Manager, Manufacturing Technical – Drug Product

Apellis Pharmaceuticals • Waltham, MA

17d • $114,000 - $171,000

About The Position

Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. Summary: As part of the Manufacturing Technical Team (within TO CM&S), the Manager, Manufacturing Technical – Drug Product is accountable for the development, implementation, and oversight of the supply at Apellis’ Contract Manufacturing Organizations. Will assume the responsibility for deviation handling as a part of the Supplier Relationship Team (SRT) for Drug Product (DP). The individual will be responsible for assuring Drug Product conforms to regulatory and company standards and satisfies GMP regulations. The Manager, Manufacturing Technical – Drug Product will bring advanced skills in late-stage development and commercial phase technical processes, also supporting other functional areas.

Requirements

• College degree in life science or engineering or in a related area.
• Work experience in pharmaceutical manufacturing with focus on technical and engineering topics or related areas.
• Experience in batch release, deviation handling and change controls.
• Proven track record of experience in late-stage clinical or commercial manufacturing.
• Demonstrated ability to work effectively in a team environment.
• 5+ years of progressive experience in pharmaceutical manufacturing with at least 2 years of experience in manufacturing technical related topics like major deviation handling, batch record review, change controls, regulatory, quality and others.
• Proficient technical computer skills, communication, comprehension, interpretation, problem-solving, team spirit, critical thinking and organization skills.

Responsibilities

• Handling of manufacturing topics in late stage and commercial phase, such as batch release, deviations (technical deviation management) and change controls as a part of the Supplier Relationship Team for drug products.
• Plan and organize manufacturing schedules with Contract Manufacturing Organizations (CMOs) ensuring consistent material availability for all manufacturing activities, including adequate planning for long lead time items.
• Review batch production records and written instructions to ensure cGMP compliance and maintain regulatory and quality compliance.
• Oversee production processes on-site with the CMOs and establish/review organized filing of CMO documentation.
• Monitor CMO performance and communicate findings, including risks and opportunities, to internal stakeholders and trigger corrective countermeasures.
• Assist in conducting CMO audits to assess and quantify their demonstrated manufacturing capabilities and capacities.
• Act as steward of processes and standards in the SRT (e.g. documentation of processes and capabilities, process enhancement) by proactively anticipating, evaluating, and resolving technical challenges within the area of expertise.
• Day-to-day manufacturing operations: batch record review, investigations, CAPAs.
• Make recommendations to QA by reviewing deviations, investigations, supplier risk assessments, mitigation plans and CAPAs.
• Use risk management, investigational techniques, root cause analysis and quality concepts in the identification and evaluation of compliance risks in concert with QA.
• Study and analyze process improvements to gain efficiency and increase productivity through ongoing routine process monitoring (e.g. CPP trending), and support continuous process verification.
• Review essential elements of scale-up and technology transfer leading to successful process validation and robust commercialization.
• Gather knowledge as the basis for the manufacturing control strategy, the approach for process qualification and continuous process improvements.
• Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal teams.
• Participate in the active writing and review of CMC modules for clinical and commercial regulatory submissions (NDA, IND, etc.).
• Participate in various cross-functional projects as needed and appropriate.

Benefits

• Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more!
• Visit https://apellis.com/careers/benefits/ to learn more.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager