Boehringer Ingelheim jobs in Fremont, CA - 95 jobs
Principal Scientist, Biopharma Innovation & Digitalization
Boehringer Ingelheim GmbH 4.6
Boehringer Ingelheim GmbH job in Fremont, CA
A global biopharmaceutical company is looking for a Principal Scientist in Innovation Management. The role involves the development of upstream processes, oversight of biopharmaceutical production, and integration of digital tools in manufacturing. Candidates must have significant experience in biopharmaceutical manufacturing and possess strong leadership capabilities. This exciting opportunity advocates for collaboration, innovation, and a commitment to high-quality standards in a dynamic working environment.
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$134k-180k yearly est. 2d ago
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Specialist, MES MBR Designer, Fremont CA
Boehringer Ingelheim Group 4.6
Boehringer Ingelheim Group job in Fremont, CA
This position offers a base salary typically between (75,000) and (122,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.
Responsible for understand all the complexities of the BioMES system, lead the design of new types electronic batch record recipes, mentor junior staff on trouble shooting efforts within the BioMES system and managing and owning continuous improvement initiatives relative to BioMES. This position is also responsible for the overall business process and improvement topics relative to electronic records. This position is expected to understand the nuances of the highly complicated electronic system. This position utilizes LEAN tools to systematically evaluate information flow, create project plans and drive right first time success. The Specialist trains junior modelers to learn how to generate batch records, generates and refines batch record creation training materials, and develops the trouble shooting skills of the team. The specialist works with client groups (Process Engineers, Operations, Quality) to determine improvement opportunities within the scope of electronic batch records and leads the team to prioritize and implement said improvements. This role is required to work with industry experts to stay abreast of industry changes and expectations related to computer systems and electronic batch record design and to influence changes to software such that it continues to meet the needs of the business. This role requires a small amount of travel (1-2 trips/ year) The Specialist leads improvement teams, participates in project teams and works within BioPharma BioMES team to standardize business processes. The person within this role is the business process owner for BioMES business processes such as templates, review, etc. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
BioMES expert. Mentors modelers to learn and troubleshoot challenges within BioMES system.
Trains new modelers to develop GMP, consistent and streamlined batch records in BioMES. Leads team to create new batch record types and systematically evaluate information requirements.
Leads cross functional Fremont team to identify and implement business process improvements. This is realized through project management skills and cross functional team leadership.
Actively participate in the identification and implementation of manufacturing procedure improvements intended to optimize existing processes and ensure achievement of regulatory and safety requirements. Update GMP documentation as required.
Participate in BioMES user group meetings and bring influence software company (Werum) to address software improvements.
Standardize business processes across BioPharma. Local business process owner for BioMES business processes such as batch record templates, review processes, content requirements for batch records, etc.
Actively participate in troubleshooting and variable identification for specific processes or activities as assigned.
Assist IT to maintain a compliant, qualified and healthy MES system through systematic resolution of issues and communication with Werum to resolve system bugs.
Requirements
Requires a Bachelor’s degree from an accredited institution, preferably in a related field plus a minimum of four (4) to six (6) years’ experience in a GMP Pharmaceutical manufacturing environment.
In lieu of a Bachelor's degree, will consider an Associate's degree from an accredited institution, in a related field with a minimum of ten (10) years’ experience in a GMP Pharmaceutical manufacturing environment.
In lieu of a Bachelor's or Associate's degree, will consider a High school diploma/GED plus (12) years’ experience in a GMP in a Pharmaceutical manufacturing environment.
BioMES system expert
Drives continuous process improvements for BioMES batch record processes business processes.
Developing leader, able to technically understand complex manufacturing execution system.
Ability to transform/translate process information/design from process description into a BioMES Master Batch Record
Strong independent judgment and decision making abilities required.
Strong knowledge of relevant regulatory guidances.
Demonstrated problem-detection and problem-resolution skills required.
Strong conflict resolution and negotiation skills required.
Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
Must possess excellent verbal and written communication skills; good interpersonal skills.
IT experience preferred
Strong leadership skills
Strong ability to communicate
Strong ability to influence in a team environment and collaborate with peers.
To be qualified for this position must meet the following:
Physical Demands / Surroundings - Requires physical activity such as almost constant standing, walking, eyestrain, etc. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.
Visual Demands - Position requires constant use of computer terminals and routine / repetitive work.
Temperaments/Mental Requirements - The position requires concentration as errors might cause moderate to serious delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
Level of Proficiency - Experienced level subject matter proficiency required
Attendance / Schedule - The schedule is dependent on the shift hired. Attendance requirements are based on general attendance policies.
To remain in this position, employees:
Must obtain ' maintain qualifications, as required, to perform the assigned work.
Must understand, will be held accountable for and must adhere to all SOPs, company Policies and Procedures
Must adhere to proper technique, proper documentation practices, and all other aspects of the cGMP’s
Must maintain all training requirements and regularly checks the LOS training system in order to complete all required training on time.
Desired Skills, Experience and Abilities
Experience with manufacturing execution systems (electronic batch records). Experience working in multiple projects.
minimum of one year MBR Designer experience preferred
Project Management and/or Lean Six Sigma skills highly desired
$99k-144k yearly est. 60d+ ago
Global Study Director, Cell Therapy Trials
Astrazeneca 4.6
San Jose, CA job
A global biopharmaceutical company in California is seeking a Global Study Director to oversee groundbreaking clinical studies. You'll lead cross-functional teams, manage project deliverables, timelines, and ensure compliance with regulatory standards. The ideal candidate will have extensive experience in clinical trials, particularly in hematology and oncology, with strong project management skills. This role offers a competitive salary and benefits, emphasizing collaboration and innovation within a diverse workplace.
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$126k-161k yearly est. 5d ago
Senior Engineer, Process Engineering
Astrazeneca 4.6
Redwood City, CA job
Expertise in equipment and manufacturing process, capability to support multiple process areas
3+ years of leadership and project management skills; Lead executions of Manufacturing related engineering projects. Works on several different projects and prioritizes these projects with guidance
Proficiency in all of the following fields equipment, process/materials, maintenance, project delivery
Support investigations, owns CAPAs, and responsible or product impact assessment, and risk assessments related to manufacturing processes.
Lead solving activities to resolve critical issues, planned and unplanned activities, and anticipate future engineering developments within maintenance/process area
Designs studies, accomplishes experiments/protocols and perform data analysis. Develop and optimize processes within own area of process engineering
. • Track, trend, and analyze in-process data using statistical process control (SPC) methods. Monitor and improve process performance.
Share technical knowledge and expertise with personnel in AstraZeneca to aid technical developments within the organization.
Recommend and implement transformation/ continuous improvement initiatives within site with focus on cost saving and improvement of quality and efficiency.
Employ Good Engineering Practices to streamline project executions ;collaborates with multi-functional teams to solve problems
Provide mentorship and coaching to junior engineers, interns, and manufacturing technicians
Guide execution of processes (e.g., validation, qualification, operation, evaluation and troubleshooting of process deviations) within process engineering area.
Participate in communications with relevant internal teams (e.g., regulatory) for management of change control.
Guide and track compliance of own work and work of others with SHE and other applicable standards and regulations. Provide engineering solutions to manufacturing challenges and meet all safety, quality, supply and requirements. Develop contacts across a range of departments and external groups acting as engineering representative. Equipment Management
Prepare equipment for qualification activities, including but not limited to: TOP preparation and review, initial testing and qualification readiness
Handles production equipment. Maintain equipment maintenance strategies, and equipment lifecycle management
Lead/ guide planning, managing, and monitoring of major manufacturing and maintenance plan projects from concepts to implementation
Lead equipment specification, design, build, commissioning and qualification to meet technical/safety/ and business
Essential Requirements:
Bachelor's degree in Chemical or Mechanical Engineering
Minimum of 3 years relevant experience.
