Manager, Quality Control – Technical Services

Position Summary:

The QC Technical Services Manager will primarily be responsible for leading technical and scientific aspects of Quality Control. The successful candidate should have significant hands-on experience in QC operations (focus on microbiological methods preferred), leading OOS/OOT investigations, leading method validation and transfer, overseeing stability and reference standard programs, etc. The manager should be well versed with regulatory guidelines and expectations related to cGMP, compliance, and data integrity. The incumbent will have close technical collaboration with internal stakeholders, including but not limited to, members from Quality Assurance, Manufacturing, CMC, Regulatory and Analytical Development 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:

• Review and/or approve analytical test methods to ensure methods are robust and suitable to support release/stability testing of raw material, intermediates, drug substance and/or drug product samples,
• Support the team in the management all aspects of the reference standard and stability programs.
• Participate in regulatory inspection as a SME. Ensure all appropriate documents are generated and retrievable per GMP standards in support of regulatory submissions and inspections.
• Author quality records (change controls, deviations, investigations, etc.) to implement method changes and/or to investigate non-conformances, OOS/OOT, and CAPA.
• Establish an effective working relationship with internal cross functional teams to provide QC related scientific and technical support.
• Review analytical data packages generated during GMP (release, stability, validation, etc.) testing of in-process samples, key intermediates, drug substance and drug product samples.
• Prepare and deliver inter-departmental presentations with effective expression of ideas, complex quality concepts, and solid rationale.
• Perform gap assessment and support optimization efforts to increase method robustness as part of the life cycle management project.
• Author, review and/or approve QC related SOPs, test methods, validation protocols and reports, stability report, regulatory filings and responses, specification documents, APQR, etc.
• Communicate and /or escalate any quality related issue to the management in a timely manner.

Education, Registration & Certification:

• B.S. or M.S in analytical chemistry or related scientific disciplines.

Experience:

• 5+ years of industry experience in a GMP QC environment.

Skills, Knowledge & Abilities:

• Deep understanding in the areas of analytical and microbiological method lifecycle, method validation, method transfer, stability management, reference standard management, establishing and trending QC metrics, etc.
• Knowledgeable in FDA/EU/ICH regulations and guidance related to critical quality attributes, release testing, analytical validation and transfer, and stability testing.
• Ability to work independently as well as collaboratively in a team environment.
• In depth knowledge of stability program with the ability to identify product degradation, and out of trend (OOT) or atypical results.
• Demonstrate flexibility and ability to work in a fast-paced environment.
• Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities ensuring effective time management.
• Expert level knowledge with hands-on experience in common pharmaceutical analytical techniques and instrumentation (i.e. HPLC/UPLC, GC, dissolution, water content, particle size, bioassay, container closure integrity, etc.)
• Well-versed with hands on experience (preferred) in microbiological tests (sterility, endotoxin, bioburden, microbial enumeration test, identification, and isolation), environmental monitoring and control, as per regulatory guidance.

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:

• Travel estimated at 15%

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.

The salary range for this position is $118,000 USD to $145,000 USD annually. Actual pay will be determined based on various factors including education, experience, qualifications, and other job-related factors permitted by law. This position is also eligible for bonus, benefits, and participation in Company’s equity plan.
Company Background:

At Apellis, we are committed to developing transformative therapies for people living with a broad range of debilitating diseases by controlling complement, part of the body’s immune system. Our work is rooted centrally at C3, which is the only target in the complement cascade that addresses all three pathways that can drive disease. Targeting C3 has broad platform potential to treat many diseases where patients have few or no treatment options available. Our programs across ophthalmology, nephrology, hematology, and neurology are further exploring what is possible by targeting C3.

Visit https://apellis.com/about-us/ut.html to learn more.

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.