Scientist I OR Scientist II, DevOps Drug Substance, ONSITE, Fremont CA
About The Position
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 Scientist I, DevOps Drug Substance is a member of Development Operations Drug Substance (DevOps DS), responsible for process development of the entire drug substance process (from vial thaw to formulated drug substance) and process ownership throughout the product life cycle. Operating as a DevOps DS project team member and occasionally as a coordinator, the incumbent applies scientific principles and process knowledge and expertise in cell culture and/or purification CMC development to execute, analyze, and document routine experiments with minimal oversight and complex experiments with regular team interaction. The Scientist I, DevOps Drug Substance also may direct and mentor junior group members and summer interns. The Scientist II, DevOps Drug Substance is a member of Development Operations Drug Substance (DevOps DS), responsible for process development of the entire drug substance process (from vial thaw to formulated drug substance) and process ownership throughout the product life cycle. Operating as a DevOps DS project team member and occasionally as a team leader/coordinator, the incumbent applies scientific principles and process knowledge and expertise in cell culture and/or purification CMC development to execute, analyze, and document complex experiments with regular team interaction, and develop solutions to address frequently encountered problems. The Scientist II, DevOps Drug Substance also occasionally serves as the DevOps DS representative on a cross-functional project team and directs and mentors junior group members and summer interns.
Requirements
- BS with two-plus (2+) years of relevant experience or MS in Chemical / Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field.
- Basic understanding of cell biology, biochemistry, protein separation, and analytics.
- Strong verbal and written communication and organization skills.
- Able to perform in a team setting.
- Highly self-motivated, flexible, and willing to learn.
- Able to lift up to 25 lbs.
- The position requires some off hours, weekend, and holiday work.
- BS with five-plus (5+) years of relevant experience or MS with three-plus (3+) years or PhD, in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field.
- Demonstrated capability to identify and solve scientific problems.
- Highly self-motivated and detail-oriented.
- Statistical analysis skills, including use of statistical software such as JMP and/or Minitab.
- 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.
Responsibilities
- Supports the development of scalable mammalian cell culture, harvest, and purification processes for biologics.
- Maintains proper and timely data documentation.
- Prepares development protocols and reports as needed.
- Performs routine equipment and lab maintenance activities, including equipment set up, supply and chemical ordering and storage.
- Identifies, proposes, and executes process and procedural changes to improve lab activities and organization, process performance, robustness, productivity, and efficiency.
- Assists in new technology innovation projects, development of new processes, and development of project scope and deliverables for execution and implementation.
- Participates in training and development opportunities to gain an understanding of standards of practice and departmental policies.
- Ensures worker safety by completing training and complying with procedures and safety guidelines.
- Assists in tech transfer and manufacturing support including experimental work for deviation troubleshooting and occasional person-in-plant as required.
- Supports regulatory filings by contributing to compliance check and data verification.
- Supports, and may lead a small team in pursuit of, the development of scalable mammalian cell culture, harvest, and purification processes for biologics.
- Performs comprehensive data analysis of process statistics, identifies process deviations, and prepares and reviews protocols and technical reports.
- Proposes new technology innovation projects, development of new processes, and development of project scope and deliverables for execution and implementation.
- Assists in tech transfer and manufacturing support including deviation investigations and occasional person-in-plant as required.
- Collaborates with internal and external partners as required.
- Supports regulatory filings by contributing to authorship and review of CMC sections.
Benefits
- competitive compensation and benefit programs
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