Breadth of experience to establish credibility with key stakeholders.
Industry experience in a GMP environment
Preferred Experience:
5 years of relevant experience
Large Capital project management and execution experience
Lean certification
Experience with automatic process controls
Root cause investigation training/ 6-simga
TPM experience
Experience with spray-drying technology
Experience with equipment maintenance
Experience with regulatory inspections and handling deviations
Experience working within cross-functional teams.
Has experience in change control, budget and project management, including a track record of driving continuous improvement initiatives.
Project management track record of delivering projects
Data Analysis tools (SQL, JMP, Minitab) , visual management tools (Powerbi, PowerApps)
The annual base pay for this position ranges from $97,372 - $146,058. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
22-Dec-2025
Closing Date
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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$97.4k-146.1k yearly 1d ago
Pharmaceutical Sales - Associate Territory Manager - Cardiometabolic Health
Eli Lilly and Company 4.6
Fremont, CA 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.
Position Territory:
Associate Territory Manager - Cardiometabolic Health - FremontCA CMH1_ 173597
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.
The Territory Manager will be accountable for account-based selling to health care providers (HCPs) who prescribe and influence the treatment for the disease states represented in the Lilly portfolio. This includes customers in multiple HCP specialties, as well as representatives in key hospital accounts. They will be viewed as a credible expert and resource supporting all medicines and appropriate brand patients.
The Territory Manager will be accountable for driving results by embracing Lilly's suite of models: Lilly Selling Model, Lilly Competency Model and Account Management Model to meet the needs of customers through strong execution. Territory Managers will drive consistent ways of working within the Regional Healthcare Market. They will build relationships with key customers to drive utilization and adoption of our medicines for the right patients. Specific responsibilities include the following:
BUSINESS OWNERSHIP
• Promotes the full portfolio of priority products with multiple HCP specialties.
• Understands the marketplace within the territory; evaluates and tailors the territory strategy to grow and own business outcomes.
• Navigates the ever-changing healthcare environment and payer landscape to increase understanding of accounts and be able to impact key stakeholders to become trusted partners.
• Utilizes appropriate business insight tools, data, and analytics to identify trends, priorities, opportunities, and potential obstacles.
• Implements and adopts new technologies, including the integration of AI company-approved tools and other analytical capabilities to streamline customer interactions.
• Identifies and advocates for new opportunities to enhance the customer experience.
• Models a growth mindset to create positive experiences.
SELLING SKILLS / CUSTOMER EXPERIENCE
• Embraces and uses the company's selling, competency and account management models to elevate performance and drive results.
• Demonstrates high learning agility to understand disease state, marketplace, clinical trials, and product label.
• Promotes the BU portfolio by planning for and engaging in patient-centered dialogues with customers.
EXECUTION / RESULTS
• Promotes across BU-portfolio and across HCP specialties, driving consistent ways of working within the Regional Health Care Market to meet customers' needs. Appropriately, fully utilizes the Virtual Medical Hub.
• Achieves targeted sales and execution metrics while adhering to company policies and procedures. • Owns the customer relationship for product promotion, on-label medical questions, and general market access. • Holds self-accountability for results and performance across all accounts, from individual HCPs to large health systems. • Builds and maintains relationships with both internal and external partners to foster trust and create collaborative success.
BASIC QUALIFICATIONS
• Bachelor's degree.
• Professional certification or license required to perform this position if required by a specific state.
• Valid US driver's license and acceptable driving record is required. • 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
• Demonstrated business ownership skills, selling/customer experience skills, and execution/results.
• Account based selling experience. Ability to identify and engage staff members in accounts.
• Strong learning agility, self-motivation, team focused, and emotionally intelligent.
• Bilingual skills as aligned with territory and customer needs.
• Residence within 30 miles of the territory boundary.
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
$63,000 - $151,800
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
$63k-151.8k yearly Auto-Apply 3d ago
Lead Technician- QA PAR (Day Shift)
Eli Lilly and Company 4.6
Concord, CA 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:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The Quality Assurance Floor Support Specialist is responsible for providing QA oversight to GMP operations. The role will provide QA support of the start-up and qualification of the Concord site. The QA Floor Support Specialist will demonstrate teamwork by collaborating cross functionally with various levels of the organization. As the project progresses, this role will transition to supporting and escalating issues from manufacturing to the site-based process team for one of the following manufacturing areas:
* Formulation and Equipment Preparation Processes
* Parenteral Filling (Pre-Filled Syringes)
* Automated and Semi-automated Visual Inspection
Responsibilities:
* Support on-the-floor manufacturing activities with routine presence in the assigned manufacturing area.
* Follow good documentation practices and compliance with site procedures.
* Review and approve GMP documentation such as electronic batch records, logbooks, etc.
* Support creation of Standard Operating Procedures and associated Forms, Tools and Training.
* Troubleshoot and provide support to resolve equipment alarms and other issues in quality systems such as Veeva and MES.
* Maintain open communications between cross functional teams and area leadership.
* Support the execution of inspection readiness activities including support of site self-inspections.
* Support project initiatives needed for the project and Quality function.
* Communicate any compliance issues associated with the project or site to Quality Management.
* Evaluate potential product quality impact for any GMP-related incident and support the investigation and assist with safety investigations.
Basic Requirements:
* High School diploma or equivalent
* Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
* Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills
* Strong attention to detail
* Ability to work independently with minimal supervision
* Proficiency with computer systems including Veeva, MES, Microsoft Programs
* Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals
* Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B paths or at R1 Level.
Additional Preferences:
* Associates or Bachelors degree in a science, engineering, computer, or pharmaceutical related field of study, preferred
* Previous experience with GMP manufacturing equipment prep, formulation, filling, and visual inspection
* Previous experience with Manufacturing Execution Systems (MES) or electronic batch records
* Previous technical writing experience
* Technical aptitude and ability to train and mentor other team members
Additional Information:
* Ability to work 12 hour shifts onsite on a rotating 2-2-3 schedule (not eligible for remote work)
* Overtime and off-shift support may be required
* May be required to respond to operational issues outside of core business hours and days
* May be subject to post-offer physical and vision exam
* Job is exposed to repetitive movements such as: Walking, Sitting, Bending, Twisting
* Must have ability to lift 30lbs
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
$28.84 - $46.54
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
$122k-152k yearly est. Auto-Apply 6d ago
Operator, Formulation (Day Shift)
Eli Lilly and Company 4.6
Concord, CA 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.
Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. Our 35,000 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 and embody our company values of Integrity, Excellence, and Respect for People
Position Description
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site.
If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity!
During the project phase, the Parenteral (PAR) Operators (Entry to Lead roles) will support start up activities required to bring the area into service which may include formulation, aseptic isolator barrier filling, and visual inspection. They will become the experts within their assigned area and educate their team in the proper operation of the facility. The Expert and Lead roles are expected to become the leaders for the PAR equipment and process and will lead the training of new staff. This position will require travel (2-4 week trips and/or 3-9 month short term assignments) domestically with the opportunity for travel internationally to collaborate, train with, and learn from sites who currently produce our medicines.
After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Senior and Lead Operators will coordinate daily activities to meet capacity plans while developing their own and our team's capabilities.
As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles.
Integrity
* Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
* Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals.
* Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.
Excellence
* Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor.
* Responsible for administering technical training and ensuring all operators are trained to perform tasks.
* Operate the equipment and perform activities as required to meet production schedule.
* Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs)
* Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
Respect for People
* Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas.
* Key liaison between operations and support functions.
