Post job

Merck jobs in Cambridge, MA - 713 jobs

  • Sr. Oncology Sales Representative - Mobile/Montgomery, AL

    Merck 4.6company rating

    Merck job in Boston, MA

    Our Sales team support our customers by providing clinical information about products, educational information, clinical training programs and resources. We support healthcare providers and healthcare systems meet the goals of the patients in their communities. Our Company's Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of dauntless, forward-thinking individuals achieves this through an unwavering commitment to supporting accessibility to medicine, providing new therapeutic procedures, and collaborating with governments and payers to ensure that people who need medicines have access to them. At our company, our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe. As we continue to grow and define the Oncology market of the future, we are looking for dynamic, entrepreneurial individuals who thrive in a team environment and are driven to succeed. The Oncology Sales Specialist is a key member of our customer facing organization and is responsible for partnering with customers to address identified needs, educating key stakeholders about our leading immunotherapy compound, and communicating our vision to the larger Oncology community. + This is a field-based sales position that will cover the **Mobile/Montgomery, AL** territory. + The selected candidate must reside within the territory. + Overnight travel may be required about 25% of the time. + Travel (%) varies based on candidate's location within the geography. **General Responsibilities:** + Demonstrate in-depth knowledge of how to create a compelling and logical rationale for the value of products and how to contrast, compare, and position our company brand(s) versus competition using appropriate resources in informed discussions about products with HCP customers - knowing when/how to seek and provide additional information + Act as primary point of contact for customer. Meet with key customers/personnel to understand practice structure, business model, and key influencers. + Possess knowledge of cancer staging and possible treatment options and dosing schedules associated with different tumors/diseases, with comprehensive understanding of the impact of those options on the patient. Must understand impact and use of clinical trials in multiple tumor types/therapies, both in impact on promoted products and in practice behavior of the account. + Ability to analyze and identify trends in a complex buying environment. This includes the multiple channels of drug distribution, Oncology GPO's, wholesalers and specialty pharmacies. Review and evaluate patterns for products purchased and prescribed, outpatient vs in-patient infusion, as part of hospital contract, etc. + Demonstrate ability to understand complex account interdependencies in order to develop both short- and long-term account plans in conjunction with a wide array of stakeholders, proactively working with the account team and supervisor (known as the Customer Team Leader) to effectively execute the account plan. Share learnings and best-practices from one customer to help other customers meet their needs. + Influence beyond their specific geography or product area demonstrate advanced ability to ask strategic, insightful questions to obtain information on customer needs from all stakeholders in oncology accounts, using the insights to position our company Oncology brands and collaborate with customers on a customized strategy. + Collaborate and communicate effectively with extended "in-scope" customer team to ensure a consistent customer experience across our company's divisions and functional areas; ensure integration with the Key Account Manager, Nurse Educator, Field Reimbursement Associate, Medicare Account Executive, and other key stakeholders to share key customer learnings and support customer needs. **Position Qualifications** **:** **Minimum Requirements:** + Bachelor's degree with 6-8 years Sales experience OR a minimum of high school diploma with at least 10 years of equivalent experience + Equivalent experience can be: Professional sales experience, work experience in the healthcare/scientific field (including pharmaceutical, biotech, or medical devices) that is not sales related, professional marketing experience, or military experience + 2+ years of oncology field sales experience + Valid driver's license and ability to drive a motor vehicle + Travel the amount of time the role requires **Preferred Experience and Skills:** + Documented history of strong performance in a sales / marketing or oncology clinical role + Clinical oncology experience across multiple solid tumors (Women's cancer - Breast, Ovarian, and Cervical) + Candidates with 0 - 2 years of oncology field sales experience will be hired at the S2 Oncology Sales Representative level. + Candidates with 2+ years of oncology field sales experience will be hired at the S3 Oncology Sales Specialist level. oncosales **Required Skills:** Accountability, Account Management, Adaptability, Business Relationship Building, Business Relationship Management (BRM), Customer Engagement, Customer Experience Management, Customer Relationship Management (CRM), Data Analysis, Product Knowledge, Revenue Generation, Sales Forecasting, Sales Reporting, Sales Training, Service Excellence, Strategic Planning **Preferred Skills:** Oncology, Oncology Nursing, Oncology Sales Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $156,900.00 - $247,000.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 25% **Flexible Work Arrangements:** Remote **Shift:** Not Indicated **Valid Driving License:** Yes **Hazardous Material(s):** N/A **Job Posting End Date:** 01/31/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381669
    $156.9k-247k yearly 11d ago
  • Job icon imageJob icon image 2

    Looking for a job?

    Let Zippia find it for you.

  • Chromatography Expert

    Merck 4.6company rating

    Merck job in Bedford, MA

    Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. Chromatography Expert Your role: We are seeking a Chromatography Expert with an engineering background to support Protein A chromatography adoption by our clients. This is a customer facing role as part of a global Protein A focused team, where you will work in close partnership with MilliporeSigma's Account Managers to cater to client's technical needs which may include direction on PD trials and optimization, pilot and process-scale runs, column packing guidance, and troubleshooting issues that arise during operations. You will serve as a key technical contact supporting biopharmaceutical clients with critical chromatography purification projects. Your responsibilities are to: · Provide expertise to support clients with process development, scale-up, and implementation of JSR chromatographic resin used for antibody purification, via remote consultation or on-site support. · Design and execute experimental protocols to understand process sensitivity and troubleshoot operational issues with minimal supervision. Critically analyze data and model process behavior to characterize process performance or troubleshoot root cause. Clearly communicate recommendations to GMP biopharmaceutical customers. · Assist and train clients with resin column packing. · Serve as key interface with Sales, R&D, and Marketing teams to communicate Voice of the Customer and Market Trends. · Travel requirement up to 30% Minimum Qualifications: · Bachelor's of Science in Chemical Engineering or Biotechnology with 10+ year's related experience OR Master's of Science in Chemical Engineering with 8+ year's related experience OR PhD in Chemical Engineering or Biotechnology with 5-7+ years' experience. · 5-7+ years practical experience with downstream biologics purification in a manufacturing or process development environment, including a knowledge of scale-up, process transfer, and cGMP manufacturing. Preferred Qualifications: · In depth experience with chromatography operations at pilot or manufacturing scale, including column packing, process validation, and troubleshooting operational issues. · An understanding of bioprocess economics, as well as strong knowledge of scale-up and scale-down sizing principles. · A sound knowledge of process engineering fundamentals, especially fluid dynamics. · Ability to communicate technical concepts to colleagues and clients using excellent written and verbal communication skills. · Dependable, self-motivated, and able to thrive in an autonomous working environment. Pay Range: $85,300- $187,700 The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
    $85.3k-187.7k yearly 52d ago
  • Global Head of mRNA Research & Biomarkers

