Scientist I OR Scientist II, DevOps Drug Substance, ONSITE, Fremont CA
About The Position
This onsite position in Fremont, California, is part of Boehringer Ingelheim’s Development Operations Drug Substance (DevOps DS) organization. The role supports process development for the complete drug substance process, from vial thaw through formulated drug substance, and process ownership throughout the product life cycle. Depending on level, the incumbent contributes as a project team member and may also coordinate or lead team activities. The work applies scientific principles and expertise in cell culture and/or purification CMC development to execute, analyze, and document experiments. Scientist I performs routine experiments with minimal oversight and complex experiments with regular team interaction; Scientist II performs complex experiments with regular team interaction and develops solutions to frequently encountered problems. Scientist II may represent DevOps DS on cross-functional teams. Both levels may direct and mentor junior group members and summer interns. The position supports scalable mammalian cell culture, harvest, and purification process development for biologics; documentation and analysis; laboratory and equipment upkeep; process and procedural improvements; technology and process development; training and safety compliance; technology transfer and manufacturing support; and regulatory filing activities. The position is scheduled Monday through Friday, with occasional off-hours, weekend, and holiday work to meet business, project, or operational needs. The base salary range is $75,600 to $113,400. The position may also be eligible for a role-specific discretionary bonus, relocation, and/or other compensation elements.
Requirements
- Scientist I: Bachelor’s degree with 2 or more years of relevant experience, or a master’s degree, in Chemical or Biochemical Engineering, Bioengineering, Biochemistry, Biology, or a related scientific field.
- Scientist II: Bachelor’s degree with 5 or more years of relevant experience, or a master’s degree with 3 or more years of relevant experience, or a Ph.D., in Chemical or Biochemical Engineering, Bioengineering, Biochemistry, Biology, or a related scientific field.
- Basic understanding of cell biology, biochemistry, protein separation, and analytics.
- Strong verbal and written communication and organizational skills.
- Ability to work in a team setting.
- Scientist I: Highly self-motivated, flexible, and willing to learn.
- Scientist II: Highly self-motivated and detail-oriented; demonstrated capability to identify and solve scientific problems.
- Scientist II: Statistical analysis skills, including use of statistical software such as JMP and/or Minitab.
- Ability to lift up to 25 lbs.
- Willingness to work some off-hours, weekends, and holidays.
- 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
- Support development of scalable mammalian cell culture, harvest, and purification processes for biologics; Scientist II may lead a small team in this work.
- Maintain proper and timely data documentation.
- Prepare development protocols and reports as needed; at Scientist II level, perform comprehensive process-statistics analysis, identify process deviations, and prepare and review protocols and technical reports.
- Perform routine equipment and laboratory maintenance, including equipment setup and ordering and storing supplies and chemicals.
- Identify, propose, and execute process and procedural changes to improve laboratory activities and organization, process performance, robustness, productivity, and efficiency.
- Assist with new technology innovation projects, new process development, and development of project scope and deliverables; Scientist II may propose these projects and initiatives.
- Participate in training and development opportunities to learn standards of practice and departmental policies.
- Complete required training and comply with procedures and safety guidelines to ensure worker safety.
- Assist with technology transfer and manufacturing support, including experimental work for deviation troubleshooting or investigations and occasional person-in-plant support.
- Support regulatory filings through compliance checks and data verification at Scientist I level, and authorship and review of CMC sections at Scientist II level.
- Collaborate with internal and external partners as required at Scientist II level.
- Direct and mentor junior group members and summer interns as needed.
Benefits
- Competitive compensation and benefit programs.
- May be eligible for a role-specific discretionary bonus, relocation, and/or other compensation elements.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
