Director, Product Development - CMC
Position: Director, Product Development - CMC
Reports to: Executive Director, Product Development and Manufacturing Services
Location: San Francisco Bay Area and/or Raleigh, NC
The incumbent in this position is responsible for providing direction and oversight of all technical activities associated with source material (drug substance, DS) and drug product (DP) development (process and product) supporting early stage clinical development of Aimmune’s programs in oral immunotherapy (OIT) for treatment of food allergies. This individual will work closely with internal cross-functional groups and external contract development/manufacturing organizations and suppliers to accomplish early development goals. As leader of the early stage DS/DP development team, the individual will serve as the core DS/DP team member for early stage programs. Key responsibilities include serving as a key technical resource, providing guidance to the early stage pharmaceutical development team, overseeing and managing technical activities at outside contract organizations, hiring staff, and budgeting. The candidate will work closely with Clinical Manufacturing and Supply Chain, Commercial Manufacturing and Supply Chain, Analytical Development, Quality Assurance (QA), Regulatory and Portfolio/Project Management (PM) groups. Prior experience managing technical teams and strong background in early stage product development are requirements for this position.
- Develop stable formulations over a range of dosage strengths for OIT product candidates in Aimmune’s development pipeline
- Work with PM and other internal partners to manage and track progress in the execution of technical DS and DP development strategies in support of IND filings and Phase 2/3 clinical studies
- Provide technical oversight of all the GMP activities associated with the development and manufacturing of DS, starting materials, DP formulation, and DP manufacturing process for early stage products
- Hire as necessary, mentor, and develop direct reports and other individuals within the early stage development group
- Assist in the preparation and review of CMC regulatory submissions (and responses) for USA and worldwide health agencies
- Author and/or review and approve manufacturing documents, protocols, and reports
- Provide technical support during external audits of vendors and subcontractors
- Identify required DS and DP quality attributes and work with AD to ensure development and phase-appropriate validation of required analytical methods
- Work with Supply Chain and QA to identify and select strategic contract development, manufacturing, and packaging partners for early stage programs
- Negotiate and obtain approval for Service Level Agreements and related Statements of Work for development activities at external development/manufacturing organizations.
- Create and manage project budgets.
- Support due diligence efforts with potential Aimmune partners
- Work closely with Clinical Manufacturing and Supply Chain and QA to ensure availability of clinical supplies meeting quality requirements
- PhD in Pharmaceutical Sciences or relevant technical field with at least 10 years’ experience or MS with at least 15 years’ experience
- Minimum of 5 years’ experience in managing outsourced development activities
- Proven track record of CMC leadership for early to late stage development leading to approved products in the US and/or EU
- Previous managerial experience is required. Good project management and leadership skills, with ability to lead multiple programs at the same time
- Hands-on experience in product formulation (solid oral dosage forms) and process development from early to late phase development
- Solid understanding of ICH, FDA, and EMA guidances governing product/process development and manufacture
- Good working knowledge of GMP requirements for drug product development and manufacturing.
- Experience in writing, reviewing and approving CMC sections of regulatory filings from early stage development through commercial launch.
- Experience with budget planning and budget management.
- Enthusiasm for working in a fast-paced environment within a matrix organization
- Excellent oral and written communication skills
- Ability to travel up to 20% of the time
Preferred Experience/Special Skills/Knowledge:
- Self-starter with demonstrated ability to effectively prioritize and deliver high-quality results in a fast-paced development environment with tight timelines
- Accuracy and attention to detail
- Excellent cross-functional team participation skills
- Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues in a virtual environment
- Ability to recognize and implement potential new technologies to meet Aimmune product development requirements
About Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies. The Company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies. For more information, please visit www.aimmune.com.
Aimmune is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.