Sr Scientist - Biologics Drug Product Development
About The Position
Regeneron is seeking a Sr. Scientist to join its Drug Product Development and Technology (DPDT) Department. The role supports drug product development from candidate selection and pre-clinical development through clinical development and commercialization. The work may involve modalities such as monoclonal antibodies, engineered proteins, siRNA, and antibody-oligonucleotide conjugates, as well as liquid and lyophilized drug products and novel drug delivery technologies. The scientist will work independently and may lead a project or program, applying biochemical, biophysical, and/or microbiology principles to execute experiments and processes ranging from simple to complex. Areas of focus may include formulation development and stability, compatibility and in-use stability, analytical and process development, microbial analysis, and new technology development. The position is full-time and on-site in Tarrytown, New York.
Requirements
- Ph.D. in Pharmaceutical Science, Biochemistry, Chemistry, Microbiology, Biophysics, Engineering, or a related field, or a bachelor's or master's degree with equivalent experience.
- Bachelor's or master's degree with 8–10 years of experience, or Ph.D. with 0–3 years of experience.
Responsibilities
- Independently design and conduct rigorous experiments, potentially involving formulation development, new technology, microbial challenge testing, process development, and technology transfer.
- Research and implement new approaches to problem-solving and process optimization for product development and technology evaluations.
- Collaborate with DPDT and cross-functional teams to support timely completion of deliverables.
- Prepare and deliver oral and written presentations and contribute to publications, SOPs, and patents.
- Ensure data quality and interpretation, and maintain accurate records consistent with company policy and legal requirements.
- Use scientific and statistical knowledge and software such as JMP or equivalent to support study design and data analysis.
- Make timely decisions of moderate complexity, including decisions based on limited information with guidance.
- Participate in DPDT meetings, prepare data presentations, and communicate results in subgroup or department meetings.
- Train less experienced scientists and potentially mentor junior colleagues by reviewing their work and providing constructive feedback.
- Participate in laboratory and instrument maintenance and potentially serve as an instrument team lead or subject matter expert.
- Potentially introduce and lead development efforts for new instrumentation and analytical techniques.
- Lead and plan projects to meet program deliverables and timelines.
- Generate internal reports and contribute to protocols, analytical procedures, technical reports, process transmittals, developability risk assessments, and regulatory documents.
- Maintain complete and accurate laboratory records and comply with data integrity procedures and systems, including ELN, SDMS, LIMS, and EDMS.
- Comply with EHS and DPDT safety requirements, governance documents, and required compliance training.
Benefits
- Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
