles of science to life alongside a supportive, future-focused team.
* Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
* Play a crucial role in bringing innovative therapies to millions worldwide, working at the forefront of drug discovery and development with a patient-centric approach.
* Leverage advanced AI, data, and digital platforms to push the boundaries of pharmaceutical science and regulatory strategy.
* Engage with diverse teams spanning scientific, clinical, and digital fields, fostering breakthroughs through cross-functional collaboration.
* Benefit from structured career paths offering both scientific and leadership advancement opportunities, including bold moves and short-term projects to expand your expertise.
* Join a workplace that prioritizes diversity, equity, and inclusion, with programs that celebrate every voice and perspective.
* Enjoy a supportive R&D environment that values work-life balance, offering flexible working options (60% on-site) and comprehensive well-being programs.
* Influence global regulatory strategies, interact with key health authorities, and stay at the forefront of evolving industry trends and regulations.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SA
#LI-SA
#LI-Onsite
#vhd
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$122,250.00 - $176,583.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
Auto-ApplyDirector - Neuroscience
Boston, MA job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
We are seeking a highly motivated scientific laboratory leader with a solid background in Neuroscience to join our growing Psychiatry, Pain and Neuronal Health Team within Neuroscience Discovery Group at Lilly's Indianapolis Lilly Research Laboratories site. The ideal candidate will be a critical thinker with a deep understanding of Neuroscience and neuronal plasticity, with an emphasis on psychiatric and neurodevelopmental disorders. Successful candidates will have demonstrated abilities to lead a laboratory in industry and/or biotech that provides critical and robust decisional data. Demonstrated ability to develop preclinical in vivo biomarker assays, such as EEG, for translational early clinical phase development is desirable. The candidate will be an integral part of multiple cross-functional teams focused on developing novel medicines across broad neurological and psychiatric disorders. There is an expectation of effective communication skills and the ability to work collaboratively across the multiple geographies of Lilly's research sites, and strong leadership of cross-functional teams.
Overall Responsibilities:
* Supervise a group of dedicated laboratory neuroscientists.
* Lead cross-functional teams in preclinical drug development phase.
* Present data and conclusions to leadership and decision makers in a clear, balanced, and compelling manner.
* Identify, develop, and implement innovative approaches to add functional capabilities and gain new insights into psychiatric and neurological disease biology, target engagement and pharmacodynamics.
Basic Qualifications:
* PhD in Biology, Biochemistry Neuroscience, Neurophysiology, or related scientific discipline with 10+ years industry or academic experience beyond any postdoctoral positions.
* Alternatively, a Masters degree in Neuroscience, Neurophysiology, or related scientific discipline with 20+ years industry or academic work experience leading a laboratory and leading discovery projects through preclinical development
Additional Skills/Preferences:
* Clear understanding of pharmacology principles and measures of target engagement ex vivo or in vivo to drive human dose projections.
* Demonstrated ability to lead a cross-functional team and translate preclinical biomarkers to clinical development.
* Experience preparing document for regulatory filings.
* Excellent communication and presentation of scientific skills.
* Ability to work both independently and in cross-functional teams, as well as influencing beyond direct reports.
* Demonstrated expertise in Neuroscience research as evidenced by peer reviewed publication record.
Additional Information:
* 20-30% travel
* On Site position at Lilly Coporate Center in Indianapolis, Indiana and/or Lilly Seaport Innovation Center in Boston, Massachusetts
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$144,000 - $250,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyScientist - Mass Spectrometry
Boston, MA job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The LIGM RNA Group is seeking an experienced analytical scientist with extensive hands-on experience in analytical techniques for characterizing and analyzing small molecules, biologics, and/or oligonucleotides. The ideal candidate will have a proven track record in analytical method development and troubleshooting, as well as experience with liquid chromatography, (high resolution) mass spectrometry, and other advanced analytical techniques.
They must possess strong technical problem-solving skills, be computer savvy with the ability to navigate multiple instrument control programs and data analysis environments, and be able to work independently to achieve efficient, quality results in a fast-paced environment.
Responsibilities:
* Work closely with the chemistry team to source, explore, and implement the latest separation science and analytical technologies for the purification and characterization of oligonucleotides and their conjugates, including carbohydrates, lipids, peptides, and proteins.
* Conduct LC and LC-MS based method development for sensitive characterization of biologics including intact mass, reduced mass, peptide mapping, and glycan mapping to provide better understanding of attributes.
* Conduct semi-preparative and preparative method development activities to advance downstream processing for challenging modified oligonucleotides, utilizing RP purification, ion-exchange chromatography, spin filtration, TFF, FPLC, size exclusion chromatography, and MS-direct auto-scale preparative LC-MS techniques.
* Work with contractors and third-party vendors to troubleshoot and maintain lab instruments, including but not limited to UPLC, LC-MS, osmometer, and NanoDrop, ensuring they remain in peak operational condition.
* Learn new technologies quickly and apply effective scientific concepts and methods across multiple areas.
* Process and present data leveraging Microsoft Office apps, GraphPad and Spotfire for data organization and data visualization.
* Document experiments, data, technical reports, and findings electronically in an accessible manner with good documentation practices.
* Present findings, progress, and data proactively and regularly in group and department meetings.
* Possess a collaborative and willing-to-share mindset with excellent verbal and written communication skills, presentation skills, and attention to detail.
* Ability to follow Global Health, Safety & Environment Center (HSE) guidelines while performing tasks.
Basic Qualifications:
Bachelor's or Master's degree in Analytical Chemistry, Biochemistry, Chemistry, Food Science, or a related scientific field, with over 2 years of relevant post-graduate experience in industry.
Additional Skills/Preferences:
* Strong analytical thinking skills with a demonstrated ability to articulate issues and extract and synthesize complex information into key focus areas.
* Extensive experience in operating and troubleshooting a range of mass spectrometers including Q-ToF, QQQ and Orbitrap
* Proficient with Thermo XCalibur, Agilent ChemStation and MassHunter software.
* Understanding tandem mass spectrometry and interpretation of MS/MS based characterization of including but not limited to peptide, peptide-oligonucleotide conjugates, and lipid conjugates.
