Scientist I OR Scientist II, DevOps Drug Substance, ONSITE, Fremont CA

Summary

Boehringer Ingelheim is a global leader in the pharmaceutical industry, dedicated to the discovery, development, and delivery of innovative products. The Scientist I/II, DevOps Drug Substance role focuses on the development and ownership of the drug substance process, applying scientific principles in a collaborative environment to execute and document experiments effectively.

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
• Maintains proper and timely data documentation
• Performs comprehensive data analysis of process statistics, identifies process deviations, and prepares and reviews protocols and technical reports
• 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
• Proposes 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 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

Skills

• 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
• Strong verbal and written communication and organization skills
• Able to perform in a team setting
• Highly self-motivated and detail-oriented
• Statistical analysis skills, including use of statistical software such as JMP and/or Minitab
• Able to lift up to 25 lbs
• The position requires some off hours, weekend, and holiday work
• 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

Qualifications

Must Haves

• 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
• Strong verbal and written communication and organization skills
• Able to perform in a team setting
• Highly self-motivated and detail-oriented
• Statistical analysis skills, including use of statistical software such as JMP and/or Minitab
• Able to lift up to 25 lbs
• The position requires some off hours, weekend, and holiday work
• 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

Benefits

• Role specific discretionary bonus
• Relocation
• Other compensation elements (not further specified)