Education, Experience, and Skills
* We have several levels open for Operator which are based on the experience and education you bring.
* Minimum education: High School Diploma or GED
* Ability to effectively communicate (electronically, written and verbal)
* Flexibility - the ability to troubleshoot and triage challenges
* Computer proficiency (desktop software, MS office).
* A valid driver's license
* Must pass a vision exam and be free of color blindness
* Must be equivalent to 20/20 correctable close vision acuity
Time Commitments and Work Authorization
* Must Pass a "fitness for duty" physical exam
* In operation, must have the ability to work 6am to 6pm on a 2-2-3 schedule
* Ability to work overtime as required
* Ability to wear safety equipment (glasses, shoes, gloves, etc.)
* Ability to work and gown in a cleanroom (Grade C, ISO 8) environment.
* Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Experience with, completion of, or understanding of:
* (Senior and Lead roles) Leadership and the ability to train / educate team members
* STEM degree or certifications
* Aseptic filling, single use assemblies, isolator technology.
* Automated, semi-automated, and/or manual inspection.
* Knowledge of current Good Manufacturing Practices (CGMPs)
* Experience in operations or manufacturing environments.
* Pharmaceutical, medical device or food processing industries
* Manufacturing Execution Systems and electronic batch release.
* Continuous improvement (Lean, Six Sigma methodologies)
* Highly automated equipment (inspection, packaging, filling, assembly, etc)
* SAP, Electronic Batch Records
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
$17.30 - $38.08
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
$79k-105k yearly est. Auto-Apply 44d ago
Associate Director, Statistics
Allergan 4.8
San Francisco, CA job
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
TheAssociate Director, Statistics - Oncology provides statistical leadership for clinical development and life‑cycle management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs (GMA). The Associate Director works in partnership with experts in multiple disciplines to advance medicines to our patients.
This role will work a hybrid schedule in one of the AbbVie locations:
Lake County, IL
South San Francisco, CA
Responsibilities
Provide statistical support for one or more clinical development projects through own efforts or those of a team. Lead/develop statistical strategy for project development and regulatory submission.
Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans.
Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, and GMA, etc.) to create development strategies for assigned projects.
Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately.
Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.
Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing collaborators. Build external scientific connections which foster professional development and promote the reputation of the Statistics Department.
Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software to ensure compliance with SOPs and regulatory requirements.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
Qualifications
MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field.
High degree of technical competence and excellent communication skills, both oral and written.
Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others.
Able to manage project timeline and quality of deliverables.
Able to build strong relationship with peers and cross‑functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo.
Have strong leadership skills and experience in working/managing cross‑cultural or overseas teams.
Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life‑cycle management in the regulated environment.
(SSG) Experience leading safety‑related projects (eg, ISS, benefit‑risk assessment, signal detection).
(GMA Stat) Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Knowledge of methodologies for confounding control and bias minimization in observational studies preferred.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short‑term incentive programs.
This job is eligible to participate in our long‑term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit *************************************************************************
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************
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$146k-190k yearly est. 4d ago
Operator, Aseptic Filling (Night Shift)
Eli Lilly and Company 4.6
Concord, CA 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
For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.
Position Description
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site.
If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity!
During the project phase, the Parenteral (PAR) Operators (Entry to Expert roles) will support start up activities required to bring the area into service which may include formulation, aseptic isolator barrier filling, and visual inspection. They will become the experts within their assigned area and educate their team in the proper operation of the facility.
After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Operators will support daily activities to meet capacity plans while developing their own and our team's capabilities.
As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles.
Key Values / Objectives
Integrity
* Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
* Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals.
* Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.
Excellence
* Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor.
* Responsible for administering technical training and ensuring all operators are trained to perform tasks.
* Operate the equipment and perform activities as required to meet production schedule.
* Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs)
* Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
Respect for People
* Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas.
* Key liaison between operations and support functions.
Basic Qualifications/Requirements:
Time Commitments and Work Authorization
* Minimum education: High School Diploma or GED
* A valid drivers license
* Must Pass a "fitness for duty" physical exam
* Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
* Must pass a vision exam and be free of color blindness
* Must be equivalent to 20/20 correctable close vision acuity
* Must be able to work a 2-2-3 schedule
Additional skills/preferences:
Experience with, completion of, or understanding of:
* We have several levels open for Operator which are based on the experience and education you bring.
* Ability to work overtime as required
* Ability to wear safety equipment (glasses, shoes, gloves, etc)
* Ability to work and gown in a cleanroom (Grade C, ISO 8) environment.
* Ability to participate in professional development opportunities (team coursework such as classes through RCCC)
* Ability to effectively communicate (electronically, written and verbal)
* Flexibility - the ability to troubleshoot and triage challenges
* Computer proficiency (desktop software, MS office).
* Leadership and the ability to train / educate team members
* STEM degree or certifications
* Aseptic filling, single use assemblies, isolator technology.
* Automated, semi-automated, and/or manual inspection.
* Knowledge of current Good Manufacturing Practices (CGMPs)
* Experience in operations or manufacturing environments.
* Pharmaceutical, medical device or food processing industries
* Manufacturing Execution Systems and electronic batch release.
* Continuous improvement (Lean, Six Sigma methodologies)
* Highly automated equipment (inspection, packaging, filling, assembly, etc)
* SAP, Electronic Batch Records
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
$17.30 - $34.38
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
$38k-44k yearly est. Auto-Apply 60d+ ago
Warehouse Technician
Eli Lilly and Company 4.6
Concord, CA 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.
Position Description: Receiving, storage, and shipping of raw materials and packaging components in support of the Lilly Concord manufacturing site. Ensure materials are available and on hand for weekly production operations and ensure inventory quantities are accurate. Requirement to handle and process materials in inventory system always following cGMP processes. The position reports to the Warehouse Supervisor.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Responsibilities:
* Accurate receiving and storage of manufacturing components from outside vendors and other Lilly sites. Shipping of orders to internal and external Lilly customers.
* Unloading / loading of materials at docks, receiving of materials, storage of material in appropriate storage zones, preparation and shipping to customer orders, order processing in warehouse inventory system, cycle counting.
* Follow all safety requirements and procedures. Routinely inspects area for health and safety issues. Assist with implementation of countermeasures from safety incident investigations. Work with area Supervisor, Warehouse Specialists, and safety representatives to implement safety projects.
* Follow all cGMP, and other regulatory requirements. Participate in quality initiatives and audits. Compliance to FDA, EMEA, DEA, OSHA, IDEM, EPA and other applicable regulations.
* Meet appropriate goals for performance improvement as defined by area Leadership.
* Execute inventory transactions in a timely fashion.
* Provide key customers with raw materials and components on time and in full.
* Maintain learning plan at 100% current.
* Follow and execute policies and procedures impacting warehouse activities.
* Maintain a safe work environment, working safely and accountable for supporting all HSE corporate and site goals.
* Perform other duties as assigned by the supervisors.
Basic Requirements (Education, Experience, Training):
We have several levels open for Warehouse technicians which are based on the experience and education you bring.
* Minimum education: High School Diploma or GED
* Certified to operate assigned powered industrial trucks or ability to obtain certification within 3 months of employment start.
Additional Preferences:
* Ability to effectively communicate (electronically, written and verbal)
* Flexibility - the ability to troubleshoot and triage challenges.
* Ability to use Computer tools (desktop, MS Office) and electronic tools (Scan guns and tablets).
* Ability to pick-up / move up to 50-pound containers.
* Strong interpersonal and communication skills
* Demonstrated ability to work as a team across various areas.
* Solid understanding of quality and corporate policies
* Exposure to SAP/EWM preferred.
* Solid understanding of the importance of and basic requirements of regulatory agencies such as the FDA, EMEA, OSHA and EPA.