* Extensive hands-on experience in downstream workflows for small molecules, biologics, and oligonucleotides. Experience with antibody-drug-conjugates (ADCs) or antibody-oligonucleotide-conjugates (AOCs) is a plus.
* Proven expertise in liquid chromatography including ion-pair reverse phase liquid chromatography as well as ion chromatography.
* Prior experience in native mass spectrometry and understanding of electrospray ionization as well as molecular behavior in the gas phase.
* Prior experience in proteomics, bioanalysis, and/or CMC is a significant advantage.
* Highly self-motivated and self-driven attitude with ability to own and drive projects into success.
* Strong organizational and communication skills and effective people skills.
* Capable of continuous learning, open-minded, highly organized, and detail oriented.
* Ability to balance multiple activities, prioritize and handle ambiguity.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$71,250 - $187,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplySpecialist, Lead Clinical Manufacturing Associate, Cell Therapy in Devens, MA
Devens, MA job
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
BMS Cell Therapy Manufacturing is seeking a Specialist, Lead Clinical Manufacturing Associate, Cell Therapy that bring enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. We are searching for enthusiastic, and innovative individuals with a good understanding of good manufacturing practices to support start up activities, and routine manufacturing operations for Cell Therapy. This role is key to start up of Clinical Trials at Devens in a multi-product Cell Therapy Facility.
Shifts Available:
TBD
Responsibilities:
* Execute operations described in standard operating procedures and batch records.
* Demonstrates strong practical and theoretical knowledge in their work
* Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
* Solves complex problems; takes new perspectives using existing solutions
* Performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
* Completing training assignments to ensure the necessary technical skills and knowledge.
* Sets up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.
* Collaborates with support groups on recommendations and solving technical problems.
* Help to ensure the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule.
* Collaborates closely with Shift Managers to ensure seamless pass down and communication of operational status.
* Supports investigations
* Identifies innovative solutions
* Supports writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
* Training others on SOPs, Work Instructions to successfully complete manufacturing operations.
* Working with production planning with leadership to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts.
* Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
Knowledge, Skills, Abilities:
* Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
* Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays).
* Must be able to work in a cleanroom environment and perform aseptic processing
* Must be comfortable being exposed to human blood components.
* Must be able to be in close proximity to strong magnets.
Preferred Qualifications:
* Experience in cell therapy manufacturing, including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment.
* Experience in the following preferred: Aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas.
* Cell expansion using incubators and single use bioreactors.
Basic Requirements:
* 4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience
* Bachelors in relevant science or engineering discipline, or equivalent in work experience.
Physical Demands:
* Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time, throughout the day.
* Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.
* Climb - Required to climb (use of stepladders in production areas, or stairwells) several times a day.
* Bend and Kneel - Required to bend or kneel several times a day.
* Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day.
* Moving Head and Neck - Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day.
* Twisting - Required movement of twisting waist while setting up equipment several times a day, throughout the day.
* Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day.
* Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.
BMSCART
#LI-ONSITE
GPS_2025
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
Devens - MA - US: $91,190 - $110,498
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit *************************************
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: *********************************************
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Auto-ApplyComputational Infrastructure Scientist - Biological Data Systems
Boston, MA job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
We are seeking a Computational Infrastructure Scientist to help build and extend the data systems that power large-scale biological and genetic research - the foundations of modern biology and precision medicine.
This is a scientific engineering position, ideal for a PhD-level scientist who bridges biology, computation, and informatics. The successful candidate will have a deep understanding of the complexity and diversity of biological and genetic data, and a passion for designing robust, reusable infrastructure that makes this data usable, reproducible, and scalable across research and discovery pipelines.
You will work at the intersection of genetics, bioinformatics, data architecture, and software engineering, designing systems that transform how biological and clinical-genomic information is prepared, integrated, and explored. Your work will involve:
* Developing and extending data models and ontologies that harmonize heterogeneous sources of biological, genetic, and clinical information.
* Designing scalable data ingestion, standardization, and transformation pipelines for genomic and functional datasets.
* Collaborating with domain experts in genomic medicine, computational biology, bioinformatics, genetics, and informatics to ensure that infrastructure design supports high-impact scientific use cases.
* Support and develop scientific workflows that impact the drug discovery portfolio
* Building the frameworks that enable semantic interoperability, metadata-rich data exchange, and traceable, reproducible data workflows.
* Contributing to the evolution of open data standards and knowledge representation across the life sciences.
* The ideal candidate combines scientific curiosity with engineering discipline - someone who finds beauty in well-designed systems and efficiency in well-structured data.
Responsibilities
* Strategize and implement scientific data processing workflows that transform complex biological datasets into actionable insights.
* Design and develop innovative algorithms and ETL systems to address emerging challenges in biological and drug discovery data integration.
* Collaborate cross-functionally with domain scientists and engineers to translate biological questions into computational frameworks.
* Contribute to the long-term architecture and evolution of the data platform, ensuring scalability, transparency, and reproducibility.
* Develop cloud-based workflows and APIs that enable efficient access and analysis across diverse biological datasets.
* Document and share design decisions to promote reuse and institutional knowledge.
Basic Qualifications:
* PhD in Computational Biology, Chemistry, Bioinformatics, or a related scientific field.
Additional Skills/Preferences:
* Strong programming experience in Python and strong familiarity with R.
* Experience working in Linux environments.
* Knowledge of biological databases, ontologies, and metadata systems.
* Knowledge in PostgreSQL databases
* Proficiency in Linux environments and Git (required).
* Exposure to cloud platforms (e.g., AWS S3, EC2, or equivalent).
* Experience working with workflow execution environments including NextFlow
* Experience developing data-driven decision support applications including data and visual analytical tools
* Exposure to Docker or containerized environments.
* Strong communication skills and the ability to work independently on open-ended technical problems.
* Understanding of web design and API is a plus.
What We Offer
* A unique opportunity to shape the data infrastructure that underpins next-generation biological research.
* Cross-functional exposure with state-of-the-art discovery
* A role combining scientific insight with engineering autonomy.
* Hands-on experience with cloud computing and modern data architecture.
* A collaborative environment focused on rigor, transparency, and impact.