    Sanofi 4.3company rating

    Waltham, MA job

    A global biopharmaceutical company is seeking a Global Head of Research and Biomarkers in Waltham, MA. This executive role involves leading R&D for mRNA and LNP, strategizing biomarker optimization, and managing teams of scientists. Ideal candidates will have a PhD and over 15 years of experience in the biotech industry, alongside skills in molecular biology and team leadership. This is an opportunity to advance next-gen scientific innovations in vaccines. #J-18808-Ljbffr
    $69k-97k yearly est. 5d ago
  • NIGHT SHIFT: Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA

    Bristol Myers Squibb 4.6company rating

    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. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. The Specialist, QA Shop Floor, Cell Therapy will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Shifts Available: 6pm - 6am, rotating scheduling including holidays and weekends, onsite Responsibilities: Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations. Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy. Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members. Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures. Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques. Provide quality oversight for pre-planned return to service plans. Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners. Identify and propose improvements to programs, procedures, and practices. Review manufacturing batch records or QC testing records to ensure compliance with approved procedures. Review and provide feedback on documents such as forms, logbooks, and procedures. Maintain compliance with assigned learning plan. Provide integration support of newer team members. Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge Review and interpret the technical conclusions of a record/investigation and provide constructive feedback. Participate in quality and shift meetings. Build and maintain relationships with core partner functions and seek collaborative solutions. Share data/knowledge within team by acting as a champion for quality-culture. Knowledge and Skills: Must be action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking. Ability to understand, follow, and apply internal policies, procedures, and quality principles. Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management. Ability to assess an unfolding situation, diagnose the problem, and propose practical solutions. Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned work. Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraints. Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills. Active listening skills to understand diverse working perspectives. Contributes to a positive team environment. Able to independently make decisions based on data and facts, and recognizes when to escalate Seeks opportunities for improvement to quality and operational problems. Ability to work within pharmaceutical cleanroom environments. Experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management. Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms. Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc. Basic Requirements: Bachelor's degree in STEM field. High school diploma or associate's degree with equivalent combination of education and work experience is considered. 2+ years of relevant cGMP experience with 1+ year of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing. * 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: $83,540 - $101,228 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.
    $83.5k-101.2k yearly 4d ago
  • ASSOCIATE DIRECTOR, GPS STABILITY

    Bristol Myers Squibb 4.6company rating

    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 Associate Director Stability is responsible for stability product strategy and oversight of product stability programs for commercial large molecules Drug Substances and Drug Products. Activities include those associated with product stability strategy, stability program requirements, stability sample management, preparation, review and approval of stability reports and regulatory filings. The Associate Director is responsible for leading high-performance technical team, developing team and fostering company culture. Responsibilities The Associate Director Stability is accountable for the stability commercial program for large molecules Drug Substances and Drug Products. Accountable for new products commercialization and providing support to the sites or external manufacturing for new products commercialization. Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change. Accountable for the handling of annual commercial stability program for assigned products in coordination with sample management group. Provides technical expertise to the stability team. Provides support for authoring stability sections of filling dossiers for post-approval filings, and stability related responses to health authority inquiries. Approves the stability sections of filling dossiers, annual reports, product renewals, Annual Product Stability Reviews. Provide support for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues or capacity issues. Accountable for stability procedures and ensures consistency with site department and BMS groups procedures. Leads OpEx initiatives to streamline and standardize management of stability programs. Supports health authorities' inspection internal and external. Leadership skills: Leads the team and focus on the pipeline complexities to achieve milestones and objectives, while providing technical oversight, mentorship, and coaching. Leads with a global mind-set to direct and influence multiple remote teams Drives sense of team responsibility for group's success, promoting a high commitment to business goals and objectives Accountable for stability resources definition and budget. Fosters a culture focused on demonstrating high capacity for executing with company values and behaviors. Provides continuing development opportunities, including ongoing performance assessments Qualification: 10 years of relevant work experience required, preferably in a pharmaceutical environment. 2 years' experience as team manager. Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility. Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices. Expert Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods. Significant Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles. Excellent skills to drive development of technical or scientific initiatives for solving complex problems/issues, recommending and drive science-based decisions/ implementation of solutions. Significant experience on health authorities' inspections in front room. Excellent written and verbal communication skills. Leadership experience: Team, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation. Advanced knowledge of Microsoft office applications, LIMS, Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP). #LI-ONSITE 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: $168,930 - $204,702 New Brunswick - NJ - US: $157,880 - $191,312 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.
    $168.9k-204.7k yearly 7d ago
  • Advisor - RNA-LNP Process Development - BR&D

