Senior Scientist, Analytical Development (Large Molecule) (Biotech)

TL;DR

Senior Scientist, Analytical Development (Large Molecule): Managing internal analytical laboratory and overseeing CRO/CDMO activities for large molecule therapeutics, including method development, qualification/validation, transfer, and characterization of drug substances/products. Focus on designing and executing experiments using advanced techniques like HPLC/UPLC/SEC-MALS, ELISA, SPR/BLI, and biophysical assays to assess stability, purity, impurities, and critical quality attributes.

Location: Bridgewater, NJ office with full-time, in-person presence required

Salary: $127,000–$165,500 Annual

Company

Global biopharmaceutical company transforming lives of patients with serious and rare diseases.

What you will do

• Lead method development, qualification, testing, and transfer for large molecule projects, including protocol preparation, SOP review, and technical reporting.
• Develop strategies for quantitation, characterization, stability, release testing of drug substances/products using chromatography, electrophoresis, ELISA, and biophysical methods.
• Design/execute experiments for biochemical/biophysical properties, impurity assays (HCP, Protein A, host cell DNA, bioburden, endotoxin), and bioanalytical methods (SPR, BLI, cell-based assays).
• Collaborate with internal teams, CROs/CDMOs on method transfer, stability testing, regulatory documents (INDs, CTAs, BLAs), and vendor evaluations.
• Present results to cross-functional teams and serve as SME for analytical development in preclinical projects.
• Maintain detailed records and optimize protein properties via engineering efforts.

Requirements

• BS in Chemistry/Biochemistry +8 years, MS +6 years, or PhD +3 years experience in biopharmaceutical industry
• Hands-on expertise in analytical techniques: chromatography (HPLC/UPLC/SEC/IEX/RP), mass spec (LC-MS), SEC-MALS, DLS, DSC, CD, CE-SDS, ELISA, SPR, BLI, cell assays.
• Proficiency with instruments: plate-readers, UV/Vis, RT-PCR, microscope; Waters/Empower preferred.
• Strong understanding of GxP, CMC, ICH, compendial standards; statistical skills.
• Excellent presentation/communication skills; highly organized with attention to detail.
• Demonstrate core values: Collaboration, Accountability, Passion, Respect, Integrity.

Culture & Benefits

• Comprehensive medical/dental/vision, mental health support, EAP, wellbeing reimbursement.
• Generous PTO, fertility/family benefits, caregiver support, flexible schedules.
• 401(k) with match, equity awards, ESPP, company-paid life/disability insurance.
• Learning Institute: LinkedIn Learning, workshops, leadership programs, mentorship.
• Employee resource groups, volunteering, recognition programs.
• Minimal travel expected.