* The chance to become a core steward of a critical research platform and its long-term sustainability.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $244,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyDirector/Senior Director, CMC, Drug Product Development
Boston, MA job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Job Summary
The Director/Senior Director, CMC, Drug Product Development will lead formulation development activities across multiple dosage forms and therapeutic modalities, with a focus on developing and incorporating digital solutions and tools into drug product workflows. The ideal candidate will bring expertise in both parenteral and solid oral dosage forms, combined with emerging capabilities in computational and AI-driven formulation approaches. Success in this role requires cross-function collaboration and leadership as well as a strategic vision for how technology can be leveraged to transform traditional drug development activities.
Key Responsibilities
Formulation Development
* Lead formulation design, development and external manufacturing for both parenteral (IV, SC, IM) and solid oral (tablets, capsules) drug products across diverse therapeutic programs and modalities
* Develop robust formulation strategies that address in vivo performance, stability, bioavailability, manufacturability, and patient-centric considerations
* Manage a network of external providers (CROs, CDMOs) with capabilities in drug product development and manufacturing
* Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and manufacturing
* Support regulatory interactions and respond to health authority questions
* Ensure compliance with cGMP standards and ICH guidelines
Digital Solution Development
* Lead the development, testing and implementation of digital solutions related to drug product development
* Partner with IT and other internal drug product subject matter experts to translate drug product workflows into requirements that can be incorporated into technology solutions
* Lead the evaluation of in silico modeling tools and AI/ML platforms that predict formulation performance and accelerate development timelines
* Continuously monitor the industry trends, competitive landscape and emerging technologies to identify future tools and technology platforms of interest
Minimum Requirements
* Education: PhD in Pharmaceutical Science or related field (Chemistry, Chemical Engineering, Pharmacy)
* 8+ years of pharmaceutical industry experience
* 3+ years of prior experience with application of in silico tools or AI/ML solutions in drug product development
Additional Skills/Preferences
* Experience working with multiple therapeutic modalities (small molecules, biologics, peptides, oligonucleotides)
* Experience with both parenteral and solid oral formulations
* Knowledge of emerging modalities including cell & gene therapy, RNA-based medicines
* Strong analytical and problem-solving skills
* Experience working with biotechs/emerging companies and/or early-stage development programs where speed to clinic is a critical success factor
* Demonstrated ability to operate effectively in fast-paced environments where rapid decision-making and pragmatic problem-solving are essential to maintain program momentum
* Track record of supporting multiple concurrent programs with varying levels of technical maturity, demonstrating agility in shifting priorities and creative approaches to address emerging challenges
Additional Information
* Remote options may be considered based on business needs
* Travel up to 10%
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$148,500 - $257,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-Apply2026 U.S Summer Internship Program: Statistics and Quantitative Sciences Intern
Boston, MA job
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
Our Data and Quantitative Sciences (DQS) is made up of more than 250 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from statistics, programming, outcomes research and epidemiology, quantitative clinical pharmacology, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and re-imagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation.
As part of DQS, the Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistics function, exceptional leaders and innovators. SQS aspires to bring safe and effective medications to the patients with our quantitative skills. We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence.
**How You Will Contribute:**
As an Intern, you will have the opportunity to
+ Conduct literature reviews and contribute to the prediction model development using various statistical methodologies.
+ Perform data analysis using SAS, R or python.
+ Support internal activities like team meetings in preparation of key program activities.
+ Use of AI enabled tools for efficiency in documents process.
+ Communicate findings and results effectively with cross-functional teams through written reports and oral presentations.
**Internship Development Opportunities:**
+ Gain hands-on experience in applying statistical methodologies to drug development and clinical trial analyses
+ Develop an understanding of regulatory and compliance standards, including how regulatory guidelines influence statistical analyses in clinical trials.
+ Strengthen project and time management by contributing projects with defined timelines, deliverables and cross-functional collaborations.
+ Learn to apply machine-learning and predictive modeling techniques to support future study design and planning.
+ Enhance ability to communicate and justify statistical approaches when addressing questions from cross-functionals.
**Job Requirements:**
+ This position will be Hybrid and require 2-3 days in the Cambridge office per week.
+ Must be pursuing a PhD in Biostatistics.
+ Strong understanding of machine learning concepts and their applications.
+ Experience in applying machine-learning methods to predict treatment outcome. based on baseline characteristics and selected post baseline biomarkers.
+ Familiarity with statistical techniques of model development and parameter tuning.
+ Proficiency in SAS and R programming languages for data manipulation and statistical analysis. Python experience is a plus.
**Internship Eligibility**
+ Mustbe authorized towork in the U.S. on a permanent basis without requiring sponsorship
+ Must be currently enrolled in a degree program graduating December 2026or later
+ The internship program is 10-12 weeksdepending on the two start dates (May 26th-August 14thor June 15th- August 21st)
+ The intern must be able to commit to one of thesetime frames
+ Able to work full time40 hoursa week during internship dates
+ Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program
**Program Highlights:**
+ Hands-on experience with real projects and responsibilities
+ Dedicated mentorship program pairing interns with experienced professionals
+ Networking opportunities with industry professionals and fellow interns
+ Internship events focused on professional and skills development
+ Exposure to multiple business areas or departments within a Pharmaceutical Organization
Applications will be accepted between November 20th-January 2nd
**Takeda Compensation and Benefits** **Summary**
We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
Boston, MA
**U.S. Hourly Wage Range:**
$21.00 - $46.00
The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. internship benefits vary by location and may include:
+ Paid sick time
+ Civic Duty paid time off
+ Participation at company volunteer events
+ Participation at company sponsored special events
+ Access to on-site fitness center (where available)
+ Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
Boston, MA
**Worker Type**
Employee
**Worker Sub-Type**
Paid Intern (Fixed Term) (Trainee)
**Time Type**
Full time
**Job Exempt**
No
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Head of Research Quality
Boston, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Objective / Purpose:
The Head of Research Quality holds the highest leadership role within the Research Quality organization and serves as a key member of the R&D Quality leadership team. This executive is fully accountable for defining and executing the global strategic vision for Research Quality, overseeing a global team of experienced subject-matter experts dedicated to ensuring integrity, compliance, and ethical excellence in non-clinical research activities, studies, and processes supporting Takeda's R&D pipeline. Through strategic leadership, impactful stakeholder engagement, and championing an enterprise-wide quality culture, the Head of Research Quality drives organizational success and reinforces Takeda's commitment to industry-leading standards.