    Eli Lilly and Company 4.6company rating

    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. Summary The Lilly Bioproduct Research and Development (BR&D) organization is focused on the development and commercialization of parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. The organization is also committed to the development of genetic medicines which includes active investments in oligonucleotide development, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in building new platforms to support complex formulations such as lipid nanoparticles (LNPs), antibody drug conjugates, AAV, and other non-viral vector delivery vehicles. We are seeking a highly motivated engineer with experience in chemistry, manufacturing and control (CMC) of genetic medicines to drive innovation efforts in the process engineering of genetic medicine programs. This position is a full-time onsite role located at the Lilly Institute of Genetic Medicine in Boston. We are seeking a candidate with hands-on experience in process development of nonviral delivery vehicles, e.g., RNA-lipid nanoparticles, and ideally experience with oligonucleotide drug products. This candidate would collaborate across functions at Lilly's Boston and Indianapolis sites to advance portfolio assets. If you are interested in conducting innovative research, you should consider joining our diverse and high-performing team. Roles and Responsibilities: Build process capabilities for lab scale, early phase clinical scale, and scale up technologies for RNA-LNPs and other parenteral drug products. Support the development of portfolio assets (particularly RNA-LNPs), including assessing and mitigating process risks during scale-up through an understanding of in-process and final product critical quality attributes. Anticipate and manage increased workload during scale-up and GMP readiness phases. Work with project management and other technical leaders to execute complex tech transfer challenges across sites, including both internal and external manufacturing organizations. Help oversee supply chain readiness and ensure integration of novel excipients into regulatory filing packages. Implement processes to deliver drug product material for clinical trials and support generating data required for regulatory filings, including addressing CMC regulatory questions. Ensure consistency in technical deliverables and documentation across transfers. Partner with analytical colleagues and aid in the transfer and installation of analytical methods to assess developability of portfolio molecules, including familiarity with acquisition and analysis of chromatography methods ( e.g., SEC, HPLC, UHPLC methods). Cross-Functional Collaboration: Represent the product research & development organization on project teams. Partner with genetic medicines discovery, synthetic chemistry, toxicology, ADME, analytical, and device to support drug delivery, formulation, or process efforts. External Engagement: Establish and leverage strategic relationships with academic and industry partners to accelerate and access emerging innovation. Innovation: Drive a strong innovation agenda for the team leading to publications, presentations and industry wide influence. Leverage these innovations to advance the Lilly portfolio. This is a full-time onsite role (five days per week) in Boston, MA. Basic Qualifications: Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or a related field. 0-5 years of prior experience in nanoparticle formulations, oligonucleotide and/or gene delivery development programs, parenteral formulation, or process development. Experience with process development of RNA-lipid nanoparticle and/or oligonucleotide formulations. Familiarity with engineering fundamentals towards designing and optimizing manufacturing processes, or drug delivery platforms including RNAs and LNPs. Additional Skills and Preferences: Hands-on experience working with process equipment from lab to pilot scales is preferred. Previous experience with regulatory submissions of RNA-based therapies is preferred. Self-directed and highly motivated individual who wants to learn new techniques while continually pursuing research and publication goals. Excellent communicator (oral and written) with presentation experience, along with a strong publication record. Proficient in data analysis and reporting. Final job level (Advisor or Senior Advisor) will be based on the selected candidate's experience and qualifications and determined at the hiring manager's discretion. 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 $166,500 - $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
    $166.5k-244.2k yearly Auto-Apply 14d ago
  • Senior Autoimmune Immunology MSL - Field Leader

    Johnson & Johnson 4.7company rating

    Boston, MA job

    A leading healthcare firm is seeking a Senior Medical Science Liaison based in the Boston area. This role involves providing scientific information to healthcare providers and requires strong experience in immunology. Candidates should have a PharmD, PhD, or MD with at least 3 years in related fields. The position emphasizes relationship-building and territory planning, with a travel requirement of up to 70%. Competitive compensation and benefits are offered. #J-18808-Ljbffr
    $106k-137k yearly est. 2d ago
  • Digital Innovation & Technology Strategy - Global PK/PD & Pharmacometrics

    Eli Lilly and Company 4.6company rating

    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. Eli Lilly and Company is committed to using its innovation-based strategy to discover, develop and deliver innovative medicines that help improve the lives of people. The PK/PD & Pharmacometrics organization is at a pivotal moment: we're redefining how we harness decades of clinical data and model-informed drug development approaches through strategic AI and automation adoption. We are seeking a Digital Innovation & Technology Strategy Lead who will define and implement our multi-year roadmap for integrating artificial intelligence, machine learning, and automation technologies into our quantitative pharmacology and pharmacometric workflows. This role will help position us as an industry leader in AI-enabled drug development while ensuring scientific rigor, regulatory defensibility, and meaningful value creation. Key responsibilities * Develop and implement a comprehensive digital strategy for PK/PD & Pharmacometrics, identifying and prioritizing high-impact use cases that accelerate drug development and position PK/PD as an industry leader in AI-enabled quantitative pharmacology * Lead PK/PD's digital strategy as the primary work with internal and external partners, managing stakeholder relationships to accelerate value delivery from AI and automation investments * Evaluate emerging AI technologies for clinical pharmacology and pharmacometrics applications, leading proof-of-concept pilots and scaling validated solutions * Partner with IT, data science, and data engineering teams to implement AI solutions and establish data governance standards that ensure PK/PD data is AI-ready, accessible, compliant, and coordinated with existing systems and workflows * Collaborate with project leaders, pharmacometrician's, and cross-functional partners (e.g. Clinical Operations, Statistics, Regulatory Affairs) to ensure seamless AI integration across R&D and serve as the primary voice for AI strategy within PK/PD leadership and governance forums * Grow and implement organisational change strategies to drive AI adoption, including training programs, champion networks, and upskilling resources that address resistance and build organizational capability in AI/ML methodologies * Define success metrics and track value creation for digital/technology initiatives, maintaining a portfolio of use cases with clear ROI documentation and preparing executive-level cases and communications * Establish relationships with external partners (e.g. academic institutions, technology vendors, industry consortia, regulatory agencies) and contribute to thought leadership through publications and conference presentations, representing Lilly's vision for responsible AI adoption MINIMUM REQUIREMENTS: * An advanced degree in a relevant field * Minimum 10 years of experience in pharmaceutical R&D, with at least 2 years focused on AI/ML/digital technology applications in drug development * Experience in PK/PD modeling, pharmacometric workflows (e.g. population PK, exposure-response, dose optimization), and model-informed drug development principles * Experience implementing digital solutions in a regulated induestry environment Additional Skills/Preferences: * familiarity with data architecture, cloud computing, and innovative analytics platforms * experience crafting compelling cases and executive-level presentations * track record of external thought leadership through publications, conference presentations, or industry working groups * Hands-on experience with specific AI tools (e.g. Python/R/Matlab for ML, TensorFlow/PyTorch, cloud-based ML platforms) * Track record of successful pilot-to-production digital scaling * Hands on experience with PK/PD modelling and simulation and model-informed drug development Other Considerations: * Location: Indianapolis, IN or Boston, MA (hybrid work model available) * Travel: Domestic and international travel up to 20% (conferences, vendor meetings, cross-site collaboration) * Work Environment: Highly collaborative, matrixed organization requiring cross-functional relationships Innovation Culture: We encourage calculated risk-taking, rapid prototyping, and learning from failures 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 $177,000 - $308,000 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
    $177k-308k yearly Auto-Apply 9d ago
  • ADME Project Leadership for Genetic Medicines

