Associate Director, Pharmaceutical 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 Associate Director, Pharmaceutical Development is responsible for designing and developing sterile products for peptide and other platform drugs for injectable and ophthalmic routes of administration. Support for both early and late stage development candidates will include ensuring screening and development of robust drug product composition, scalable process, primary packaging, and compatibility characterization for processing and administration.  The position will collaborate with internal teams, consultants, development organizations, CMOs, and suppliers to lead this key function for the organization.

Responsibilities:

  • Responsible for day-to-day internal and external pre-formulation, and formulation development activities
  • Utilization of a variety of physical and chemical characterization techniques to develop an understanding of the physicochemical characteristics of drugs and associated formulations
  • Collaborate with CMC and development teams to deliver on project milestones
  • Maintains efficient, innovative and CMC processes which provide fast path to decision points without compromising on quality and regulatory requirements
  • Active contribution to CMC activities in preclinical and clinical development and candidate characterization reports
  • Will be responsible for identifying and selection of third party vendors that would perform the required formulation development work
  • Will be the scientific lead responsible for successful formulation development at third party vendors

Qualifications:

  • Degree in life sciences / engineering
  • Approximately 5 years of progressive experience in sterile product development and parenteral drug delivery

Skills, Knowledge & Abilities:

  • 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
  • Ability to travel up to 25%

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.