Accountabilities:
Establish and implement a comprehensive global strategic vision for Research Quality, ensuring sustained and impactful contributions to the enterprise. Align this vision with the overarching goals of Research and R&D Quality leadership.
Design oversight strategies and effectively deploy resources to mitigate compliance risks for Research non-clinical studies conducted externally in non-OECD Mutual Acceptance of Data system countries.
Cultivate influential relationships with key stakeholders to maintain an in-depth understanding of R&D and Research strategies. Leverage this insight to proactively anticipate and address impacts on Research Quality, driving business growth and success.
Direct the Research Quality function in designing, implementing, and refining processes that ensure Takeda's non-clinical Research activities are conducted with the highest integrity and compliance with Takeda standards and global regulatory requirements.
Architect strategies to foster a culture of continuous improvement, leading initiatives across internal stakeholder groups to uphold quality, compliance, and data integrity throughout Research programs and projects.
Spearhead digital transformation and the adoption of cutting-edge science and technology to support data-driven processes and decision-making within Research Quality.
Mentor and empower direct and indirect reports across Research Quality, promoting personal development and driving high-performance teams.
Develop and sustain collaborative relationships with Research leaders to facilitate productive discussions and align strategies and priorities.
Provide strategic oversight to enhance capabilities, mechanisms, and processes for proactive quality risk management across the global Research organization's activities and programs.
Maintain and expand knowledge of global regulatory requirements and trends, identifying gaps and implementing solutions to position Takeda at the forefront of industry expectations.
Implement strategies for the ongoing development and success of Research Quality, including talent development, succession planning, resource allocation, and budget management, aligning initiatives with R&D Quality and Global Quality.
Offer strategic input to the R&D Quality Leadership team on key goals, initiatives, resource planning, and budgetary considerations, ensuring alignment with organizational objectives.
Drive strategic alignment and successful achievement of shared goals through collaboration with other functions in R&D Quality and Global Quality.
Identify areas of risk and improvement, presenting solutions to address these challenges effectively.
Undertake additional duties as assigned, contributing to the overall success of the organization.
Education & Competencies (Technical and Behavioral):
Minimum requirements:
Bachelor's Degree in Chemistry, Biology, Engineering or related field
12+ years of increasing responsibility and experience in the biopharma/biotech industry
8+ years of Quality/Compliance experience
Prior management experience
Preferred requirements:
Advanced degree in Chemistry, Biology, Engineering or related field
Experience working in biopharmaceutical research
Desired skills & competencies
In-depth knowledge of global regulations governing biopharmaceutical research, with the ability to effectively translate and articulate strategies to ensure compliance.
Proven leadership, collaboration, and influencing skills, coupled with a demonstrated ability to solve problems and drive impactful change.
Proficiency in working with diverse individuals across all organizational levels.
Exceptional interpersonal, verbal, and written communication skills, enabling successful interaction with internal stakeholders and vendors.
Adaptability and flexibility to thrive in dynamic environments, along with the ability to manage and deliver multiple projects on time.
Strong attention to detail and organizational expertise, with a capacity to work independently across global settings and navigate organizational complexities.
#GMSGQ #ZR1 #LI-LR1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Base Salary Range:
$208,200.00 - $327,140.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Auto-ApplyADME Project Leadership for Genetic Medicines
Boston, MA job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Our diverse ADME team is seeking a dedicated scientist with an interest in the discovery and clinical development of genetic medicines, including si RNAs, ASOs, mRNAs, gene editing, and gene therapy. We are committed to advancing scientific boundaries to develop transformative therapeutics that address the underlying causes of diseases across a wide range of therapeutic areas. Applicants with strong problem-solving abilities and innovative thinking are encouraged to apply to join our team at the expanding Boston campus.
Lilly's agile ADME team collaborates closely with biologists, chemists, engineers, and various other R&D functions to deliver novel genetic medicines to patients. Team members support each other through shared learning and collective responsibility for all stages of the discovery and development process for next-generation genetic therapies. We strive to foster professional growth while advancing science to provide safe and effective new treatments to patients. Prospective candidates who are motivated, collaborative scientists interested in spearheading innovation in genetic medicine therapies are invited to connect with us and contribute to improving patient outcomes globally.
A high-quality candidate will demonstrate the following:
* High learning agility and a keen ability to articulate and efficiently test ADME and DMPK hypotheses for complex novel molecules
* Strong working knowledge in fundamental pharmaceutics, pharmacokinetics/pharmacodynamics, and ADME principles - especially as they relate to novel genetic medicine therapeutic modalities
* Understanding of pharmaceutical regulatory guidance and expectations
* Agile interrogation of diverse data (e.g., in silico, in vitro, in vivo) to interpret complex data sets and to derive mechanistic understanding of drug action and ADME/DMPK characteristics
Lilly seeks a skilled ADME / DMPK scientist who will:
* Lead and innovate in a multidisciplinary team environment with primary responsibility for ADME studies to support preclinical and clinical development of the Lilly genetic medicines portfolio
* Design, implement, and interpret hypothesis-driven studies to inform key ADME, PK/PD, and toxicokinetic (TK) questions
* Integrate ADME, PK and PK/PD endpoints with discovery chemistry and biology data to guide preclinical drug design, optimization, and delivery strategies.
* Engage, innovate, and collaborate with cross-functional colleagues and interdisciplinary teams
* Lead the preparation of ADME portions of regulatory communications and documents to support clinical development, new drug applications, and line extensions and interact with global regulatory authorities
* Build relationships through coaching and mentorship with fellow scientists at all levels
* Possess excellent written and verbal technical communication and the ability to constructively lead, guide and influence teams
'
Basic Requirements:
Ph.D. in Biochemistry/Biology/Pharmacokinetics/Bioengineering/Pharmacology or a related scientific field
Zero to five years of experience as a scientist in a pharmaceutical and/or biotechnology company
Additional Skills/Preferences:
* Knowledge of DMPK and/or bioanalytical considerations for gene editing therapeutics
* Experience with PK/PD modeling and simulation
* Experience with targeted delivery and biodistribution of oligonucleotides and/or gene therapies
* Understanding of and experience with PCR, immunoassay, and/or LC/MS bioanalytical methodology
Additional Information:
This is a full-time position located in Boston, MA.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$156,750 - $250,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyAssociate Director - Clinical Operations
Boston, MA job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview
Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company's initial three programs - VERVE-101, VERVE-102, and VERVE-201 - target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. In 2024, Verve was named a Top Place to Work by The Boston Globe for the fourth consecutive year. Verve is headquartered in Boston, Massachusetts.
