Job Title: Scientist 1 MSAT
About the JobThe Scientist I will develop and execute bioassays across various biologic modalities in support of commercial manufacturing and continuous improvement initiatives. In addition, this role will support Stability study management and the execution of biochemical and biophysical assays, as needed.
Main Responsibilities - Execute cell-based assays and immunoassays to assess product potency, biological activity, and impurities (e.g., residual DNA, HCPs) in support of late-stage programs, commercial biologics, and life cycle management programs
- Develop and optimize analytical methods including cell-based assays, ELISA, and flow cytometry for MSAT projects and technology transfer activities; perform general biochemical and biophysical assays under SME supervision, as needed
- Perform method qualification and transfer in and out of the department
- Work with analytical leads and relevant stakeholders to support sample stability studies
- Ensure timely completion of assignments and deliverables; independently design and execute complex experiments under general supervision
- Participate in characterization and comparability studies
- Author protocols, method development/technical reports, data analysis summaries, and investigation reports
- Write and review method documentation and characterization reports in support of regulatory filings
- Collaborate with other scientists in the team, as well as interact cross-functionally in the Global MSAT organization and interface functions and organizations, such as CMC, Quality, Manufacturing, CMO/CROs as appropriate
About You Basic qualifications: - PhD with 0-1+ years' experience in the biopharmaceutical industry, OR Master's degree with 3+ years' experience, OR Bachelor's degree with 6+ years' experience in the pharma/biotech industry within analytical development
- Scientific background in cell biology, biochemistry, molecular biology, immunology, or a related field
- 3+ years hands-on experience with cell-based assays, immunoassays (e.g., ELISA), and/or flow cytometry in a laboratory setting
- Experience in experimental design, method development, and qualification
- Strong analytical and problem-solving skills with the ability to troubleshoot complex assay issues and interpret scientific data
- Knowledge of mammalian cell culture and commercial protein purification processes
- Experience with bioanalytical equipment, software, and statistical tools for high-level data analysis
- Proficiency in data analysis tools and laboratory information management systems.
Skills and Competencies: - Highly organized and detail-oriented with a demonstrated commitment to quality and accuracy
- Able to work independently and collaboratively within cross-functional teams and with external partners; enthusiastic, self-motivated, and agile in responding to urgent requests, with the initiative to lead new tasks
- Excellent written and oral communication skills with the ability to present complex technical information clearly
- Strong time management and ability to prioritize multiple projects
- Ability to work full-time onsite in an analytical lab environment
Preferred qualifications: - Experience with method development, method qualification, and/or validation
- Knowledge and hands-on experience with sample stability testing and management
- Hands-on experience and comprehensive knowledge of other biochemical and biophysical techniques, including but not limited to U/HPLC, CGE, cIEF, spectroscopy, and particle analysis
- Familiarity with biologics manufacturing (monoclonal antibodies, vaccines, or other biotherapeutics)
- Experience working on highly technical projects requiring adaptability and responsiveness.
Why choose us? - Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation - at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
The salary range for this position is:
$85,500.00 - $123,500.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
