Apellis Pharmaceuticals · 5 hours ago
Sr Mgr, Drug Substance Process Development
Waltham, MA
Full-time
Onsite
Senior Level
$159K/yr - $239K/yrApellis Pharmaceuticals 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. The Sr. Manager of Drug Substance Process Development will lead tech transfer, process qualification, and validation at contract drug substance manufacturing sites, requiring expertise in manufacturing and late-stage operations.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
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.)
Qualification
Required
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
Preferred
Expertise in at least two modalities (e.g., peptides, oligonucleotides, biologics, small molecules, gene therapy) is a plus
Benefits
401(k) plan with company match
Inclusive family building benefits
Flexible time off
Summer and winter shutdowns
Paid family leave
Disability and life insurance
Company
Apellis Pharmaceuticals
Apellis Pharmaceuticals focuses on developing novel therapeutics and drug delivery technologies to address chronic inflammatory diseases.
Founded in 2008
501-1000 employees
H1B Sponsorship
Apellis Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (6)
2023 (6)
2022 (8)
2021 (7)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$919.6MKey Investors
Swedish Orphan BiovitrumSixth StreetNorthern Star Partners
2025-06-01Post Ipo Debt· $275M
2024-05-14Post Ipo Debt· $475M
2022-04-14Post Ipo Equity· $1.07M
Leadership Team
Cedric Francois
Co-Founder and CEO
Caroline Baumal
Chief Medical Officer
Recent News
2026-01-18
Investor's Business Daily
2026-01-13
Company data provided by crunchbase