* Demonstrated solid judgment and initiative.
* Ability to use technology tools such as Scan guns, tablets and laptops strongly preferred.
* Enthusiastic, positive attitude, flexible and willing to work overtime.
* Proactive and self-motivated to support team initiatives and in solving business problems.
* Ability to perform multiple tasks at the same time and make decisions regarding prioritization.
* Previous experience with materials handling and inventory management systems.
* Previous warehouse/logistics experience in a cGMP environment.
Additional Information:
* Ability to work overtime, weekends, and off shifts as needed.
* Tasks may require handling hazardous materials following safety procedures.
This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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
$17.30 - $38.08
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
$35k-41k yearly est. Auto-Apply 15d ago
SR Specialist SQM, Fremont CA
Boehringer Ingelheim Group 4.6
Boehringer Ingelheim Group job in Fremont, CA
The Sr Specialist, SQM role offers a base salary typically between (90,000) and (147,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits please click here.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The basic purpose of this role is to perform active quality management and quality oversight of the Biopharma GxP relevant material/service suppliers, including services of clinical and commercial GMP contract manufacturing organizations (CMOs) and contract laboratory organizations (CLOs).
The Senior Specialist, Supplier Quality Management (SQM) will execute SOPs and processes that ensure the procured materials and services are aligned with the expectations of Boehringer Ingelheim Quality Systems, Quality Assurance Agreements (QAAs), and Clients' requirements and compliant with health agencies' expectations. This role will actively work on resolving issues that arise from the job execution in accordance with the approved SOPs.
This is an onsite position with flexibility.
Duties & Responsibilities
Participates in creation of the team standard operating procedures and uses the corporation's applicable computerized system (e.g., Go-Track) to execute the assigned tasks that may include:
Quality management and oversight of the GxP relevant materials, service, and suppliers (including CMOs and CLOs), addressing the different phases of the supplier life cycle (e.g., audits).
Generation, review, negotiation and maintenance of Quality Assurance Agreements with CMOs, CLOs and suppliers. Note: this includes other BI sites inter-company QAAs.
Supplier/CMO/ CLO selections and (re)qualification processes, manufacturing and analytical, technical transfers to the CMOs/CLOs and material certifications.
Can be delegated to act as the quality responsible person, first escalation point and source of quality guidance (e.g., material review board decision-making) to resolve quality issues triggered by interactions with the assigned suppliers or use of their materials and services.
Escalates issues to the immediate supervisor (and to other stakeholders as per the defined and approved escalation policies, e.g., reporting to the global functions, Supplier with the issue process) to resolve conflicts promptly and minimize risks to Boehringer Ingelheim.
Handles and investigates deviations from established procedures per the applicable procedures and work cross-functionally with other relevant stakeholders to provide adequate and timely investigations.
Be qualified in the investigation process.
Handles the assigned changes (e.g., supplier change notifications, process changes at the CMO) potentially impacting product quality or regulatory compliance per the applicable procedure.
Acts as a subject matter experts/MSO at the site who is knowledgeable and continually trained on the applicable local and global procedures.
Drives integration of BIFI with global platforms and ensures site representation in the relevant global forums and meetings.
Communicates BIFI perspective to those forums and influences the global functions and MSOs to establish procedures that BIFI can practically implement and comply with.
Ensures active engagement in identifying, sharing and adopting shared practices between Boehringer Ingelheim sites/offices.
Implements and supports business processes for continuous improvements.
Establishes evaluation measures to monitor the performance of CMOs, CLOs, services, materials and suppliers (e.g., establishing key performance indicators and their follow-up methods to ensure meeting the KPI targets or thresholds, meeting in person with the CMOs, CLOs and suppliers at their locations to monitor performance and drive improvements, ensuring strict adherence to the established timelines in the QAAs).
Performs necessary trending and escalations to the immediate supervisor. Introduces processes, systems corrections, and improvements (e.g., CMO and CLO development and proactive risk reduction measures).
Periodically reports the status to the site's appropriate review forums that may include site senior leadership personnel.
Performs additional duties as assigned within the scope of the quality function at Boehringer Ingelheim Fremont (e.g., prepares documentation supporting regulatory submissions, actively participates in site readiness activities for audits and inspections, and supports the compliance function during such audits).
Represents BIFI during audits and inspections and defends BIFI practices, positions and decisions whenever challenged.
Requirements
Bachelor's Degree in a scientific / technical discipline.
Minimum five (5) years' experience in a life sciences or closely related industry.
Systems skills (e.g., SAP / GoTrack); Experience in supply chain/supplier and material quality evaluation and design.
Experience managing within a high-speed customer-oriented environment.
Knowledge of all relevant industry standards and regulatory expectations.
Ability and willingness to continuously improve local and global standards and drive towards improved compliance and quality.
Excellent oral and written communication skills.
Ability to motivate and mobilize staff.
Must exercise rapid learning ability, attention to detail, excellent computer skills, team player, organized, analytical thinker with high energy and self-motivation.
Ability to read, develop, and understand procedures and other controlled documents.
Must have well-developed interpersonal skills to establish highly functional relationships with diverse personalities cross-functionally.
Demonstrated proficiency in MS Office programs and associated computer programs.
Ability to work in a team environment.
Eligibility Requirements:
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
$123k-162k yearly est. 60d+ ago
ExploR&D Clinical Program Lead
Eli Lilly and Company 4.6
San Francisco, CA 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.
Overview
Lilly Catalyze360 is Lilly's 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 TuneLabs-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.
Lilly ExploR&D is a team of drug discovery and development experts who partner with biotechs from discovery through clinical proof-of-concept, putting Lilly's industry-leading capabilities behind their missions. We provide flexible support-from strategic consulting to full program execution-making it faster, easier, and more capital-efficient for innovators to transform bold science into life-changing medicines.
Job Summary
The ExploR&D Program Lead (EPL) serves as the single point of accountability for external collaboration projects within Lilly's ExploR&D organization. The role focuses on defining strategy, developing aggressive timelines and budgets, and leading cross-functional teams from Catalyze360 and Lilly Research Laboratories to deliver high-quality results on time and on budget. Reporting within the Catalyze-360 Project Management structure, the EPL leads diverse, cross-functional teams to deliver innovation by pioneering novel science and technologies that advance future medicines and transform R&D collaboration models.
Key Responsibilities
Team Leadership and Project Management
Lead multiple collaboration teams comprised of ExploR&D personnel, LRL subject matter experts and external biotech collaborators.
Create a high-performing team with a culture of trust, autonomy, agency, collaboration, and inclusion.
Deliver projects ‘on time, on budget', and within scope from discovery/pre-clinical development through clinical proof-of-concept using contemporary project management tools and approaches.
Scientific and Technical Leadership
Identify and synthesize relevant, technical information from a variety of sources including scientific literature, internal and external subject matter experts, and experimental or trial data to address key questions and guide study design and program strategy.
Provide and critically evaluate content within critical documents (e.g., Investigator Brochures, Risk Profiles, Study Protocols, Study Reports, Regulatory and Ethical filings and updates, Investigator updates, etc.).
Serve as the ExploR&D scientific leader responsible for rationale, integration of cross-functional data, synthesis of the risk/benefit profile, strategic conclusions, and designs to drive data-driven decision making.
Collaboration and Relationship Management:
Serve as primary liaison between Lilly and external biotech collaborators, fostering strong relationships, transparent communication and ensuring alignment on project goals.
Anticipate and resolve barriers to success by identifying potential roadblocks early, offering innovative solutions, and ensuring that collaboration programs are executed with excellence.
