Senior Manager, Drug Substance

Technical Operations San Francisco, California


Description

Position Description:  The Senior Manager, Drug Substance is accountable for the development, implementation, and oversight of Drug Substance supply at Apellis’ Contract Manufacturing Organizations.  The individual will be responsible for assuring Drug Substance conforms to regulatory and company standards and satisfies GMP regulations.

Key Responsibilities Include:

  • Plan and organize manufacturing schedules with Contract Manufacturing Organizations (CMOs) ensuring consistent material availability for all manufacturing activities, including adequate planning for long lead time items
  • Review batch production records and written instructions to ensure cGMP compliance and maintain current quality standard
  • Review deviations, investigations and CAPAs and make recommendations to Quality Control
  • Oversee pilot, full-scale production, and Quality processes on-site with the CMOs
  • Monitor CMO performance. Communicate findings, including risks and opportunities to internal stakeholders during project meetings and trigger corrective actions
  • Assist in conducting CMO audits to assess and quantify their demonstrated manufacturing capabilities and capacities
  • Study and analyze process improvements to gain efficiency and increase productivity
  • 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
  • Establish and oversee organized filing of CMO documentation
  • Ensure all appropriate documents are generated and retrievable
  • Participate in various cross-functional projects as needed and appropriate
  • Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal teams
Required Experience & Qualifications:
  • Degree in life sciences / engineering or related field
  • Approximately 5 years of progressive experience in cGMP development and manufacturing
  • Strong communication skills
  • Must have valid passport

Working Conditions: May require travel to Company’s CMOs to oversee the virtual development and manufacturing network (estimated at 40-50%).

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.