Manager, External Manufacturing (Pharma)

TL;DR

Manager, External Manufacturing (Pharma): Development, optimization, scale-up, and routine execution of manufacturing operations for pharmaceutical products with an accent on oral solid tableting and CMO oversight. Focus on designing processes, troubleshooting equipment, executing validation protocols, and ensuring regulatory compliance.

Fully remote role requiring ability to be onsite at CMO in Greenville, NC (at least 25%) and frequent domestic & some international travel up to 25%.

$124,000–$161,000 annual

Company

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

What you will do

• Provide real-time and on-site supervision of CMO execution for routine manufacturing, technology transfer, optimization, and validation.
• Design, develop, and optimize manufacturing processes for pharmaceutical APIs and formulations, emphasizing oral solid tableting.
• Contribute to scale-up and tech transfer of tablet manufacturing processes at primary and secondary CMOs.
• Troubleshoot drug product process equipment for efficiency and GMP compliance.
• Develop and execute validation protocols (IQ, OQ, PQ) and prepare processes for registration and commercial readiness.
• Collaborate with R&D, manufacturing, quality, regulatory, and CMOs; analyze data and prepare reports for submissions.

Requirements

• Bachelor’s degree in Chemical Engineering or equivalent
• 5+ years in pharmaceutical process engineering, leading teams in regulated manufacturing improvements
• Experience with late phase clinical and commercial CMO operations
• Working knowledge of quality systems, validation, engineering design, and statistical process control
• Proven problem-solving with root cause analysis; familiarity with DOE
• Experience with GMP manufacturing, tech transfer, scale-up, and validation
• Ability to work independently remote from central leadership

Nice to have

• Strong background in oral solid tablet manufacturing and primary packaging

Culture & Benefits

• Comprehensive medical, dental, vision, mental health support, wellbeing reimbursement, EAP
• Generous PTO, fertility/family benefits, caregiver support, flexible schedules
• 401(k) with 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