Senior Manager, Drug Substance MSAT

Position Summary:

As part of the MSAT team, the Senior Manager of Drug Substance (DS) Manufacturing Science and Technology (MSAT) will lead tech transfer, process qualification, and validation at contract drug substance manufacturing sites. Responsibilities include process scalability, PPQ, monitoring, optimization, and manufacturability of drug substance and key intermediates. The role requires broad expertise in manufacturing and late-stage/commercial operations, supporting cross-functional teams. Technical support will be provided for both late-stage lifecycle and early-stage pipeline projects.

Key Responsibilities Include:

• Serve as MSAT technical expert on internal/external projects (process implementation, validation, tech transfer).
• Oversee product launch, tech transfer, process characterization (e.g., DOE, fate/purge studies), validation, and change management.
• Support risk management and troubleshooting for major deviations/change controls in collaboration with the supplier relationship team (SRT).
• Manage development and manufacturing activities through transparent communication and strategic alignment.
• Lead technical transfer and lifecycle planning from a manufacturing/scientific perspective.
• Proactively resolve technical challenges, deviations, and issues within scope.
• Ensure qualification/validation of processes, facilities, equipment, raw materials, and cleaning methods per GMP and global health regulations.
• Collaborate with cross-functional teams (PM, QC, QA, Supply Chain, Regulatory) for tech transfer, scale-up, and PPQ.
• Build strong relationships with development and manufacturing partners; coordinate with internal teams.
• Confirm equipment qualification as part of process validation (installation, operation, performance).
• Identify opportunities for continuous process improvement via trend analysis, technology advances, and industry standards.
• Support evaluation of major deviations, root cause analysis, CAPA, and change control with focus on quality, risk mitigation, and compliance.
• Apply risk management tools (e.g., FMEA, gap analysis) throughout lifecycle management.
• Develop data management processes for operational analysis, including Annual Product Review (APR) and Continuous Process Verification (CPV).
• Contribute to writing and reviewing CTD Module 3 sections for regulatory submissions (NDA, PAS, etc.).

Required Qualifications:

• Bachelor’s degree in life sciences/engineering; advanced degree (MS/PhD) preferred.

Experience:

• Extensive experience in cGMP development and manufacturing with strong MSAT background.
• Deep knowledge of pharmaceutical processes, technologies, and systems; experience in process development, tech transfer, scale-up, validation, and manufacturing.
• Proven track record in MSAT or related fields.
• Experience in process validation and lifecycle management.
• Familiarity with CTD Module 3 authorship and regulatory standards (FDA, EMA, ICH).
• Expertise in at least two modalities (e.g., peptides, oligonucleotides, biologics, small molecules, gene therapy) is a plus.

Skills, Knowledge & Abilities:

• Strong attention to detail and hands-on approach to project management (data, reports, dashboards, budgets).
• Excellent technical, communication, problem-solving, and organizational skills.
• Effective team player with ability to build strong internal/external relationships.

Other Requirements:

• Valid passport and ability to travel.
• Position based in Zug, Switzerland and requires 2-3 days office presence per week.
• Eligibility to work in Switzerland. 

Benefits and Perks:

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

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion 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 approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, 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 Twitter and LinkedIn

EEO Statement:

Apellis is an equal opportunity employer. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability.

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. 

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