Manufacturing Technical Manager

4 weeks ago

Waltham, Massachusetts, United States Apellis Full time
Job Overview

Apellis Pharmaceuticals is seeking a highly skilled Manufacturing Technical Manager to join our team. This role is accountable for the development, implementation, and oversight of the supply at Contract Manufacturing Organizations (CMOs). The successful candidate will assume responsibility for deviation handling as part of the Supplier Relationship Team (SRT) for Drug Product (DP).

Key Responsibilities:

  • Handling of manufacturing topics in late-stage and commercial phase, including batch release, deviations, and change controls.
  • Planning and organizing manufacturing schedules with CMOs to ensure consistent material availability.
  • Reviewing batch production records and written instructions to ensure cGMP compliance.
  • Overseeing production processes on-site with CMOs and establishing/reviewing organized filing of CMO documentation.
  • Monitoring CMO performance and communicating findings to internal stakeholders.
  • Assisting in conducting CMO audits to assess manufacturing capabilities and capacities.
  • Acting as a steward of processes and standards in the SRT, anticipating and resolving technical challenges.
  • Day-to-day manufacturing operations, including batch record review, investigations, and CAPAs.
  • Making recommendations to QA by reviewing deviations, investigations, and supplier risk assessments.
  • Using risk management, investigational techniques, and quality concepts to identify and evaluate compliance risks.
  • Studying and analyzing process improvements to gain efficiency and increase productivity.
  • Reviewing essential elements of scale-up and technology transfer for successful process validation and commercialization.
  • Gathering knowledge for the manufacturing control strategy and process qualification.
  • Establishing effective relationships with development and manufacturing partners.
  • Participating in the writing and review of CMC modules for clinical and commercial regulatory submissions.

Requirements:

  • College degree in life science or engineering or a related area.
  • Work experience in pharmaceutical manufacturing with a focus on technical and engineering topics.
  • Knowledge of pharmaceutical, technical, manufacturing, and engineering processes.
  • 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.

Physical Demands and Work Environment:

  • This is a largely sedentary role with some filing required.

Travel Requirements:

  • Up to 20% travel expected.

Benefits and Perks:

Apellis offers a great benefit package, including health insurance, 401K, paid time off, long-term disability insurance, and life insurance.

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