Responsibilities:
* Drive and oversee all aspects of clinical studies from planning to close-out, ensuring adherence to timelines, budgets, and regulatory guidelines (FDA, EMA, GCP, ICH) using a risk-based approach.
* Develop and implement operational plans for clinical studies, managing CROs and vendors to ensure high-quality execution.
* Lead internal clinical trial team meetings, tracking key study metrics (e.g., enrollment, site feasibility, and data collection) to ensure progress and alignment with company goals.
* Partner with cross-functional teams (e.g., Clinical, Regulatory, Supply Chain) to support the strategic development and execution of clinical programs.
* Partner with cross-functional team and CRO to ensure patient recruitment and retention strategies are carried out effectively to facilitate on-time study enrollment.
* Ensure efficient database lock by overseeing monitoring plans and taking part in data review and reconciliation efforts.
* Contribute to the development and review of key regulatory documents (e.g., Protocol, Investigator Brochure, Clinical Study Report, Informed Consent Forms, patient-facing materials, and vendor plans).
* Assist in maintaining a quality-focused clinical infrastructure by developing, revising, and implementing SOPs to ensure operational consistency with GXP standards across trials and programs.
* Engage in the planning of quality assurance activities and coordinate remediation of audit findings.
* Lead vendor selection, contract/budget negotiation, and management (including RFP generation, review of SOWs, and Change Orders), serving as a point of escalation as needed.
* Develop and maintain project budget forecasts, ensuring efficient resource allocation, cost-effective execution, and punctual review of invoices.
* Provide ongoing oversight, maintenance and evaluate completeness of the Trial Master File (TMF) by performing periodic QC reviews to ensure the TMF is always "inspection ready".
* Lead, mentor, and develop a high-performing team by fostering collaboration, resolving challenges, and ensuring peak performance. Provide training and guidance to junior staff to support their growth and expertise in clinical operations.
* Set clear objectives, delegate responsibilities, and drive strategic alignment with company priorities.
* Cultivate an inclusive and collaborative culture, empowering team members and reinforcing company values.
* Tackle complex challenges by integrating diverse perspectives into innovative, actionable strategies.
* Make data-driven decisions, providing insightful recommendations to shape project timelines, goals, and resource allocation.
* Build strong relationships with senior management and external partners, influencing key project outcomes and ensuring strategic alignment.
* Partner with internal teams and external partners to ensure seamless execution of clinical studies. Foster strong relationships across departments to align objectives, streamline workflows, and drive strategic decision-making.
Basic Qualifications/Requirements:
* Bachelor's degree in a life science, allied health field, or other relevant field (e.g. nursing, medical or laboratory technology).
* At least 9 years of relevant experience.
Additional Skills/Preferences:
* Proven ability to lead teams, manage projects, and solve complex problems.
* Strong communication skills, with the ability to persuade and influence partners in sensitive, high-impact situations.
* High emotional intelligence, with the ability to manage both your own emotions and those of others, fostering a collaborative and positive work environment.
* Skilled in conflict resolution and maintaining relationships in challenging scenarios.
* Experience managing contracts, budgets, resources, and schedules to meet performance and project requirements.
* Strategic thinker with the ability to clarify and structure ambiguous problems.
* Experience in policy development and implementation with potential company-wide effects.
* Ability to build and maintain strong team dynamics, proactively preventing and resolving challenges.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$127,500 - $187,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyDigital Consumer Experience Design
Cambridge, MA job
Job Title: Digital Consumer Experience Design About the Job Join the team transforming how healthcare is delivered for chronic and specialty conditions worldwide. In General Medicines, you'll help drive meaningful outcomes in diabetes, transplant, and immunology - with the scale and urgency patients deserve.
About Sanofi EDGE:
Sanofi EDGE - Building a Healthier Future, Together
At EDGE, we're revolutionizing how individuals manage their health and well-being. We believe that lasting health behavior change is best achieved through a supportive ecosystem that
includes not only clinical guidance but also the encouragement and practical assistance of a user's care circle. Our platform empowers individuals to set meaningful health goals, track their progress, and connect with their support network, all grounded in evidence-based principles and a deep understanding of human motivation. We're a passionate team dedicated to creating a user-centered experience that drives meaningful health outcomes and fosters long-term engagement.
The Opportunity:
We are seeking a talented and passionate UX/UI Designer to join our growing product and experience team. As a key member of the team, you will play a crucial role in shaping the user experience of our health management platform. You will be responsible for translating user needs, business requirements, and strategic goals into intuitive, engaging, and effective design
solutions. You will collaborate closely with product managers, engineers, and researchers to create a seamless and empowering experience for our users and their care circles. Ideally, you will bring experience designing for consumer health applications, understanding the unique challenges and opportunities within this space.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities:
* Lead and contribute to the end-to-end design process, including detailed UI specifications and visual design.
* Develop a deep understanding of our users, their motivations (in formed by self-determination theory), and their care circle dynamics through user research, usability testing, and data analysis in collaboration with product and user research team members.
* Create user flows, wireframes, prototypes, and high-fidelity mockups that effectively communicate design ideas and solutions.
* Design intuitive and accessible user interfaces that are consistent with our brand guidelines and design system.
* Collaborate closely with product managers to define product features and translate them into user-centered design solutions.
* Work effectively with engineering teams to ensure the successful implementation of designs.
* Participate in design reviews and provide constructive feedback to other team members.
* Stay up-to-date with the latest UX/UI trends, best practices, and technologies, particularly within the digital health landscape.
* Contribute to the evolution and maintenance of our design system.
* Advocate for the user throughout the product development lifecycle.
About You
Qualifications:
* Bachelor's degree in Design, Human-Computer Interaction (HCI), or a related field, or equivalent professional experience.
