Associate Director, Drug Product and Device

Technical Operations San Francisco, California


Description

Position Description:  

The Associate Director, Drug Product and Device will manage the development and implementation of parenteral Drug Product supply at Contract Manufacturing Organizations with a focus on pre-filled syringe and other devices/combination products. The position will collaborate with internal teams, consultants, development organizations, CMOs, and suppliers to support this key function for the organization.

Key Responsibilities Include: 

  • Executes process development strategy and timeline 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.
  • Manage the development of products to be administered via pre-filled syringe, including selection of syringe components, development of external sterilization process, and manufacturing at Contract Manufacturing Organizations (CMOs).
  • Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal teams.
  • Plan and organize manufacturing schedules with 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 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 and appropriate.
  • Other duties as required.

Required Experience & Qualifications:

  • Degree in life sciences / engineering or related field.
  • At least 10 years of progressive experience in cGMP manufacturing and development of parenteral products.
  • Experience with pre-filled syringes and/or other drug delivery devices required, including knowledge of the increased regulatory complexity of these products.
  • 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 25%).

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.