Manager, Drug Substance

Technical Operations San Francisco, California


Description

Position Description:  The Manager, Drug Substance (DS) will manage Drug Substance supply at Contract Manufacturing Organizations (CMOs) and will collaborate with internal teams, consultants, Research and Development (R&D) organizations to support this key function for the Apellis organization. 

Key Responsibilities Include:

  • Execute process development strategy and timelines to ensure phase-appropriate manufacturing processes and methods.
  • Actively manage external development and manufacturing activities, ensuring close partnership through open and transparent communication, scientific and strategic understanding, and attention to priorities and details.
  • Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal teams to ensure achievement of company objectives.
  • Plan and organize clinical and commercial manufacturing schedules and timelines with CMOs ensuring continuous material availability for all manufacturing activities, including adequate planning for long lead time items.
  • Review batch production records and written instructions and procedures to ensure cGMP compliance and maintenance of current quality standard.
  • Review deviations, investigations and CAPAs and make recommendations to Quality Assurance.
  • Monitor CMO performance. Communicate findings, including risks and opportunities to internal stakeholders during project meetings and trigger corrective actions.
  • Use risk management, investigational techniques, root cause analysis and quality concepts in the identification and evaluation of compliance risks.
  • Review essential elements of scale-up and technology transfer leading to a successful process validation and a robust commercialization.
  • Gather knowledge as the basis for the manufacturing control strategy, the approach for process qualification and continuous process improvements.
  • Participate in various cross-functional projects as needed.
  • Support needs for Drug Product supply in development and commercial stages.

 Required Experience & Qualifications:

  • Degree in life sciences / engineering or related field.
  • At least 3-5 years of progressive experience in cGMP manufacturing and development of Active Pharmaceutical Ingredients (APIs).
  • Experience with peptide manufacturing is a plus.
  • The ideal candidate has passion for learning, creating, relating, communicating, and working in cross functional teams.

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 15%).

About Apellis: Apellis is 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.