* Proven experience (ideally 3+ years) as a UX/UI Designer, preferably with experience in consumer-facing digital products.
* Strongly preferred: Experience designing for consumer health applications, with an understanding of health data privacy (e.g., HIPAA), accessibility standards (e.g.,WCAG), and user behavior in health management.
* A strong portfolio showcasing user-centered design solutions and demonstrating a clear understanding of UX principles and UI best practices.
* Proficiency in industry-standard design and prototyping tools (e.g., Figma, Miro, Adobe XD).
* Excellent communication, collaboration, and presentation skills.
* Ability to work independently and as part of a cross-functional team in a fast-paced environment.
* A strong understanding of user-centered design methodologies and the ability to translate research insights into actionable design decisions.
* A passion for improving people's lives through thoughtful and effective design.
* Familiarity with agile development processes.
Bonus Points:
* Experience designing for behavior change or social support platforms.
* Knowledge of self-determination theory and its application in digital product design.
* Experience working with design systems.
* Understanding of front-end development principles (HTML, CSS, JavaScript).
* Experience using AI to create workflow efficiency
To Apply:
Please submit your resume and a link to your online portfolio showcasing your relevant work. In your portfolio, please highlight projects that demonstrate your user-centered design process and your ability to solve complex design challenges. If you have experience in consumer health, please specifically call out those projects.
Why Choose Us?
* Bring the miracles of science to life alongside a supportive, future-focused team.
* Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SG
#LI-GZ
#LI-Onsite
#vhd
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$125,250.00 - $208,750.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
Auto-ApplyPCP/Endo Business Specialist-Boston North
Boston, MA job
The PCP/Endo Business Specialist is responsible for developing and implementing a plan for maximizing net sales of BIPI and co-promoted diabetes products that aligns with direction from BIPI commercial leadership and with BIPI guidelines, policies, and directives. The PCP/Endo Business Specialist will conduct their business with key targeted healthcare providers and community hospitals, and may have additional responsibilities in teaching hospitals, federal and military hospitals, managed health care facilities, group purchasing organizations, integrated delivery networks, etc.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
**Compensation Data**
This position offers a base salary typically between ($95K) and ($153,100k). The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits please click here. (*****************************************************************
**Duties & Responsibilities**
+ Utilizes product knowledge and demonstrated selling skills in order to influence targeted health care professionals to support the use of BIPI promoted diabetes products. Executes brand strategies to ensure that company sales and marketing messages are delivered appropriately to customers. Establishes and maintains effective communication/cooperation/coordination with co-promotion partners and BIPI employees.
+ Completes pre-call plans to meet key stakeholder needs. Builds discussion around customer needs and opportunities. Fosters customer network development and communication. Has accurate and timely follow-up discussions with customers. Fosters ongoing trust with customer as relationship develops. Uses appropriate BIPI Sales Training techniques to facilitate the customer decision making process. Coordinates the engagement of healthcare providers through a range of personal and non-personal channels, according to customer preferences.
+ Identifies top plans for customers. Engages customers in comprehensive discussions on the payer environment, co-pays, and formulary access. Works with Managed Care Area Managers to generate and sustain support for products on MCO formularies. Develops and influences an extended team to pull-through MCO decisions. Delivers on "continuation of care" model, including discharge protocol, treatment algorithms, disease management, etc.
+ Analyzes qualitative and quantitative territory information to optimize territory business plan and customer calls. Monitors local market conditions for changes that impact business. Develops plans to optimize allocation of key resources, including samples, co-pay cards, funds for speaker programs, and funds for in-office meals. Adjusts implementation plans on a regular basis (speaker mgmt., advocate development, etc.). Leverages opportunities that meet both territory and brand tactics. Utilizes supporting analysis tools to plan activity, report and monitor resource utilization, and maintain account and customer records. Completes all administrative responsibilities as directed by management. Successfully completes all Sales Training requirements.
+ Identifies thought leaders, innovators and advocates to support BIPI products. Works with trained speakers for diabetes topics and products. Provides feedback and follow-up to speakers and attendees. Initiates contacts and network-building among advocates and customer groups. Develops plans to develop speakers and thought leaders. Manages programs and budgets to stay within standards.
+ Works effectively with all customer-facing roles (i.e. Account teams, Medical teams, etc.) in a given geography to meet customer needs and deliver net sales objectives. Demonstrates strong collaboration and communication as customers evolve and ownership of accounts transition from traditional to account based.
+ Performs all Company business in accordance with all regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community.
**PCP/Endo Business Specialist Requirements**
Bachelor's degree from an accredited institution is preferred.
A minimum of two (2) years successful sales and/or marketing experience in pharmaceutical/healthcare industry, pharmacy, B2B, customer engagement services or equivalent
Experience in diabetes therapeutic area preferred.
History of successful performance
Meets expectations for the key competencies required for this role
Proficiency in Excel, Word, Outlook, and database applications
Ability to travel (may include overnight travel)
Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership.
Valid Driver's License and an acceptable driving record
Authorization and ability to drive a Company leased vehicle or authorized rental vehicle.
Physical Demands / Surroundings
Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs.
Visual Demands
Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions.
Temperaments/Mental Requirements
Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment.
Level of Proficiency
Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements.
Attendance / Schedule
At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment.
Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities.
These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed.
It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. "Export Laws" means the Export Administration Regulations ("EAR") of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time.
**Executive PCP/Endo Business Specialist**
Experience in diabetes therapeutic area preferred
History of successful performance
Meets expectations for the key competencies required for this role
Proficiency in Excel, Word, Outlook, and database applications
Ability to travel (may include overnight travel)
Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership.
Valid Driver's License and an acceptable driving record
Authorization and ability to drive a Company leased vehicle or authorized rental vehicle.
Physical Demands / Surroundings
Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs.
Visual Demands
Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions.
Temperaments/Mental Requirements
Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment.
Level of Proficiency
Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements.
Attendance / Schedule
At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment.
Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities.
These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed.
It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. "Export Laws" means the Export Administration Regulations ("EAR") of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Postdoctoral Scientist - Antibody-RNA Conjugation, Genetic Medicine
Boston, MA job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
We serve an extraordinary purpose. For more than 140 years, we have worked diligently to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges.