Create a ‘partner of choice' experience accounting for partner's goals and priorities, optimizing strategic plans with the spirit of an entrepreneurial drug developer to enable stakeholder decision-making and value-creation.
Operational Excellence and Process Improvement:
Contribute to diligence and workplan development that optimize outcomes for Lilly and external collaborators.
Drive operational excellence in program management by identifying and implementing process improvements that enhance the efficiency and effectiveness of external collaborations.
Basic Qualifications/Requirements
Education:
Advanced graduate degree (PhD, PharmD, or Masters) in a health-related, scientific or engineering field
Experience:
10+ years of work experience in the pharmaceutical industry including preclinical-translational sciences and/or clinical drug development across therapeutic modalities such as cell and gene, antibodies, peptides, oligonucleotides, vaccines, and small molecules.
Additional Skills/Preferences
Fluent Mandarin speaking and writing skills.
Prior experience managing external collaborations with proven track record of overseeing complex, cross-functional and external partnering projects.
Demonstrated ability to lead and influence teams in a matrixed environment, driving collaboration across diverse functions and geographies.
Exceptional verbal and written communication skills, with ability to clearly articulate project goals, strategies, and results to both internal and external stakeholders.
Demonstrated ability to anticipate challenges, diagnose root causes, and implement creative solutions that drive project success.
Strong intuition for business, with a deep understanding of asset strategy, portfolio management, and the broader pharmaceutical landscape.
Practical experience or certification in project management.
Intellectual agility to quickly adapt to changing circumstances, learn from past experiences, and apply learnings to new situations.
Strong ability to think with a portfolio-level mentality, ensuring that individual program decisions align with the overall goals of ExploR&D and Catalyze360.
Additional Information
Location: San Francisco, CA
Travel up to 25%
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
$187,500 - $275,000
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
$187.5k-275k yearly Auto-Apply 60d+ ago
Maintenance Technician - Night Shift
Eli Lilly and Company 4.6
Concord, CA 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.
Quick Benefits Overview:
* Medical, Dental, Vision, Prescription benefits are effective on your first day of employment
* Paid vacation- starting annually at 120 hours (prorated based on start date)
* Shift Bonus for Weekend hours
* Sign-on bonus
For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.
Responsibilities:
The focus of the Maintenance Technician - Night Shift is to provide maintenance expertise to service, repair, and maintain process and utility other pharmaceutical manufacturing equipment currently in service.
The Maintenance Technician - Night Shift is expected to understand the needs and requirements of the customer (Operations); must be able to work effectively with customers, handle customer questions with tact and understanding while displaying good customer service.
Key Objectives/Deliverables:
* This role is expected to improve equipment uptime, line efficiency, and increase overall equipment effectiveness in a production environment by condition monitoring, troubleshooting, and assisting in engineering changes.
* Must possess a good mechanical aptitude to troubleshoot and repair equipment while, following departmental rules and regulations.
* Must be willing to work with safety as a primary focus and abide by applicable safety procedures and practices.
* Troubleshoot the root causes of machine problems (e.g., excessive vibration or temperature, bearing failures, abnormal noises, and poor performance).
* Perform repairs and overhaul equipment (e.g., gear boxes, pumps, blowers, fans and drives) to include disassembly, setting tolerances, aligning, resetting timing (e.g., air compressors, vacuum pumps)
* Setup equipment to design specifications (e.g., timing, leveling, alignment)
* Operate precision alignment equipment (e.g., Roma-align, lasers, etc.)
* Must have the ability to quickly and accurately diagnose the root cause of a problem and implement the proper corrective actions to minimize downtime.
* Must accurately document the actions taken to repair the equipment in the CMMS program.
* Willing to assist in areas outside of their primary responsibility and learn other skills, as required
Basic Qualifications:
* High school diploma/GED
* Minimum 2 Years of Maintenance
* Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
* Must satisfy background check and drug screening requirements.
Additional Skills/Preferences:
* Must be able to speak, read and write English at a sufficient level to communicate technical and business information effectively.
* Must be able to effectively use business software programs, such as, Maximo, Microsoft Outlook, Microsoft Office Suite and other required software programs.
* Must be able to effectively work in a team environment.
* Physical considerations include the ability to work with or around equipment, climb ladders and stairs and use PPE (Personal Protective Equipment). He/she may be exposed to harsh weather conditions as part of the job.
* Good, all-around hands-on experience with repair of equipment.
* Use basic trouble shooting equipment such as multi-meters, calipers ect.
Additional Information:
* Overtime may be required during shutdowns, emergency situations, or periods of heavy workloads.
* The Maintenance Technician - Night Shift will work in and around potentially dangerous and hazardous equipment, powders, liquids and gases. Safety is paramount for this position.
* Night shift role. Will transition to a night shift 12-hr 2-2-3 schedule in the future. For the training period, it will be a day shift role.
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
$21.27 - $41.25
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
$71k-101k yearly est. Auto-Apply 33d ago
AD, Process & Cleaning Validation, Fremont CA
Boehringer Ingelheim 4.6
Boehringer Ingelheim job in Fremont, CA
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Associate Director, Process and Cleaning Validation leads the combined Process Validation and Cleaning Validation programs for US BioPharma's multi-product Drug Substance and Drug Product manufacturing facilities. This role provides strategic oversight and technical leadership for validation activities throughout the product lifecycle - from new product introduction (NPI), clinical, PPQ, and commercial manufacturing, through ongoing lifecycle management, periodic review, and revalidation. The position ensures robust, compliant, and efficient validation processes, drives continuous improvement, and maintains audit readiness, while collaborating cross-functionally to support site and corporate objectives.
Duties & Responsibilities
Validation Program Leadership
Owns and governs the Process Validation, Cleaning Validation, Cleaning Verification, Clean Hold, Control Strategy, Media Fill, Transport Validation, Continuous Process Verification, and Revalidation programs for the Fremont site
Develops and implements validation strategies in alignment with global teams, regulatory expectations, and industry best practices
Coordinates cross-functional efforts to plan, prepare and execute Process Performance Qualifications (PPQs). Manages resources and ensure timely completion of deliverables for PPQ & BLA
Accountable for US BioPharma's Control Strategy and Continued Process Verification programs from PPQ through product life cycle. Responsible for coordinating cross-functional revision efforts and maintaining the program in an audit ready state
Maintains validation programs and documentation in an audit-ready state, ensuring successful outcomes during health authority inspections, corporate audits, and client audits
Technical Oversight
Leads risk assessments, cycle development, stage gate management, protocol preparation and execution, verification, and periodic review for both process and cleaning validation
Ensures validation lifecycle management of manufacturing processes, including trending, gap closure, and continuous improvement hroughout the commercial production of Boehringer internal and client products
Champions simplification and optimization projects to increase compliance and efficiency.
Cross-Functional Collaboration & People Leadership
Works closely with Engineering, Technology, Manufacturing, CPT, Quality, and Compliance to troubleshoot and resolve validation challenges, investigate deviations, and drive improvements
Leads and supports cross-functional project teams for new product introductions and program improvements
Manages and develops a team of validation SMEs and staff, providing coaching, technical guidance, performance management, and career development
•Implements resource planning tools to project staffing needs and manage costs
Audit Readiness and Regulatory Representation
Develops audit strategies and represents the site in client and regulatory agency meetings, defending validation programs and outcomes
Participates in interactions with governmental agencies/regulators, external auditors and clients
Requirements
Bachelor's degree in Life Sciences, Chemical Engineering, Biotechnology, Biochemical Engineering, Biomedical Engineering, Biology, Chemistry, or related field. Master's or PhD preferred
8+ years (Bachelor's) or 6+ years (Master's) in pharmaceutical industry with direct cGMP experience; 2+ years managing/directing people or projects (Cleaning Validation)
Experience in interpreting and implementing validation standards across functional areas. Proven ability in applying creative methodologies that are compliant with regulatory expectations
Independent decision-making, ability to think conceptually and understand impact of decisions critical to product quality
Demonstrate initiative and flexibility in problem solving, providing risk-based solutions
Experience leading people and/or projects with history of achieving results and outstanding outcomes
Ability to work as part of high performing teams, collaborate effectively with staff at all levels, and establish highly functional relationships with diverse internal and external stakeholders
Advanced knowledge of cGMP, regulatory compliance, and validation standards
Excellent verbal and written communication skills; strong interpersonal skills
Lean/Six Sigma or business process excellence experience preferred
Eligibility Requirements:
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Compensation Data
This position offers a base salary typically between ($140,000) and ($222,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. Please reach out Talent Acquisition or your HR Business Partner for more information.
