Sr Mgr, Drug Substance Process Development

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

Summary:

Roles and Responsibilities:

Key Responsibilities Include:

• Serve as 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 Continous Process Verification (CPV).
• Contribute to writing and reviewing CTD Module 3 sections for regulatory submissions (IND, NDA, PAS, etc.).

Required Experience & Qualifications:

• Bachelor's degree in life sciences/engineering; advanced degree (MS/PhD) preferred.
• Extensive experience in cGMP development and manufacturing APIs.
• Deep knowledge of pharmaceutical processes, technologies, and systems; experience in process development, tech transfer, scale-up, validation, and manufacturing.
• Proven track record in process development or related fields.
• Experience in process validation and lifecycle management.
• Familiarity with CTD Module 3 authorship and regulatory standards (FDA, EMA, ICH).
• Strong attention to details 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.
• Expertise in at least two modalities (e.g., peptides, oligonucleotides, biologics, small molecules, gene therapy) is a plus.

Travel Requirements:

Education:

Pay Information:

Work Arrangement:

Benefits and Perks:

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.

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.comor follow us on LinkedIn andX.

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. 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, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.
For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

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.