    Eli Lilly and Company 4.6company rating

    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
    $156.8k-250.8k yearly Auto-Apply 60d+ ago
  • Senior Medical Science Liaison-Autoantibody Pipeline-Northeast

    Johnson & Johnson 4.7company rating

    Boston, MA job

    Job Function: Medical Affairs Group Job Sub Function: Medical Science Liaison Job Category: People Leader All Job Posting Locations: Boston, Massachusetts, United States of America, White Plains, New York, United States Job Description: Johnson & Johnson Innovative Medicine is searching for the best talent for a Senior Medical Science Liaison- Autoantibody Pipeline for the Northeast region. This is a field-based position located in the Northeast region, the ideal location is the New York or Boston area. The territory covers Massachusetts, Connecticut, Rhode Island, Maine, New Hampshire, Vermont, and New York City. About Immunology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *************************************** The Senior Medical Science Liaison (Sr. MSL) is responsible for providing fair balanced, objective, scientific information and education to opinion leaders (OLs), health care professionals, and to internal partners as required by scientific and business needs. The Sr. MSL is considered an established scientific and clinical knowledge lead on current and future J&J Innovative Medicine products per Therapeutic Area (TA) alignment. The Sr. MSL is responsible for staying abreast of current scientific and treatment landscape trends in their therapeutic areas of interest. The Sr. MSL provides research support for company and investigator-initiated research. The Sr MSL will function with high integrity and follow credo values. The Sr. MSL is responsible for building external relationships with identified OLs and health care providers (MD, DO, PhD, PA, NP, RN, Pharm.D., bio coordinators) and developing and managing a geographical territory. These relationships and engagements can include both virtual & in-person, with a prioritization of in-person engagements when appropriate. The Sr. MSL is responsible for developing and maintaining a territory strategic plan, which includes educational activities with identified OLs, HCPs, institutions, and community practices. The Sr. MSL role is one that requires a level of competency and experience in the disease state. The Sr. MSL is expected to possess foundational competencies in the areas of Influence & Results Focused, Communication, Stakeholder Engagement, Product & Therapeutic Area Knowledge, and Data Insights & Dissemination. The Sr. MSL will be expected to rapidly identify and compliantly collaborate with field-based partners to ensure support of the Healthcare Providers, which will positively impact the patients that they care for. The Sr. MSL will continue to enhance their skills in agility, applying the competencies of Change Management, Time Management and Innovation. The Sr. MSL is responsible for conducting all activities in accordance with current regulatory and health care compliance guidelines. This is a field based clinical position which required travel, primarily throughout assigned geography, with infrequent meeting travel outside of assigned geography. Travel for this role is estimated at 70%. Responsibilities: Consistently demonstrate strategic territory planning and ability to build strong relationships within the territory. Responsible for developing and maintaining a field strategic plan. Responds in a timely manner to unsolicited scientific inquiries of HCPs/investigators/health care systems/academic medical centers and population health decision makers integrating scientific data including real world evidence into real life practice to meet customer needs. Presents data and information in a manner appropriate to the audience and request. Execute plans regarding reactive and proactive outreaches as approved via the legal/HCC exceptions process. Integrates scientific data into real life practice to meet customer/audience needs, adapting interpersonal style to particular situations and people. Anticipates the responses of various individuals and teams based on their perspective. Prioritize franchise customer-based initiatives and field responsibilities, while balancing administrative duties and project responsibilities. Executes Research Initiatives: Leverages knowledge of standards of care and Janssen company/investigator sponsored clinical trials and competitor landscape to facilitate external-internal research communication. Engages with external investigators regarding unsolicited research inquiries and act as liaison to R&D, Medical Affairs and operations teams. Provides clinical trial support to identify potential sites, resolve issues with enrolled sites, and participate in meetings as appropriate, including site initiation visits and investigator launch meetings. Effectively leads at least one scientific or strategic Immunology project, exhibits strategic identification of educational gaps and elevates team acumen. Consistently demonstrates strong scientific acumen. Actively participate in team calls, trainings, & journal clubs through scientific dialogue, understanding of current standard of care, and regularly sharing of scientific news. Attends and provides leadership at scientific conferences to gather and understand new scientific information relevant to the company and the external scientific community. Medical insights: Actively listens for, documents, and shares medical insights. Proactively synthesize data and medical insights for MSL team and other partners Sets aside time for self-driven learnings on current scientific landscape. Role includes representing and supporting JNJ at relevant scientific or other key stakeholder meetings including congresses, symposia, advisory boards and investigator meetings. Role includes representing JNJ at speaking engagements at relevant scientific or other key stakeholder meetings. Continuous support Department Operations and Internal Partners: Performs all administrative requirements in a timely, accurate and compliant manner (e.g. expense reports, documentation of activities) Maintain focus and composure in uncertain circumstances with minimal direction. Provide regional and local support to enhance sales training initiatives and improve competencies of field personnel in partnership with Sales Learning and Development Communicates and collaborates with all field-based partners, and other Immunology MSL teams on a routine basis. Demonstrate the ability to partner with others to lead or participate in large scale projects. Maintains thorough understanding and competence in the following areas (regulatory and health care compliance guidelines; corporate policies on appropriate business conduct and ethical behavior; Medical Affairs SOPs and guidelines. Qualifications Required: A PharmD, PhD, MD, w/ 3+ years relevant hematology, immunology and/or auto/alloimmune disease experience Minimum 3 years MSL experience, and/or 2-3 years relevant work exp (clinical or research experience) Must be familiar with Microsoft Word, Excel, PowerPoint, and utilization of computers and remote technologies. Ability to travel up to 70 %. Preferred: Launch experience in rare disease is highly preferred. Significant experience giving presentations is highly preferred. Must be familiar with Microsoft Word, Excel, PowerPoint, and utilization of computers and remote technologies. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via ************************************** and internal employees contact AskGS to be directed to your accommodation resource. #LI-Remote The anticipated base pay range for this position is : $137,000 TO $220,000 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. ********************************************* #J-18808-Ljbffr
    $137k-220k yearly 2d ago
  • Summer 2026 Intern - Immunology New Product Launch Team

