Senior Scientist, Analytical Development

Technical Operations San Francisco, California


Description

Position Summary:

Apellis is developing peptides designed to broadly inhibit complement C3, a central element of the complement cascade. The Senior Scientist, Analytical Development will be responsible for developing analytical techniques to support drug substance and drug product formulation development activities. 

Responsibilities:

  • Develop analytical techniques to support drug substance process and drug product formulation development activities
  • Manage analytical method development to support characterization of drug substance and drug products
  • Apply scientific principles in selecting appropriate techniques for development of sensitive and robust methods
  • Troubleshoot analytical methods, hardware and software issues arising at CROs/CMOs
  • Research new techniques and recommend alternative approaches and potential solutions to analytical issues
  • Write analytical test methods, protocols and reports as part of analytical transfers to CROs/CMOs for GMP testing
  • Contribute to authoring of CMC sections to support regulatory filings
  • Serve as an analytical subject matter expert within department and cross-functional areas

Qualifications:

  • Ph.D in analytical chemistry or related disciplines, with at least 5 years relevant experience in pharmaceutical industry

Skills, Knowledge & Abilities:

  • Extensive knowledge and hands-on experience on chromatographic and spectroscopic techniques (e.g. GC, HPLC, MS, UV/Vis)
  • Knowledge of techniques required for physicochemical characterization of drug substance (e.g., particle size, TGA, DVS, DSC etc.)
  • Experience with analytical method validations and transfers in regulated environments is required
  • Experience with development and validation of methods for bioassay to determine potency is a plus
  • Attention to detail and excellent analytical skills as applied to data review and investigations
  • 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.

 

 

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.