Manager, Manufacturing Technical – Drug Product

Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. 

Summary:

At Apellis, we are driven by science and inspired by patients.
We are looking for a skilled and proactive Technical Manufacturing Manager – Drug Product to join our Technical Operations team. This role is critical in ensuring the reliable supply of high-quality drug products through strategic oversight of our Contract Manufacturing Organizations (CMOs). You will play a key role in managing technical aspects of late-stage development and commercial manufacturing, with a strong focus on combination products and sterile processes.

Roles and Responsibilities:

As a core member of the Supplier Relationship Team (SRT), you will:

  • Manage technical operations for drug product manufacturing, including batch release, deviation handling, and change control processes.
  • Coordinate manufacturing schedules with CMOs to ensure timely availability of materials, especially for long lead-time items.
  • Review batch production records and manufacturing instructions to ensure compliance with cGMP and regulatory standards.
  • Collaborate with QA to assess deviations, investigations, CAPAs, and supplier risk mitigation strategies.
  • Monitor and evaluate CMO performance, identifying risks and opportunities, and initiating corrective actions when needed.
  • Apply risk management and root cause analysis to identify and address compliance risks.
  • Drive process optimization, using data-driven insights (e.g., CPP trending) to enhance efficiency and support continuous process verification.
  • Champion process stewardship, proactively resolving technical challenges and driving continuous improvement across manufacturing operations.
  • Support audits and inspections, assessing manufacturing capabilities and ensuring documentation is organized and accessible.
  • Contribute to regulatory submissions, including CMC modules for INDs and NDAs.
  • Engage in cross-functional projects, bringing technical expertise to broader organizational initiatives.

Education & Experience:

  • A degree in life sciences, engineering, or a related field.
  • 5+ years of experience in pharmaceutical manufacturing, with a strong background in technical operations and engineering.
  • Proven expertise in combination products, including device assembly, labeling, packaging, and serialization.
  • Hands-on experience with sterilization processes, including cycle report reviews and critical parameter analysis.
  • Deep understanding of GMP, regulatory compliance, and quality systems.
  • Strong skills in batch record review, deviation management, and change control.
  • Excellent problem-solving, communication, and organizational abilities.
  • Ability to work effectively in cross-functional teams and manage external partners.
  • Must be authorized to work in Switzerland and hold a valid passport.

Work Arrangement:

Travel Requirements:

None.
‎

Education:

Bachelor's Degree 

Benefits and Perks:

Apellis offers a comprehensive benefits package, inclusive flexible time off, summer and winter shutdowns, paid family leave and more!


Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

 

For more information, please visit http://apellis.com or follow us on LinkedIn and X.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.