    Sanofi Us 4.3company rating

    Cambridge, MA job

    About the Job Sanofi is committed to becoming a leader in immunology with over 10 mid and late-stage clinical assets being studied across several immunological disease areas. The New Product Launch team was recently created to support the early commercial planning for this promising pipeline and to help prepare the company and the market for these new, potential treatment options for patients suffering from immunological diseases in the fields of dermatology, respiratory, rheumatology and gastroenterology. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: The New Product Launch (NPL) Summer Intern will report to a Senior Director within the NPL team to assist with one or more of the following projects: Work with the global brand teams and NPL commercial team to support the development of a preliminary US Brand Plan for any of our late-stage clinical assets, including rilzabrutinib and duvakitug Complete a competitor analysis within at least one of the following therapeutic areas: asthma / chronic spontaneous urticaria (CSU) / IgG4-related disease (IgG4-RD) / ulcerative colitis / Crohn's Disease to evaluate and summarize current treatments and existing competitors already in the space, therapies in development, and available resources and patient support programs Support market access assessment and early forecasting efforts to scenario plan various launch strategies Participate in market research projects and help identify any insights gaps for future planning About You Basic Qualifications: Currently enrolled and pursuing an MBA at an accredited college or university with the expectation that you will complete your current degree in the Spring of 2027 Must have completed the first year of your MBA program prior to the summer internship Must be enrolled in school the throughout the full duration of the internship with Sanofi 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: Desire to serve patients, passion for the patient Excellent communication skills, interpersonally savvy, ability to collaborate across boundaries Strong analytical skills, ability to package and present strategic insights and learning Highly organized with the ability to effectively manage multiple projects and priorities 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. 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-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.
    $88k-125k yearly est. Auto-Apply 25d ago
  • Disaster Recovery and IT Resilience Program Lead

    Merck 4.6company rating

    Merck job in Burlington, MA

    Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. Disaster Recovery and IT Resilience Program Lead - MilliporeSigma Life Science Reports to Head of Cyber Enablement & Compliance Your role: As a member of Cyber Enablement & Compliance, you play a pivotal role within the MilliporeSigma Life Science (LS) Cyber Security team. You are part of the global Cyber Security team, interfacing with the LS business and corporate Cyber Security. You will develop, implement, test and maintain strategies and plans to ensure MilliporeSigma LS can continue or quickly resume operations after a disruption such as a major disaster, technical failure or cyberattack. The role bridges the gap between business needs and technical solutions. The role will assess risks and threats, determine scope of Disaster Recovery (DR) requirements and govern the process to ensure all in-scope applications, infrastructure, cloud solutions, etc. have current, documented and tested plans. This person is also responsible for working with business leaders to define and understand their role during a disaster and fostering a culture of preparedness. The role partners with Life Science Business Risk Management, Business Continuity Planning, and Incident Response teams. Key Responsibilities: Lead the development, implementation, and maintenance of a Disaster Recovery program, including policies, procedures, and plans Build and maintain relationships with key stakeholders in business and technology to ensure alignment of DR strategies with organizational objectives Convey complex topics and strategies into consumable and actionable initiatives Conduct Business Impact Analyses to identify critical business functions and assess potential impacts of disasters as well as business requirements for RTO and RPO Ensure backup and recovery strategies are aligned to defined RTO/RPOs Educate staff on emergency procedures, recovery plans, and best practices Lead and coordinate disaster recovery testing, simulations, and failover exercises across systems and platforms Ensure coordination of DR efforts with internal and third-party providers Clearly communicate maturity of the overall DR program and MilliporeSigma LS readiness to respond Location: This position can be based in either our Burlington, MA or St. Louis, MO site. We do offer a hybrid flexible work arrangement. Who you are: Professional with a positive attitude and capable of contributing to a dynamic and team-oriented culture Bachelor's Degree or equivalent in Computer Science, Engineering or related field At least 6 years of experience of relevant IT roles including DR, BC, infrastructure, systems or information security following legal, regulatory, and industry standards and requirements (e.g. ISO/IEC 27001/27002, NIST CSF, NIS2, CRA, IEC62443, PCI DSS) Experience documenting and testing DR plans in a large enterprise. Familiarity with real-world disaster recovery scenarios. Demonstrated experience in developing and implementing incident response and recovery strategies for each. Strong understanding of IT infrastructure, systems, and disaster recovery techniques Familiarity with cloud platforms (Azure, AWS, and GCP) and hybrid IT environments Strong analytical and problem-solving skills with the ability to assess complex security issues and develop effective solutions Excellent verbal and written communication skills in English, capable of conveying complex security concepts to non-technical stakeholders Strong interpersonal skills and the ability to work collaboratively with cross-functional teams and external partners Broad knowledge of project management methodologies; experience managing complex, multi-stakeholder initiatives; ability to design and implement process improvements. Pay Range: $125,000-$175,600 The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
    $125k-175.6k yearly 16d ago
  • Specialist, Lead Clinical Manufacturing Associate, Cell Therapy in Devens, MA

