Senior Manager, Analytical Development

Position Summary:

The Senior Manager, Analytical Development will support the analytical development and quality control of small molecules, peptides, oligos, and/or biological products. The successful candidate will support CMC teams and oversee CROs/CMOs performing analytical method development and validation, in-process, release, and stability testing, characterization, forced degradation studies, etc. The incumbent should have experience with phase-appropriate development strategies and familiarity with regulatory guidance's and cGMP. This role will have close technical collaboration with internal stakeholders, including but not limited to, members from Pharmaceutical Development, Process Development, Quality Assurance, and Regulatory functions

Key Responsibilities Include:

• Review and/or approve test methods, validation protocols and reports, stability reports, specifications, and comparability protocols to support the control of drug substances, drug products, and intermediates.
• Author and review CMC sections of regulatory filings (including INDs, IMPDs, NDAs/MAAs, briefing packages and other regulatory dossiers).
• Supports the team in the management of the reference standard and stability programs.
• Author quality records (change controls, deviations, investigations) to implement method changes and/or to investigate non-conformances, OOS/OOT, and CAPA.
• Review analytical data packages generated during GMP testing of in-process, intermediates, drug substance and drug product samples.

Education, Registration & Certification:

• Ph.D., M.S., or Bachelors in analytical chemistry or related scientific disciplines.

Experience:

• 7 years of industry experience.

Skills, Knowledge & Abilities:

• Hands-on experience in common pharmaceutical analytical techniques and instrumentation (i.e. HPLC/UPLC, bioassay, MS, etc.)
• Extensive experience with analytical method development, validation, and transfer, stability management, reference standard management, cGMP
• Experience working with contract testing laboratories.
• Knowledgeable in FDA/EU/ICH regulations and guidance related to small molecule and biologics drug substance and drug product development.
• Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities ensuring effective time management.
• Ability to work independently as well as collaboratively in a team environment.
• Demonstrate flexibility and ability to work in a fast-paced environment.

Physical Demands and Work Environment:

• This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• 15% travel.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more! Visit to learn 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 or follow us on and

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.