Manager, Quality Control (QC) (Biotech)

TL;DR

Manager, Quality Control (QC) (Biotech): Independently lead and oversee QC activities at external contract laboratories for inhalation and small molecule drug substances and products with an accent on raw materials, in-process, release, and stability testing. Focus on managing analytical projects, deviations, investigations, and ensuring cGMP compliance while supporting regulatory submissions.

Location: Bridgewater, NJ office (requires full-time, in-person presence for hands-on collaboration, access to specialized equipment, and operational needs)

Salary: $124,000–161,000 Annual

Company

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

What you will do

• Manage and provide technical oversight of QC testing at contract laboratories for drug substances and products, emphasizing inhalation dosage forms
• Lead analytical projects from initiation to completion, aligning with timelines, quality, and regulatory requirements
• Review data packages, protocols, test results, and reports for compliance
• Manage deviations, OOS/OOT investigations, change controls, root cause analysis, and CAPAs
• Support analytical method implementation and troubleshooting for APSD, MMAD, delivered dose, and particle size distribution testing
• Review and approve CoAs, method validation/transfer protocols, and specifications
• Author QC sections for regulatory submissions (INDs, NDAs) and respond to agency inquiries
• Monitor contract lab performance and drive continuous improvement

Requirements

• Bachelor's degree in Chemistry, Biochemistry, or related scientific field
• 4+ years of Quality Control experience in biotech/pharmaceutical industry
• Experience in analytical testing of inhalation and/or small molecule drug products
• Strong understanding of cGMP, ICH guidelines, and USP/EP/JP standards
• Experience overseeing contract testing labs and reviewing analytical data/technical documents
• Analytical and problem-solving skills for investigations and CAPA implementation
• Effective communication, collaboration, time management, and prioritization skills

Nice to have

• Advanced degree (MS)
• Familiarity with combination products

Culture & Benefits

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