Associate Director, Process Scientist

Technical Operations San Francisco, California


Description

Position Description:

Contribute and lead cross-functional drug substance development teams, drive technical strategy, provide and devise innovative and phase-appropriate technology solutions. The Incumbent will have a broad range of experience with synthetic processes to guide teams toward creative and innovative solutions. Execution of internal and outsourced Drug Substance chemistry activities spanning pre-clinical research, clinical program development, and will oversee key c-GMP regulated activities from initial feasibility, technology transfer, scale-up, and validation. 

Key Responsibilities Include:

  • Independently authors technical reports, regulatory filings, and actively participates in cutting edge scientific conferences.
  • Conveys information and makes recommendations on scientific issues to senior management.
  • Develops technology and process knowledge to deliver multi-kilogram quantities of drug substance candidates.
  • Serves as a technical expert and maintains a deep understanding of peptide and conjugation chemistry technologies in compliance with current and emerging regulatory requirements (FDA, EMA, ICH, etc)
  • Lead/Support technical transfer of intermediate or API processes.
  • Conduct phase appropriate risk assessment and implement mitigation strategies to minimize risk .
  • Employ QbD and DoE principles for process development.
  • Support PAR studies and pre-validation and validation activities for drug substance.

Required Experience & Qualifications:

  • Doctorate degree in Chemistry, Biochemistry or a related life science field or Masters degree with equivalent experience
  • Working experience with approximately 4 years in a GMP environment (Pharmaceutical or Biotech industries) with working knowledge in analytica peptide and conjugation chemistry
  • Passion for learning, creating, relating, communicating, and leading cross functional teams.

Preferred:

  • Doctorate degree in Chemistry, Biochemistry or a related life science

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. 

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.