At the Lilly Innovation Center in Boston Seaport, Massachusetts, we explore how next generation therapeutics, new technologies, data analytics and new care models can improve patient health and the healthcare system. Our team in Boston shares a real passion for challenging conventional wisdom and creating an environment that embraces creative, break-through concepts. The Center offers a start-up environment with large company support. It is located in the heart of Massachusetts' exploding science and technology cluster and is within walking distance of some of the best academic and industry innovators in the world.
We are seeking a highly motivated postdoctoral fellow to join our Genetic Medicine team at Eli Lilly in Boston MA. The successful candidate will possess a strong background in synthetic organic chemistry and experience in molecular design. They will be responsible for designing, synthesizing, and characterizing novel linkers for drug conjugates, with a focus on effective extrahepatic delivery. As part of a platform team, this individual will formulate linker chemistry strategies and investigate kinetics of payload-linker release to advance the RNA modality. Success in this role requires ability to solve complex problems, challenge the status-quo, and excel in communication and collaboration within a multidisciplinary team-oriented environment.
Job Responsibilities:
* Develop novel linker strategies for antibody-RNA conjugates and bioconjugation methodologies. Design and synthesize novel linkers for controlled drug release.
* Collaborate closely with ADME teams to develop robust bioanalytical methods and to investigate PK/PD relationships for antibody-RNA conjugates.
* Contribute to optimization of internal antibody-RNA conjugate workflow.
* Work productively and safely in the laboratory; and maintain good practice in writing experimental reports in an electronic lab notebook.
* Communicate experimental results and project progress with supervisor and at team/department meetings.
* Publish/share original research externally (presentations, peer-reviewed articles, and conferences).
Basic Qualifications:
* Ph.D. in synthetic chemistry, chemical biology, or related scientific field
Additional Skills/Preferences:
* Extensive knowledge of cutting-edge modern organic chemistry, linker design and complex molecule synthesis.
* Understanding advanced analytical and purification techniques.
* Experience in antibody-drug conjugates and/or oligonucleotide chemistry will be preferred.
* Proficiency in independently executing research tasks.
* High learning agility in the field of new scientific concepts and drug modalities.
* Strong problem-solving skills with creative solutions in constructing complex molecular systems.
* A proven track record of significant contributions to research projects, substantiated by first or co-authorship on peer-reviewed scientific publications.
* A track record of productive collaborations in interdisciplinary team environment.
* Excellent communication and organizational skills
Additional Information:
* This position is not permanent. It is for a fixed duration of two years with potential to extend to 3 years and for maximum of up to 4 years. You will have opportunities to apply for full time positions after your duration is complete
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$58,000 - $100,320
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyTrial Master File (TMF) Specialist Oncology
Marlborough, MA job
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF.
Key Responsibilities
* Responsible for overall quality, maintenance, and completeness of Trial Master Files.
* Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues.
* Develop project specific TMF plan and structure and update the plan as needed.
* Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained.
* Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements.
* Act as a liaison between the Site IRBs and study team to resolve queries and concerns.
* Provide study team reports or updates regarding status of TMF on a regular basis.
* Participate in audits and provide documents as requested.
* Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings.
* Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings.
* Champion best practices for building and maintaining TMF health.
Professional Experience / Qualifications
* BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings
* Knowledge of and direct experience with Trial Master Files.
* Prior eTMF (e.g. Veeva) administration required.
* Strong Microsoft Office skills required.
* Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2).
* Fundamental knowledge of the conduct of clinical trials is preferred.
* Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment.
The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Auto-ApplySenior Statistician / Principal Statistician
Devens, MA job
**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
The Senior Statistician / Principal Statistician is a core team member of the global statistics group, responsible for providing statistical support for drug substances, APIs, and drug products across the BMS global internal and external manufacturing network. The position resides in Manufacturing Sciences and Technology within Bristol Myers Squibb's Global Product Development and Supply (GPS).
**Role & Responsibilities:**
+ Apply statistical techniques to facilitate better decision-making and improve business operation.
+ Regularly interact with management of different levels in strategy meetings. Contribute to strategic planning to ensure statistically optimized non-clinical development plans and assist in the creation of strategic objectives for regulatory filings.
+ Provides leadership and statistical SME support for complex data analysis requests, including critical investigations, specification settings, stability analysis, and yield improvement initiatives. Takes accountability for ensuring quality and timely deliverables.
+ Collaborates with global and site functions to identify areas for improvement in yield, robustness, and quality by applying statistical methods.
+ Manages multiple studies to ensure consistency and adherence to standards within manufacturing and quality area
+ Identify opportunities and drive innovation in advanced analytics and AI/ML techniques through process and quality applications.
+ Act as a scientific and strategic partner to effectively engage with the matrix team in the drug manufacturing process and quality assurance.
+ Connect and communicate with key stakeholders and the leadership team with statistical work in a clear, logical, complete, and transparent manner to support data-driven decisions.
+ Prepare statistical courses and provide training to scientists. Mentor junior staff, proactively help with both their technical and career development, and seek general feedback and technical input from colleagues.
+ Maintain awareness of external trends in advanced analytics and represent BMS at industry forums and conferences. Maintain and expand expertise in various computing tools to leverage internal and external data sets to drive decisions. Examples of such tools include R, Spotfire, SAS, etc. Continue development of various analysis tools to improve the process.
+ Contributes to external and internal statistical community of practice.
**Experience & Qualifications:**
+ Senior Statistician: Bachelor's degree with 7+ years of experience or master's degree with 4+ years of experience or PhD with 2+ years of experience
+ Principal Statistician: Bachelor's degree with 9+ years of experience or master's degree with 7+ years of experience or PhD with 4+ years of experience in Statistics or a related field.
+ High degree of technical competence and excellent communication skills, both oral and written
+ Able to manage project timeline and quality of deliverables
+ Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo
+ Have strong leadership skills and experience in working/managing a team.
+ Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.
+ Experience in a cGMP-regulated environment, preferably gained through direct support of commercial manufacturing.
+ Extensive knowledge of FDA/EMEA cGMPs and other global regulatory compliance guidelines (e.g., ICH) for drug manufacturing, packaging, and distribution.
