United States onlyPosition Summary:
The Manager, Quality Control supports Tech Ops objective on GMP compliance and is a key member of the QC team.
Key Responsibilities Include:
- Work closely with contract partners to ensure timely release testing and stability programs of Apellis drug substance and commercial drug product.
- Author well written quality records (change controls, deviations, investigations, etc.) to implement method changes and/or to investigate non-conformances, OOS/OOT, and CAPA primarily for commercial stage drug product/drug substance.
- Critically review commercial stage/late-stage analytical data packages (release, stability, validation, etc.) generated for GMP manufacturing and testing of in-process samples, starting materials and key intermediates, drug substance and drug products, with a GMP perspective.
- Conduct data verification for analytical data in regulatory submissions
- Author and/or review QC related SOPs
- May author and review test methods, validation protocols and reports, stability reports, regulatory filings and responses, specification documents, APQR, etc.
- Support/manage reference standards, QC metrics and stability programs.
- Contribute to an effective working relationship with internal cross functional teams to provide QC related technical support.
- Support method validation and method transfer activities
- Communicate and /or escalate any quality related issues to the management in a timely manner.
Education, Registration & Certification:
- BS degree in analytical chemistry with a minimum of 6 years of method development or validation experience in GMP pharmaceutical industry is required. Advanced degree with few years of experience and in other relevant scientific disciplines may be considered.
Experience:
- Prior experience in interacting with contract manufacturing organizations and contract laboratories including data review and oversight of product release and stability testing.
- Detail oriented, excellent follow through, and persistent in ensuring investigations are resolved timely in a compliant manner.
- Effective communication (oral and written) and collaboration with internal team members.
- Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment.
- Prior experience using typical analytical testing equipment such as HPLC.
- Experience with drug substance QC is strongly preferred.
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 and bend or stand on a stool as necessary. 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:
- Up to 20% travel expected.
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/ 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.
