Senior Director, Drug Substance Manufacturing

Technical Operations San Francisco, California


Description

Position Summary:  As part of the Technical Operations senior leadership, the Senior Director, Drug Substance Manufacturing, will assume overall accountability of the newly created area of commercial manufacturing to grow the organization to meet future commercial Drug Substance demand.  He/she will bring deep and diverse expertise in manufacturing areas and work with internal and external partners to design and build an organizational structure for a sustainable future.  Steering discussions around continued growth in the commercial manufacturing area include robust external sourcing and planning to support Apellis’s exponentially growing portfolio.

Key Responsibilities Include:

  • Establish strategic leadership for commercial manufacturing, partnering with leaders in the Technical Operations and holding overall accountability for commercial Drug Substance (DS) supplies of current and future portfolio
  • Oversee functional leadership for activities such as DS demand planning and projections, translating demand projections to manufacturing schedules, coordinating external manufacturing, leading and participating in manufacturing related governance
  • Ensure manufacturing processes are validated and maintained in a state of compliance with applicable cGMP and global health regulations
  • Collaborate with investigational manufacturing organizations and contribute to essential elements of scale-up and state-of-the-art technology implementation leading to a successful process re-validation and a robust commercialization of subsequent generation processes
  • Develop and execute integrated plan and roadmap to meet commercial demand for Apellis’s portfolio
  • Build newly created organizational systems, processes and governance
  • Partner with cross-functional stakeholders (QC, QA, Commercial, Clinical and Regulatory) to enable tech transfer of manufacturing and regulatory processes
  • Ensure successful management of external vendor relationship. Participate in external vendor due diligence audits
  • Support needs of clinical development and timelines
  • Develop operational and organizational priorities and hiring plans
  • Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal departments (R&D, Regulatory Affairs, Quality Control and Quality Assurance) to ensure achievement of corporate objectives

Required Experience & Qualifications:

  • Extensive experience in commercial manufacturing and planning
  • Knowledge of pharmaceutical processes and systems along with significant development, scale-up, validation and manufacturing
  • Proven track records of staff management, team development and management experience
  • Knowledge in optimization, manufacture and analysis of peptides and peptide related substances is desirable
  • Demonstrated ability to lead people and get results through others
  • Ability to communicate effectively and document scientific and technical studies and associated results
  • PhD. in Chemistry or related areas
  • 15+ years of progressive experience in cGMP development and manufacturing with minimum of 10 years managing CMC functional areas
  • Exposure to interacting with regulatory agencies
  • Experience with writing and reviewing contents for INDs, NDAs and MAAs
  • Excellent technical computer skills, communication, comprehension, interpretation, problem solving, team spirit, critical thinking and organization skills
  • Must have valid passport and must be authorized to work in the USA

Working Conditions: May require travel to Company’s CMOs 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.