$38k-48k yearly est. 2d ago
Director - Immunology Research
Eli Lilly and Company 4.6
San Francisco, CA job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
We are a leading biopharma company dedicated to advancing therapies that extend healthspan and combat age-related diseases. We are seeking a highly motivated scientist to join our research team to spearhead efforts focused on immune aging and rejuvenation. In this role, you will drive cutting-edge research to identify and develop novel interventions, using any modality that is appropriate for the indication, to restore immune homeostasis, mitigate inflammaging and improve organ function. This position offers the opportunity to pioneer transformative therapies to ameliorate prevalent and debilitating conditions in the aging population, with a focus grounded in Immunology. The individual will have the opportunity to build and manage a research team supporting immune-aging projects and to provide cross-functional leadership through larger collaborative efforts.
Responsibilities
• Design and execute preclinical studies to investigate mechanisms underlying immune senescence, including but not limited to age-related hematopoietic stem cell (HSC) dysfunction, telomere attrition, senescence-associated phenotypes, and T-cell exhaustion.
• Develop rejuvenation/reprogramming strategies to revitalize hemopoietic and non-immune, parenchymal cells of interest in immune and age-related disorders.
• Utilize advanced techniques in cytometry, ‘omics and hi-dimensional datasets to identify targetable nodes for intervention. Use appropriate
in vitro, in vivo and ex vivo
models to assess immune aging phenotypes of interest.
• Collaborate with stakeholders in Immunology and other therapeutic areas to cross-functionally lead and develop research findings into future clinical candidates.
• Prepare and present research findings at internal meetings, scientific conferences, and in peer-reviewed publications.
• Stay abreast of emerging advances in the field to inform strategic decisions and help assess external opportunities as needed.
• Contribute to IP filings, and regulatory documentation as needed.
• Recruit and train a small team to scale research efforts.
Basic Qualifications/Requirements:
• PhD in Immunology, Cell Biology, Developmental Biology, or a related field; Postdoctoral experience in aging biology or rejuvenation is required.
• 5+ years of hands-on research experience in academia, biotech, or pharma, with a proven track record related to immune aging/senescence research.
Additional Skills/Preferences:
• Demonstrated expertise in molecular mechanisms of immune senescence, including inflammaging, stem cell exhaustion, and therapeutic interventions
• Familiarity with landscape of immune aging research activities including but not limited to academic labs, biotechnology companies, and large pharma.
• Strong publication record in high-impact journals with first- or senior-author contributions.
• Proficiency in experimental design, data analysis and statistical methods.
• Excellent communication skills, with the ability to convey complex scientific concepts to diverse audiences.
• Experience with in vivo models of aging (e.g., progeroid mice, humanized models) and translational strategies for rejuvenation therapies.
• Advanced knowledge of stem cell rejuvenation techniques, epigenetic reprogramming and delivery systems.
• Prior experience leading a cross-functional team and/or managing others.
• Understanding of the unique regulatory hurdles in regeneration and aging-related therapeutics.
Additional Information:
Travel: Estimated ~20%
Work Environment: Position is based in South San Francisco, CA
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
$163,500 - $281,600
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
$163.5k-281.6k yearly Auto-Apply 60d+ ago
Rheumatology Sales Consultant I/II/Sr. - San Francisco, CA
Boehringer Ingelheim 4.6
Boehringer Ingelheim job in San Francisco, CA
The Rheumatology Sales Consultant is responsible for implementing the Rheumatology sales and marketing plans to assure maximum distribution and market penetration of BIPI ILD products within BIPI guidelines, policies and directives. The Rheumatology Sales Consultant will conduct their business with key clinics and appropriate targeted Rheumatologist Clinicians and Allied Healthcare Professionals. The incumbent will have additional responsibilities for sales activities in teaching and community hospitals, federal and military hospitals. The Rheumatology Sales Consultant will manage a geography that may require overnight travel and occasional night and weekend meeting responsibilities.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides an opportunity for all employees to collaborate internationally, offering visibility and the opportunity to directly contribute to the company's success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
Maintains and utilizes product knowledge and highly effective selling skills in order to influence targeted health care professionals to support the use of BIPI promoted products. Executes brand strategies and business plans to ensure a consistent company sales and marketing message.
Establishes and maintains effective communication/cooperation/coordination with internal BIPI employees.
Develops clinic and customer pre-call plans to meet health care professionals' (HCP) and account needs. Builds valued discussion around HCP needs and opportunities. Fosters HCP network development and communication. Has accurate and timely follow-up discussions with HCP. Uses appropriate BIPI sales training techniques, supports and encourages exchange of scientific knowledge and dialogue thereby providing enhanced value and trust to the HCP through facilitation of patient management and decision-making process.
Identifies key business needs and activities, establishes business plans to address territory business needs and actively involves Sr. Associate Director, Clinical Educator, Payer Relations Managers, and other BI internal support personnel in the development, management and accomplishment of business strategies, plans and opportunities.
Analyzes territory information to optimize HCP calls. Monitors and effectively reacts to local market conditions for changes that impact business.
Develops plans to maximize Regional and National Speaker and other regional sales and marketing programs. Adjusts implementation plans on a regular basis (speaker development and management, advocate development, etc.). Creates opportunities that meet both territory and brand tactics.
Utilizes sales data and supporting analysis to plan activity, monitors literature use, and maintains account and HCP records. Completes all administrative responsibilities in a timely fashion as directed by management. Successfully completes all sales training requirements.
Identifies and develops Regional and National thought leaders, innovators and advocates to support BIPI products. Provides appropriate feedback and follow-up to speakers and attendees. Develops realistic plans to develop speakers and thought leaders. Initiates contacts and network-building among advocates and HCPs.
Manages programs and budgets to stay within BI standards. Determines how to efficiently and effectively utilize Regional and National speakers and company resources by proactively working with Sr. Associate Director and Key Account Manager.
Performs all Company business in accordance with all regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community.
Provides consistent, timely and complete administrative duties and responsibilities. All expense reports, call reports, and communications are completed effectively and on time. Additionally, accepts responsibility and ownership of personal development while working closely with his/her Sr. Associate Director. Develops a personal development plan and ensures twice annual review with Sr. Associate Director.
Demonstrates a complete knowledge of BIPI products and related marketplace, effective translation of product knowledge into the sales presentation and is customer focused with a priority directed towards providing solutions-based customer interactions. Encourages and receives requests from customers for expert technical information outside of standard visits thereby developing trust and subsequent value with customers.
Requirements
Candidates will be hired at the level commensurate with experience and/or skills.
Rheumatology Sales Consultant I
Bachelor's Degree required.
Minimum of 3 years of successful pharmaceutical sales experience required; 2+ years of Specialty/Rheumatology experience preferred.
Strong communications skills are required to perform the job satisfactorily.
