Sr. Scientist, Preclinical Development

Job Description

Senior Scientist, Process Cell Sciences (PCS) at Rahway, NJ

The Biologics Process Research & Development organization within our company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics, and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and development and implementation of new manufacturing technologies. We work with our partners in our company's Manufacturing Division to commercialize and launch new products.

We are seeking a highly motivated and energetic individual to join our Process Cell Sciences (PCS) group as Senior Scientist. In this role, the successful candidate will work closely with team members of PCS and help develop and characterize mammalian production cell lines to support innovative biologics pipeline. Candidate must have experience in executing complex study designs requiring highly organized data collection and management. The selected candidate will be expected to work independently, including proactive planning, trouble shooting and successful execution of complex experimental protocols for cell line development and technology assessment. The selected candidate will be developed to serve as a technical lead and functional area representative on project teams.

Position Qualifications:

Education Requirement:

• PhD in Molecular Biology, Genetics, Biochemistry, or related Biological Sciences with at least 2 years of cell line development experience in industry.

• MS in Molecular Biology, Biochemistry, or related Biological Sciences with at least 4 years of cell line development experience in industry.

• BS in Molecular Biology, Biochemistry, or related Biological Sciences with at least 7 years of cell line development experience in industry.

Required Experience and Skills

• In-depth understanding of cell biology/molecular biology and hands-on experience of molecular subcloning, vector design, and mammalian cell culture.

• Familiar with industrial cell line development workflow.

• Experienced in cell line genetic characterization techniques (e.g., Southern blotting, gene copy number analysis, etc.)

• Experienced in regulatory filings (IND/IMPD, BLA/MAA).

• Excellent communication and interpersonal skills to work effectively in a team environment.

• Demonstrated ability to communicate complex issues in a succinct and logical manner.

• Strong technical writing skills

• Excellent project management skills in driving results within tight timeline

Preferred Experience and Skills

• Familiar with regulatory guidelines related to biologics cell line development and cell bank characterization.

• Knowledge in genomics, transcriptomics, proteomics and genome editing technologies.

• Flow cytometry

• Expertise of database and statistical software (e.g., JMP, …