    Bristol Myers Squibb 4.6company rating

    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: $43.84 - $53.12per hour 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 in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the 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. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ********************. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1596509 : Specialist, Lead Clinical Manufacturing Associate, Cell Therapy in Devens, MA
    $43.8-53.1 hourly Auto-Apply 60d+ ago
  • Director - Statistics

    Eli Lilly and Company 4.6company rating

    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. 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. Purpose: The Project Statistician at the Director level provides statistical leadership in multiple dimensions including: Provides technical leadership and expertise in initiating and implementing multi-disciplinary or cross functional projects that impact the Verve Gene-editing program and Lilly Research Laboratory, Leads the assessment and introduction of new statistical technology and methodology to apply to broader practice, Leads the development of clinical plans, innovative protocol designs, and statistical analysis plans in collaboration with physicians and/or medical colleagues, Provides consulting and statistical direction on priority clinical projects. Key Responsibilities: The job tasks listed below outline the scope of the position. The application of these tasks may vary, based upon current business needs. Statistical Trial Design and Analysis Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study. Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol and the statistical analysis plan, and conducting the actual analysis once a reporting database is created. Collaborate with data sciences in the planning and implementation of data quality assurance plans. Maintain currency with respect to statistical methodology, maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected. Influence team members regarding appropriate research methods Perform peer-review of work products from other statistical colleagues. Communication of Results and Inferences Collaborate with team members to write reports and communicate results. Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings. Respond to regulatory queries and interact with regulators. Therapeutic Area Knowledge Understand disease states, competitive landscapes, and regulatory environment in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor. Regulatory Compliance Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training. Statistical leadership and Teamwork Introduce and apply innovative methodology and tools to solve critical problems Merge scientific thinking and business knowledge to identify issues, evaluate options and implement solutions. Lead projects independently and work effectively across functions. Apply technical expertise to influence business decisions. Basic Qualifications: Ph.D. in Statistics OR Biostatistics At least 7 years of proven experience in clinical research and development Additional Skills/Preferences: Significant experience with clinical trials, medical research, and/or real-world evidence Technical expertise and application with working knowledge of experimental design and statistical analysis An established track record of developing and maintaining an area of statistical or collaborative research Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUG, etc Demonstrated problem solving ability and critical thinking Teamwork and leadership skills; ability to provide statistical leadership and technical expertise to influence business decisions. Interpersonal communication skills for effective customer consultation and collaboration Creativity and innovation Business process expertise associated with critical activities (e.g. regulatory submissions) 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 $193,500 - $338,800 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
    $114k-146k yearly est. Auto-Apply 5d ago
  • Executive Director - Mass Spectrometry-based Biomarker Discovery - Neuroscience

    Eli Lilly and Company 4.6company rating

    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
    $184.5k-321.2k yearly Auto-Apply 60d+ ago
  • Head of Process Analytical Technology - Mammalian Platform

    Sanofi 4.3company rating

    Framingham, MA job

    Job Title: Head of Process Analytical Technology - Mammalian Platform 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. About the Job Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. Are you ready to help create the future of biomanufacturing? At Sanofi, we strive every day to Take the Lead to innovate for patients with novel therapeutics and manufacturing technology. Your leadership skills and expertise in Process Analytical Technology (PAT) could be a key enabler that helps us realize that future together. The Mammalian Platform (part of Sanofi R&D) is responsible for the development, scale-up, and transfer of upstream and downstream processes and their control strategies for clinical and commercial manufacturing of therapeutic proteins produced from mammalian cell lines. In addition, the department actively invests in developing and implementing new technologies related to integrated and continuous biomanufacturing, process analytical technology (PAT), high throughput process development, and modeling. Ultimately, our goal is to design robust processes that produce safe and effective medicines as efficiently as possible. We are looking for candidates to lead our Process Analytical Technology activities across the Mammalian Platform including applications for both cell culture and purification processes. This individual should be able to combine innovation leadership skills with technical expertise to continuously evolve and lead teams in the delivery of our Process Analytical Technology roadmap. The incumbent will lead in a matrixed structure, leveraging resources across the platform's global footprint in both the United States (Framingham, MA) and France (Vitry) while representing the platform at the interface with our Commercial Manufacturing and Supply (M&S) organization. This role will report to the Global Head of Purification Development, providing a direct link to Mammalian Platform leadership to support sustained innovation and technology implementation in both clinical and commercial manufacturing applications. Main Responsibilities: * Lead the development and implementation of Process Analytical Technology for the Mammalian Platform, including cell culture and purification applications * Drive the design and evolution of our Process Analytical Technology roadmap to enable near-term implementation and long-term disruptive innovation * Represent the Mammalian Platform for PAT-related topics, interfacing with Commercial Manufacturing and Quality, as well as other Platforms within R&D (Microbial, Genomic Medicines, mRNA, Vaccines, Synthetics) * Engage relevant stakeholders across R&D and Commercial Manufacturing to ensure resources, budget, and implementation risk are adequately managed and communicated * Identify opportunities to improve our process development strategies and manufacturing approaches through the application of PAT * Act as a PAT champion across the Sanofi R&D and Manufacturing network * Mentor scientists across sites and teams fostering their career development and professional growth About You Basic Qualifications: * PhD. in Biochemical Engineering, Chemical Engineering, Analytical Chemistry, Physics, Bioengineering, Electrical Engineering, or related fields with at least 7 years of experience or a M.S. with at least 11 years of relevant experience or a B.S. with at least 12 years of relevant experience * Relevant industrial experience and/or academic experience in Process Analytical Technology development Preferred Qualifications: * Experience with spectroscopic Process Analytical Technology (Raman, Near-Infrared, Mid-Infrared, Fluorescence, UV-Vis) techniques * Experience with online or inline analyzers for Process Analytical Technology applications (HPLC, UPLC, LCMS, DLS, MALS) and auto-sampling techniques * Understanding of PAT-enabling digital architecture and its application in manufacturing settings (SynTQ, SIMCA-Online, Distributed Control Systems) * Familiarity with relevant Regulatory and Quality frameworks related to control strategy, method qualification, process validation, and data integrity * Understanding of upstream and downstream unit operations, process development, and technology transfer * Understanding of product quality attributes of therapeutic proteins (antibodies, multi-specific antibodies, fusion proteins, enzymes) * Ability to lead a diverse, cross-functional, cross-site matrixed team * Excellent communication skills in both written and oral settings * High level of scientific curiosity and innovation mindset 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-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: $178,500.00 - $257,833.33 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.
    $178.5k-257.8k yearly Auto-Apply 2d ago
  • Director - Data Scientist, Lilly Gene Therapy

