Quality Control Scientist

Technical Operations San Francisco, California


Description

Position Summary:

The Quality Control Scientist will provide oversight of contract analytical labs and manufacturers. This includes, review of analytical data from release and stability studies and review of method validation protocols and reports. The candidate should have a strong understanding of cGMPs and relevant ICH and FDA regulatory guidelines. Prior hand-on experience working in a QC lab and thorough understanding of root cause analysis for investigations is required. This position will interact and work closely with cross-functional teams, including, manufacturing, quality assurance and regulatory.

Responsibilities:

  • Review analytical data packages generated during GMP release/stability testing of drug substance and drug product at the contract manufacturing sites
  • Assist in investigations and formulate a plan to identify/confirm root cause for anomalous results
  • Write and/or review method validation and transfer protocols and reports
  • Write and/or review protocols and reports related to stability studies as well as prepare tables summarizing results from stability studies
  • Track and trend release and stability data for batch analysis and shelf life establishment
  • Initiate change control for internal specifications and regulatory documents
  • Evaluate and perform risk assessment for change control documents provided by the contract manufacturing sites
  • Manage reference standard program for drug substance, impurities and degradants

Qualifications:

  • B.S. or M.S in analytical chemistry or related scientific disciplines with 5+ years of experience in analytical development with minimum of 3+ years of experience in quality control

Skills, Knowledge & Abilities:

  • Hands-on proficiency and problem-solving skills with chromatographic techniques e.g. HPLC, UPLC and GC. Familiarity with mass and UV/VIS spectroscopic techniques is an advantage
  • Prior experience in interacting with contract labs and manufacturing sites is a plus
  • Hands-on experience with method validations and transfers in support of pharmaceutical manufacturing
  • Proficiency in performing root cause analysis for investigation
  • Experience with iStability software is a plus
  • Passion for learning, creating, relating, communicating, and leading cross functional teams
  • Excellent verbal and written communication skills
  • Experience in a start-up environment preferred
  • Must be pro-active team player, flexible, and open to change

Working Conditions: Will work from the Company’s San Francisco Bay Area office, with additional travel as required to oversee the virtual development and manufacturing network (estimated at 25%).

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.

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 http://apellis.com/careerbenefits.html to learn more. 

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

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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 pneumocononiosis or any other characteristic protected under applicable federal, state or local law.