Senior Scientist, Analytical Development

Job Description

Job Description

Position Summary :

The Senior Scientist, Analytical Development will support the analytical development and GMP activities of small molecules, peptides, oligos, and / or biological products.

The successful candidate will support CMC teams and oversee CROs / CMOs / CTLs performing analytical method development and validation, in-process, release, and stability testing, characterization, forced degradation studies, etc.

The incumbent should possess essential skills in key analytical technologies, have experience with phase-appropriate development strategies and familiarity with regulatory guidelines and cGMP requirements.

This role will have close technical collaboration with internal stakeholders, including but not limited to, members from Pharmaceutical Development, Process Development, Quality Assurance, manufacturing and Regulatory functions.

The successful candidate will need to be flexible and agile with the ability to pivot quickly to changing circumstances and business needs.

Key Responsibilities Include :

• Work with internal teams and external sites to support the development of Apellis pipeline programs.
• May directly manage and oversee the analytical activities at CROs / CMOs / CTLs for relevant programs, ensuring the deliverables align with / meet program needs.
• Author and review analytical documents such as analytical development reports, test methods, validation protocols and reports, stability protocols and reports, specifications, etc.

to support the testing and control of drug substances and drug products.

• Review analytical data packages generated at external sites.
• Selection, characterization and maintenance of reference standards for each program.
• Define and oversee stability studies as required for individual programs to support retest period / shelf-life assignment and extension.
• Author quality records (change controls, deviations, investigations) to implement method changes and / or to investigate non-conformances, OOS / OOT, and CAPA.
• Author / contribute to other technical reports, including, but not limited to comparability protocols / reports, risk assessments, and justification of specifications, etc.
• Contribute to CMC sections of regulatory filings (including INDs, IMPDs, NDAs / MAAs, briefing packages and other regulatory dossiers) as needed.
• Participate actively in internal and external project meetings, representing AD functions as appropriate.

Education, Registration & Certification :

Minimum B. S. in analytical chemistry or related scientific disciplines, advanced degree (M.S. or Ph.D.) preferred.

Experience :

• 10+ years of relevant industry experience, preferably prior GMP roles for CMC
• Experience may be compensated by advanced degree(s)

Skills, Knowledge & Abilities :

Theoretical understanding and hands-on experience in common analytical techniques and instrumentation for pharmaceutical analysis (i.

e. HPLC / UPLC, bioassay, MS, microbiological tests, etc.).

• Extensive experience with analytical method development, validation, and transfer, stability requirements, reference standard characterization and management.
• Experience working with contract laboratories.
• Knowledgeable in FDA / EU / ICH regulations and guidance related to small molecule and biological drug substance and drug product development
• Proven ability of managing 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. This job operates in a professional office environment and routinely uses standard office equipment such as computers and phones, etc.

Travel Requirements :

Up to 15% travel expected.

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 https : / / apellis.

com / careers / 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 http : / / apellis.com or follow us on Twitter and LinkedIn

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.