+ Proficiency in scientific computing/programming /software (SAS, R or Python, JMP) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Compensation Overview:**
Devens - MA - US: $115,860 - $140,389
New Brunswick - NJ - US: $108,270 - $131,201
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit *************************************
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
**Supporting People with Disabilities**
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to ************************** . Visit careers.bms.com/ (****************************************** eeo-accessibility to access our complete Equal Employment Opportunity statement.
**Candidate Rights**
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: *********************************************
**Data Protection**
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at **************************************** .
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R1596553
**Updated:** 2025-12-12 03:11:19.160 UTC
**Location:** Cruiserath-IE
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Senior Specialist, Product Data Management
Devens, MA job
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
As part of BMS global supply chain management, the Cell Therapy Product Data Management (CT PDM) team works to establish and manage those processes and procedures which identify, integrate, and align key product data across all cell therapy sites and systems in support of commercial and clinical GNSP operations.
The Senior Specialist, Supply Chain Product Data Management will identify data owners and engage, define, coordinate, and document key data management processes, along with respective roles and responsibilities, for the coordination of data entry, reporting, and exception handling in IBP planning systems and the ERP landscape.
This position will implement data governance standards and principles working across data stewards in acquisition, alignment, sequencing, and timely entry of key data elements to harmonize data management activities in a multi-system, multi-site, cross-functional, collaborative environment.
To accomplish this, the position will:
* Define basic work flows for proper alignment and sequenced entry of master data as needed.
* Develop and refine global PDM processes leveraging available tools and system functionality.
* Ensure overall data accuracy, input, and readiness in a timely manner.
* Engage and maintain cross functional support of the process to ensure data integrity and alignment.
* Responsibilities will include, but are not limited to, the following:
* Direct support of the product data configuration process which ensures accurate translations of demand to cell therapy supply.
* Ensures quality of master data in ERP and Planning systems.
* Develop and document processes with other functional data owners to support ongoing maintenance and data integrity.
* Provide end user training for Supply Chain Planning System users as needed.
* Partner with BPM and IT for enhanced solutions, functionality, and data management capabilities in response to business and program requirements.
* Define and implement service level agreements and performance targets concept for key applications and services.
* Coordinate cross-site integration of master data inputs, procedures, and governance polices in boundary systems.
* Provide visibility on delivered service levels to all key stakeholders.
* Ensure compliance to internal and external requirements, regulations, local and global procedures.
* Onboard, train, mentor new staff and help develop Product Data Management group.
* Skills/Knowledge Preferred:
* Minimum bachelor's degree with a background in Supply Chain Management, Business, or Engineering.
* 2 to 4 years prior experience in master data management role interacting with materials management, manufacturing operations, demand planning, supply planning, quality, supplier QA, finance, and regulatory organizations.
* Strong process development background and data savvy.
* Strong interpersonal and outstanding communication skills.
* Strong attention to detail.
* Hands-on team leader and team player willing to work in an environment where individual initiative, accountability, and professional maturity are required.
* Strong project management experience.
* Advanced time management and organization skills with ability to reprioritize with business needs.
* Strong PC experience, Microsoft Office Suite experience required including; Excel; Outlook; PowerPoint.
* Oracle EBS / Advance Supply Chain Planning or IBP/SAP experience preferred.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
Bothell - WA - US: $80,410 - $97,438
Devens - MA - US: $78,220 - $94,781
Madison - Giralda - NJ - US: $73,100 - $88,580
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit *************************************
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: *********************************************
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at *****************************************
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Auto-ApplyExecutive Director - Mass Spectrometry-based Biomarker Discovery - Neuroscience
Boston, MA job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly's Neuroscience Research team is at the forefront of developing cutting-edge therapies and diagnostics for brain disorders. Biomarkers play a crucial role in clinical trials, providing insights into patient selection, therapeutic efficacy, safety, and mechanisms of action. We seek an accomplished biomarker expert, who has vast experience in mass spectrometry-based work. The successful candidate will lead our efforts in biomarker discovery and validation, enabling the diagnosis and treatment of neurodegenerative conditions. As Executive Director (or potentially Associate Vice President) you will drive the strategic and technical development of biomarker assays that are instrumental in the advancement of our neuroscience pipeline. The role will be situated at Lilly's research facilities in Boston, within a newly established unit led by Dr. Kaj Blennow, Vice President of Neuroscience Biomarker Development. you will oversee and mentor a skilled team of biomarker researchers, fostering innovation and scientific excellence
Key Responsibilities:
* Lead the development and validation of novel mass spectrometry-based biomarker assays for early- and late-phase clinical trials in neurodegenerative diseases, including Alzheimer's, Parkinson's, ALS, and rare brain disorders.
* Oversee and mentor a team of biomarker researchers at Lilly's laboratories in Boston, focusing on mass spectrometry-based assay development.
* Serve as a scientific and technical expert for in-house and outsourced biomarker discovery efforts, guiding experimental study design and analytical strategies.
* Collaborate cross-functionally with internal stakeholders (medical, operations, statistics, regulatory) and external partners (CROs, academic institutions) to ensure biomarker validation and successful integration into clinical programs.
* Communicate findings through presentations, publications, and strategic discussions, reinforcing Lilly's leadership in biomarker innovation.
Basic Qualifications:
* PhD in Neuroscience, Biochemistry or a related field, with 8+ years of industry, academic, or postdoctoral experience experience in biomarker development, with recognized expertise in mass spectrometry-based assays for brain diseases.
Preferred Skills & Experience:
* Proven leadership in managing and mentoring biomarker research teams in academic or industry settings.
* Deep knowledge of mass spectrometry technology including instrument setup, optimization and maintenance.
* Deep understanding of mass spectrometry-based assay development, validation, and regulatory requirements for biomarker applications in clinical trials.
* Strong strategic thinking, problem-solving abilities, and the ability to drive innovation in biomarker discovery.
* Excellent communication, collaboration, and negotiation skills to influence both internal and external stakeholders.
* Demonstrated ability to translate scientific insights into impactful clinical applications.
Join Lilly in shaping the future of neuroscience by advancing biomarker-driven precision medicine. If you are a leader in biomarker discovery looking to make a meaningful impact, we invite you to apply.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$184,500 - $321,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-Apply