Ability to travel with overnights and attendance at some weekend programs.
Valid Driver's License and acceptable driving record.
Proficiency in Excel, Word, Outlook, and any other relevant applications.
Strong communications skills are required to perform the job satisfactorily.
Ability to translate key scientific information supporting product, competitors, science and marketplace to a broad range of customers.
COMPENSATION DATA: The base salary range for Rheumatology Sales Consultant I is $95,000 to $153,100. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law.
Rheumatology Sales Consultant II
Bachelor's Degree required.
Minimum of 5 years of successful pharmaceutical sales experience with a minimum of 3 years Specialty/Rheumatology experience required.
Strong communications skills are required to perform the job satisfactorily.
Ability to travel with overnights and attendance at some weekend programs.
Valid Driver's License and acceptable driving record.
Proficiency in Excel, Word, Outlook, and any other relevant applications.
Strong communications skills are required to perform the job satisfactorily.
Ability to translate key scientific information supporting product, competitors, science and marketplace to a broad range of customers.
COMPENSATION DATA: The base salary range for Rheumatology Sales Consultant II is $110,000 to $178,100. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law.
Requirements (continued)
Sr. Rheumatology Sales Consultant
Bachelor's Degree required.
Minimum of 7-10 years of successful pharmaceutical sales experience with a minimum of 5-7 years Specialty/Rheumatology experience required.
Track record of working within a high performing team and a cross functional matrix environment.
Excellent communications, objective setting, and influencing skills.
Requires at least 1 year prior experience demonstrating account management, leveraging HUB services, collaborating with clinical educators and specialty pharmacies, supporting reimbursement navigation, working individually outside a "pod" structure, fostering market development, regional Key External Expert (KEE) engagement & relationship management, linking KEEs with appropriate internal stakeholders, fluency in the inner networking and navigation of teaching institutions.
Ability to travel with overnights and attendance at some weekend programs.
Valid Driver's License and acceptable driving record.
Proficiency in Excel, Word, Outlook, and any other relevant applications.
Strong communications skills are required to perform the job satisfactorily.
Ability to translate key scientific information supporting product, competitors, science and marketplace to a broad range of customers.
COMPENSATION DATA: The base salary range for Sr. Rheumatology Sales Consultant is $125,000 to $200,000. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law.
Eligibility Requirements:
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
$95k-153.1k yearly 2d ago
Scientist, Predictive Biology and AI
Bristol Myers Squibb 4.6
Brisbane, CA 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.
Scientist, Predictive Biology and AI
LOCATION
Seattle, Brisbane CA, San Diego CA, Cambridge MA, Princeton NJ
Overview
The Predictive Biology and AI (PBAI) team within BMS Research develops and applies cutting-edge methods to address patient needs and answer fundamental questions in Oncology, Neuroscience, and other application areas. We work closely with our wetlab partners to both test and deliver our predictions into the pipeline as well as integrate the data they generate into our models. We seek a collaborative AI expert possessing skills spanning machine learning and statistics as well as a passion for addressing unmet patient needs. The successful candidate will thoughtfully evaluate and adapt state-of-the-art AI models and techniques to challenges in cell engineering and target discovery. The role offers the opportunity to impact directly the delivery of truly transformational and life-changing therapies in key diseases of unmet medical need.
Responsibilities
* Apply, adapt, and in some cases create multi-modal foundation models such as large language models (LLMs), diffusion models, and encoder architectures to answer biological domain-specific questions
* Address real-world biological modeling challenges such as data sparsity, class imbalance, noise, experimental bias, and heterogeneity of effects
* Thoughtful model evaluation that incorporates appropriate benchmarks, statistical tests, and problem understanding to support technical and business decisions
* Work in close collaboration with partners across the organization including wet-lab scientists, Research IT, and other computational scientists to broaden the impact of AI developments
* Maintain and share up-to-date knowledge of modern advances in the field, including presenting work at public conferences
Basic Qualifications
* Bachelor's Degree 5+ years of academic / industry experience
* Or Master's Degree 3+ years of academic / industry experience
* Or PhD No experience required
Preferred Qualifications
* A Ph.D. with 0+ years industry research experience or an M.S. with 3+ years industry research experience in computer science, statistics, computational biology, or another quantitative field
* Expert-level understanding of and experience using deep learning tools and approaches (transformer-based encoders/decoders, LLMs, reinforcement learning, etc.) as demonstrated through publications or projects
* Hands-on experience leading the building and scaling of deep learning training pipelines on multi-GPU computational infrastructure using PyTorch, Huggingface, and/or other tools
* Knowledge of or the ability to learn biological concepts and data types, including the ability to work and communicate effectively with biologists
* Excellent verbal and written communication skills. Fluent verbal and written English language skills prerequisite
* Experience building agentic workflows is a plus
* Prior experience in pharmaceutical application areas is a plus
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:
Brisbane - CA - US: $141,150 - $171,042
Cambridge Crossing: $141,150 - $171,042
Princeton - NJ - US: $122,740 - $148,732
San Diego - CA - US: $135,010 - $163,605
Seattle - WA: $135,010 - $163,605
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.
R1596767 : Scientist, Predictive Biology and AI
$141.2k-171k yearly Auto-Apply 4d ago
Associate - Quality Assurance - Deviation Mentor
Eli Lilly and Company 4.6
Concord, CA 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.
The Deviation Mentor plays a critical role within the Quality Assurance (QA) organization, providing expertise, guidance, and training for deviation and laboratory investigations. This position is responsible for strengthening investigation quality, supporting inspection readiness, and leading select complex investigations.
Key Responsibilities
Deviation Investigation Leadership
* Guide and coach investigators in conducting high-quality deviation investigations, including root cause analysis, impact assessment, and technical documentation.
* Support reviewers and approvers by providing subject matter expertise in investigation practices.
* Lead complex or high‑risk investigations as needed.
* Participate in or facilitate deviation review boards, ensuring thorough evaluations for both pre‑approval and post‑approval stages.
* Contribute to deviation trending, monitoring, and reporting activities.
* Design and deliver training programs focused on investigation skills and deviation management.
* Develop and maintain site‑specific metrics related to deviations and investigations.
Qualifications
* Bachelor's or Master's degree in a scientific or technical discipline (e.g., Chemistry, Biology, Microbiology, Engineering).
* 5+ years of experience in pharmaceutical manufacturing operations; parenteral experience preferred.
* Strong technical writing and analytical problem‑solving capabilities.
* Excellent communication skills with the ability to provide clear, constructive feedback.
* Demonstrated ability to support collaboration, continuous improvement, and high‑quality documentation practices.
* Solid understanding of cGMPs, quality systems, and regulatory expectations.
Preferred Attributes
* 7+ years of QA experience in pharmaceutical or medical device industries.
* Experience with deviation management systems such as Veeva or TrackWise.
* Proficiency in CAPA, change control, and product complaint processes.
* Hands‑on experience supporting or preparing for regulatory inspections.
* Exposure to parenteral product materials and processes.
* Proven ability to influence and lead cross‑functional teams or project implementations.
Additional Information
* Some off‑hours or weekend coverage may be required to support 24/7 operations.
* Travel up to 10%, primarily domestic.
* Primary work location: Concord site (on‑site presence expected).
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
$63,000 - $162,800
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
$63k-162.8k yearly Auto-Apply 3d ago
Engineer - HVAC
Eli Lilly and Company 4.6
Concord, CA 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
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up.