    Eli Lilly and Company 4.6company rating

    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 Responsibilities Lead and mentor a team of data scientists to deliver impactful analytics solutions. Develop and implement the organization's strategic vision for data science and AI, aligning with business goals. Collaborate with executives and leaders to address key business challenges using data science. Drive the creation and implementation of advanced machine learning and AI models to solve complex problems. Ensure best practices in model development, validation, and deployment. Stay updated on emerging trends and suggest innovative solutions. Work with data engineering and IT teams to ensure data availability, scalability, and accessibility. Oversee the optimization of data pipelines and workflows for large-scale analysis. Integrate data science insights into business processes across various departments. Provide strategic guidance on data insights to inform business decisions. Present analytical insights and recommendations to senior executives clearly and concisely. Lead reporting and performance tracking for data science initiatives, including KPIs and impact assessments. Hire and manage a growing team to meet program timelines. Help data scientists communicate complex information to a cross-functional audience. Basic Requirements PhD with 5+ years of industry experience or BS/MS with 15+ years of related experience. Additional Preferences Proven track record of successfully leading large-scale data science and AI initiatives across various business functions. Strong experience with machine learning algorithms, statistical modeling, and predictive analytics. Deep understanding of data engineering and data infrastructure, with a strong ability to collaborate with technical teams to build scalable solutions. Expertise in programming languages such as Python, R, SQL, and familiarity with big data technologies like Hadoop, Spark, and cloud platforms (e.g., AWS, GCP, Azure). Exceptional problem-solving and analytical thinking. Strong leadership, team-building, and mentoring skills. Excellent communication skills, with the ability to translate complex technical concepts into clear business strategies. Strong project management skills, with experience leading cross-functional teams and driving initiatives from concept to execution. 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 $193,500 - $338,800 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
    $95k-121k yearly est. Auto-Apply 9d ago
  • Manager, Catalyze360 IT Contracts & Business Operations

    Eli Lilly and Company 4.6company rating

    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 Lilly Catalyze360 is a comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars-Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLab-Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning. Job Summary The Manager of IT Contracts & Business Operations is responsible for negotiating fee-for-service IT contracts across the Lilly Catalyze360 organization. This role requires a proactive, self-driven individual with deep expertise in AI technologies and IT infrastructure and services who can navigate technical complexity while securing favorable commercial terms. The ideal candidate stays current on emerging AI/ML and other IT trends, understands their practical business applications, and can translate that knowledge into well-structured agreements that protect Lilly's interests while enabling innovation. This individual will provide contract matter expertise for IT engagements and collaborate with legal, finance, and technical stakeholders to structure agreements that balance business needs, risk mitigation, and cost optimization. The role has potential to expand into managing Business Operations IT pilots and systems implementations as well. Key Responsibilities * Negotiate complex contracts for a variety of Catalyze360 IT needs, including IT professional services, software license, software development, service level, SaaS/PaaS/IaaS, and AI/ML agreements as well as associated change orders * Serve as the primary interface between Business Operations and IT/business stakeholders, translating technical requirements into contractual terms and managing vendor relationships to ensure alignment with business objectives * Collaborate cross functionally with IT/business, legal, finance, and other stakeholders to structure IT agreements that balance business needs, risk mitigation, and cost optimization * Identify and mitigate business risks throughout the contracting process, including protecting sensitive confidential information and privacy * Manage multiple concurrent IT contract negotiations while monitoring performance and vendor compliance * Potential to oversee implementation, configuration, and ongoing management of Contract Lifecycle Management (CLM) and other systems to optimize contracting processes and ensure compliance * Potential to structure and oversee Business Operations pilot programs and promote adoption of successful pilot solutions Minimum Requirements * Education: Bachelor's degree from an accredited college or university * Experience: 3+ years of experience with a variety of IT contract negotiations (including IT professional services, software license, software development, service level, and SaaS agreements) in the biotechnology/ pharmaceutical or other regulated industry * Work Authorization: Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role. Additional Skills/Preferences * Experience * Demonstrated experience negotiating contracts for AI/ML applications across drug discovery and development * Prior experience designing and coordinating pilot programs, proof-of-concept initiatives, or technology evaluations * Experience with Contract Lifecycle Management (CLM) system implementation and optimization * Skills * Strong understanding of and fluency with IT architecture, cloud infrastructure, software development lifecycle, and enterprise technology solutions * Advanced expertise in Intellectual Property frameworks for AI/ML efforts * Deep understanding of IT security requirements, compliance frameworks including privacy regulations, and data governance in regulated industries * Ability to work through competing priorities with speed and agility in a highly collaborative environment with diverse stakeholders * Excellent communication skills with ability to engage diverse stakeholders including technical, legal, and finance team members * Strong analytical and problem-solving capabilities with strategic thinking and an entrepreneurial mindset Additional Information * Travel up to 10% US as needed for stakeholder engagement and vendor meetings. 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 $69,000 - $165,000 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
    $69k-165k yearly Auto-Apply 16d ago
  • Scientist 3, Microbiology

