Sr Associate Scientist, FPD
About The Position
We are seeking a highly motivated, attentive, and self-driven candidate to join our team, Biologics Pivotal & Commercial Formulation and Process Development, as an Sr. Associate Scientist. The successful candidate will contribute to the development of formulation and drug product processes for innovative molecules to support to advance medicines into the clinic. The candidate will have opportunities for career growth through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment. The ideal candidate is expected to be action oriented with high expectations of themselves and others and should possess good verbal and written communication and interpersonal skills.
Requirements
- MS/MA with 4+ years, or BS/BA with 6+ years of industrial experience in biologics CMC development.
- Hands-on laboratory experience required.
- Experience with formulation development, Drug Product process development, and clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats strongly desired.
Responsibilities
- Design and successfully execute experiments and activities to support formulation and drug process development, including formulation development, Drug Product manufacturing process development, and clinical in-use evaluations.
- Demonstrate understanding of analytical, biophysical characterization, and process development techniques; lead by example for lab executions.
- Clearly, timely, and accurately document data in appropriate repositories such as lab notebooks, reports, protocols, etc. following good documentation practices.
- Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and external audience.
- Effectively collaborate with both internal and external stakeholders in project meetings.
- Analyze data and draft conclusions before discussing with manager or supervisor.
- Support or represent function and work collaboratively on cross-functional teams to support project team strategy and regulatory filings.
- Fully embrace a lean-agile mindset, matrix working environment, and continuous improvement.
- Help support key project or department stakeholders as needed to ensure that company objects are met.
- Support team initiatives to drive business process excellence, scientific innovation, laboratory and work safety, etc.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