The HVAC Engineer is the site Subject Matter Expert (SME) for site HVAC (GMP and non GMP) and the ancillary systems associated within the facilities. During the project phase, the HVAC Engineer will be a key player in the cross functional project team in charge of the construction, commissioning, qualification, start-up and operational readiness of all HVAC systems. During the day-to-day operation, the HVAC Engineer will be responsible for effectively, reliably, and cost effectively operating the site's HVAC (GMP and non-GMP) and ancillary systems associated within the facilities, maintaining all these systems in a state of compliance, in-control, and fit for use, capable of meeting all site needs. The HVAC Engineer will also be responsible for driving continuous improvement initiatives and local capital investment.
Responsibilities
* Be the SME with a deep technical expertise in all systems under his/her responsibility (GMP and non-GMP HVAC and ancillary systems associated within their facilities), understanding their applications in pharmaceutical manufacturing, understanding flow charts and process parameters, and awareness of industry trends.
* Ensure the assigned processes are in alignment with the Industry and Lilly Standards
* Support risk assessment exercises using the different tools available (e.g. FMEA)
* Participate as required in teams, committees, or other groups and/or individually to achieve the departmental, site and/or company goals
Initial project asset delivery phase and future local capital investment:
* Lead or participate in projects/changes for all the systems under his/her responsibility including Design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects.
* Develop the proper documentation (URs, Specification, test cases, etc..) to demonstrate that systems are properly installed, qualified and started up and that remains in a controlled state
* Contribute to the process resource assessment, capital plans, expense budgets, and prioritize appropriate
Daily Support to operations:
* Monitor utility systems and maintain KPI's to assure that they are operating properly, in compliance with requirements.
* Provide written instructions for the proper way to operate and maintain the equipment and process to assure that the system operates within the controlled parameters
* Implement efficient and effective maintenance and reliability techniques,
* Apply problem solving skills by leading equipment failures troubleshooting, demonstrating RCA lead investigator proficiency and guide operations personnel in the resolution of process issues.
* Provide customer consultation and notifications on issues that involve utilities areas assigned
* Assure that all necessary items are identified on the proper tracking systems, and make sure that items are completed by the required date
* Provide technical assistance as necessary to maintenance, and operations personnel
* Support internal and external inspections and investigations (including Quality and HSE)
* Maintain efficient communications with appropriate site customer groups
* Proficiency with the Trackwise and CAPA systems
Basic Requirements:
* Education Requirements: Bachelor's degree in Engineering (prefer ME, EE, Chem E).
* Technical experience of HVAC and Utilities
Additional Preferences:
* Demonstrated office software skills (Word, Excel, PowerPoint, Outlook, UMS, data historian) and collaboration sites
* Excellent interpersonal, written and verbal communication skills
* Knowledge of cGMP
* Demonstrated high level of understanding of engineering concepts, 1st principles, and engineering functional standards
* Strong technical aptitude and ability to train and mentor others
* Previous start up experience
* Engineering experience in the pharmaceutical industry
* Previous equipment commissioning experience
* Engineering experience with manufacturing plant utilities
* Project management experience
* Experience with maintenance and computerized maintenance management systems (CMMS)
* Previous experience with deviation and change management systems including Trackwise
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
$66,000 - $171,600
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
$66k-171.6k yearly Auto-Apply 16d ago
AD, Financial Controlling - Projects
Boehringer Ingelheim 4.6
Boehringer Ingelheim job in Fremont, CA
Lead and direct the Financial Controlling function responsible for supporting the US portion of BI's Global Functions Controlling and Allocations process. In addition to the leadership responsibilities with respective functional business partners the position may include strategic and operational tasks as follows:
Act as key Finance Business Partner to local and global management of respective US elements of BI Global Functions.
Ensure effective local and global partnership model by providing management with decision relevant financial and strategic guidance and financial transparency; challenging business partners/functional units appropriately in a market focused, solution oriented, and communicative approach.
Partner with functional leadership and Finance/Controlling leadership in development and implementation of local/global functional strategies.
Responsible for the accurate and timely development of functional project plans, budgets and forecasts consistent with global/local strategies.
Manage preparation of timely and accurate controlling reports.
Ensures compliance with BI and external standards and supports audit activities
Oversee coordination of EF allocations and consolidated reporting for all US entities.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
This position offers a base salary typically between $140,000 and $222,000. The position may be eligible for a role specific variable or performance based bonus, relocation and or other compensation elements.
Duties & Responsibilities
Planning/Budgeting, Reporting and Forecasting
Provide strategic direction for US portion of BI Global Functions financial reporting matters, in close collaboration with overall Finance & Controlling Team.
Support scenario simulations and development of alternatives including risk identification and related mitigation proposals
Lead, direct, coordinate and enhance all financial reporting matters for responsible areas. Drive process improvements and spirit of continuous innovation by challenging status quo
Management Accounting (incl. Closing), Cost Analysis and Product Costing
Provide comprehensive, timely analysis, with business specific interpretation (written commentary) to assist in smart business decision process.
Complete P&L and Balance Sheet responsibility for the area of responsibility.
Responsible for all intercompany accounting and transaction management related to business units.
Constructively challenge Business Partners, relative to market place, production volume & capacity assumptions and business trends, for optimum decision making to achieve financial objectives/targets.
Provide, timely, transparent, right-first-time, management reporting and analysis related to financial performance, headcount, CAPEX, etc.
Ensure verification & approval of (standard price) calculations results (also with governmental bodies where applicable).
Ensure alignment and coordination with GBS where applicable
Partnership, Alliance & Affiliates Controlling, International Projects
Lead/participate in (international) projects as needed and ensure local implementation and integration.
Key Finance stakeholder for US piece of BI Global Functions projects; establishing/measuring KPIs, leading/managing planning processes, and supporting global agreements.
Ensure cross-functional and global alignment and adherence to goals.
Operations / Manufacturing
Lead financial oversight and support development of contract manufacturing agreements
Support local negotiations with purchasing & local vendors
Ensure alignment of manufacturing schedule with forecast (optimize utilization)
Ensure support and execution of key operations processes like inventory count / cycle counts, contract manufacturing agreements
Audit / Compliance
Support BU Business Partner / OPU Central Controlling in Internal & External audits
Ensure and support of execution of CoSeA
Lead and support periodic compliance reviews (ensure quality & risk management compliance for commercial/operations processes)
Requirements
Bachelors, MBA or CPA from an accredited institution in Finance, Accounting or Engineering.
Six-plus (6+) years of work experience with increasing responsibility in Finance, Accounting and Operations.
Experience in Pharmaceutical or Scientific Financial area with responsibilities in Pharma.
Knowledge of BI processes a plus.
Good organizational, communication and planning skills with effective time management.
Ability to work under pressure, make good decisions and to multi-task and meet deadlines.
Strong attention to detail.
Ability to exercise critical thinking skills, proactively identify issues and address with solutions-oriented approach.
Ability to manage business partner relations and expectations.
Ability to focus on key issues and provide strategic alternatives/options.
Good interpersonal skills.
Ability to handle conflict resolution and negotiate difficult issues.
Professional Skills.
Ability to understand business risk and translate those risks to financial data and suggest mitigation strategies.
Ability to understand the value chain quickly and incorporate that acumen into value-added recommendations.
Ability to traverse the intersection of business, medicine, science and technology.
Position will balance multiple (often competing) priorities which will require the ability to demonstrate planning and organizational skills as well as sound business and technical knowledge to manage the workload effectively.
Requires strong cross functional collaboration skills and understanding of business strategies by interacting with the Business Partners so that financial/business advice, counsel and recommendations can be made to meet financial/business objectives.
Solid knowledge of, and collaboration with, functional management teams at the local and global organization level required.
Strong project management skills required to lead or participate in special projects/assignments as requested by Finance and business/operations leadership.
Desired Skills, Experience and Abilities
Eligibility Requirements
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.