    Merck 4.6company rating

    Merck job in Bedford, MA

    Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: As a Scientist III in the Microbiological Sciences group, you will leverage your scientific and engineering expertise to develop, validate, and advance microbiological test systems that support product development and manufacturing within Process Solutions R&D. You will lead the design and implementation of robust bacterial ingress and retention testing methods, contribute to system automation initiatives, and collaborate cross-functionally to ensure scientific rigor, regulatory compliance, and product reliability. Your work will directly enable innovation in sterile filtration, contamination control, and microbial risk assessment-driving excellence in product quality, supply, and scientific leadership. Develop and execute bacterial ingress and retention studies for filtration and single-use systems. Design challenge models to evaluate system integrity and microbial barrier performance. Author study protocols, analyze data, and prepare technical reports. Collaborate with engineering and digitalization teams to automate bacterial retention testing systems. Lead system integration projects to modernize microbial testing platforms across R&D and manufacturing labs. Contribute to new equipment and test methods development aligned with regulatory standards (e.g., Annex 1, ASTM F838). Plan and execute method development and validation studies for microbiological assays. Support microbiological expertise in product/process changes, raw material qualification, and contamination control strategies. Who You Are: Minimum Qualifications: Bachelor's degree in Microbiology, Chemistry, Biomedical Engineering, Chemical Engineering, or other Life Science or Engineering discipline. 5+ years of experience in microbiological method development, bacterial retention/ingress testing, or bioprocess system validation. OR Master's Degree in Microbiology, Chemistry, Biomedical Engineering, Chemical Engineering, or other Life Science or Engineering discipline. 3+ years of experience in microbiological method development, bacterial retention/ingress testing, or bioprocess system validation. OR PhD in Microbiology, Chemistry, Biomedical Engineering, Chemical Engineering, or other Life Science or Engineering discipline. Preferred Qualifications: Experience in designing method development, bacterial retention/ingress testing, or bioprocess system validation. Strong understanding of sterile filtration, contamination control, and regulatory standards (Annex 1, ASTM, PDA TRs, etc.). Proficiency in data analysis, risk assessment, and technical documentation. Excellent collaboration, communication, and problem-solving skills. Experience with automated retention stands or development of custom bioprocess test rigs. Familiarity with cleanroom practices, BSL-2 testing environments, and digital data acquisition systems. Experience translating complex microbiological data into actionable design and process insights. Hands-on experience with microbial challenge testing and aseptic system design. Pay Range for this position: $110,000 to $135,000. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. RSREMD What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
    $110k-135k yearly 3d ago
  • Distinguished Scientist, Clinical Research, Thoracic Malignancies

    Merck 4.6company rating

    Merck job in Boston, MA

    Our Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards. The Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead, Oncology Global Clinical Development, has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of Thoracic Oncology. The Executive Director, PDT Lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders. Specifically, the Executive Director, PDT Lead may be responsible for: + Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications. + Developing clinical development strategies for investigational or marketed agents that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations. + Planning clinical trials (design, operational plans, settings) based on these clinical development strategies + Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed agents + Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications + Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds and support of business development assessments of external opportunities. + Provide support for other therapeutic areas regarding clinical issues related to oncology compounds. The Executive Director, PDT Lead may: + Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects. + Supervise the activities of entire Clinical Teams in the execution of clinical studies. + Will report to and work collaboratively with the Section Head to promote the development strategy of the company on the indication of interest. + Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, medical affairs and manufacturing to manage clinical development projects; and assist the Section Head in ensuring that appropriate Corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility. The Executive Director is responsible for maintaining a strong scientific fund of knowledge by: + Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies + Identification of scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs + Establishing communications with prominent clinical investigators in their field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs + Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility. To accomplish these goals, the Executive Director, PDT Lead may: + Author detailed development documents, presentations, budgets, and position papers for internal and external audiences + Facilitating collaborations with external researchers around the world + Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects. **Education:** M.D or M.D./Ph.D. **Required Experience and Skills:** + Must have experience in industry in the field of Thoracic Oncology + Minimum of 3 years of clinical medicine experience + Minimum of 5 years of industry experience in drug development + Demonstrated record of scientific scholarship and achievement + A proven track record in clinical medicine and background in biomedical research is essential + Strong interpersonal skills, as well as the ability to function in a team environment, are essential. **Preferred Experience and Skills:** + Board Certified or Eligible in Oncology (and/or Hematology) + Prior specific experience in clinical research and prior publication **Required Skills:** Clinical Development, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Trial Planning, Clinical Trials, Cross-Cultural Awareness, Cross-Functional Teamwork, Drug Development, Ethical Standards, Medical Research, Oncology, Pulmonology, Regulatory Requirements, Research Methodologies, Scientific Consulting, Scientific Leadership, Scientific Research, Strategic Leadership **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $310,900.00 - $489,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** **VISA Sponsorship:** **Travel Requirements:** **Flexible Work Arrangements:** Hybrid **Shift:** **Valid Driving License:** **Hazardous Material(s):** **Job Posting End Date:** 01/30/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381175
    $105k-154k yearly est. 17d ago

Learn more about Merck jobs

Most common locations at Merck