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Associate Director, Product Development

Aimmune is recruiting for a talented and energetic individual to lead and manage early stage product development efforts in close collaboration with R&D.  The job functions include directing formulation and process development activities, sourcing of appropriate suppliers for raw materials, identifying and developing contract manufacturing, testing, and packaging organizations for producing development lots and clinical trial materials (CTM).    The AD, Product Development will contribute to the overall success of developing treatments for food allergies, by translating R&D concepts into a sustainable cGMP manufacturing environment with due consideration to business, technical, and regulatory/quality risks.  Success requires working closely with R&D, Clinical, Analytical Development, Supply Chain, Quality Assurance, and CMC Project Management to ensure product development efforts are in-line with the program requirements.    Prior experience in early stage drug product development, raw material sourcing, and the demonstrated ability to work effectively in a virtual contract manufacturing environment are requirements for this position. Responsibilities  Serves as a key chemistry, manufacturing, and controls (CMC) member responsible for developing clinical stage drug products Works closely with R&D and clinical sciences to develop product specifications and requirements Works with contract manufacturing organization to develop robust, stable formulations for products in development Identifies and develops phase-appropriate equipment, processes and procedures to produce and supply the product meeting cGMP guidelines Participates and works withcontract manufacturing and test organizations to produce clinical trial products Works closely with QC/analytical teams to define testing strategy and specifications Supports contract negotiation and implementation of product development / service contracts Prepares and plays an integral part to develop regulatory filings such as Investigational New Drug (IND) and IMPD applications Qualifications BS or MS in engineering, sciences or relevant discipline, with 10+ years of biopharmaceutical experience in an early and late stage product development environment Good working knowledge of cGMP requirements including FDA and EU guidelines as they relate to early stage clinical product development Prior involvement in developing, negotiating, and implementing development contracts to include supply and quality agreements is desirable Experience working withCMOs in a virtual environment to produce clinical supplies Ability to travel up to 20% of the time Special skills/knowledge: Detail-oriented with good organizational and project management skills Self-starter with demonstrated ability to deliver high-quality results in a fast-paced development environment with minimal supervision Solid proficiency in technical writing and verbal communication skills Excellent cross-functional team participation and problem-solving skills Adept in computer skills with expertise in MS office programs and statistics-based tools About Aimmune Therapeutics, Inc. Aimmune Therapeutics is a clinical-stage biopharmaceutical company founded to address the unmet medical need in food allergy, which currently has no approved treatments. Our mission is to improve the lives of people with food allergies, based on our proprietary desensitization treatments in development. Aimmune's lead investigational drug, AR101 for peanut allergy, is in Phase 3 clinical testing in North America and Europe with plans to submit a U.S. regulatory filing for marketing approval of AR101 by the end of 2018. The company also plans to begin clinical testing of its investigational drugs for egg allergy and walnut allergy. Headquartered in Brisbane, California - the heart of San Francisco's biotechnology hub - Aimmune has additional offices in the Kings Cross area of London and in Raleigh, North Carolina.  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.
Salary Range: NA
Minimum Qualification
11 - 15 years

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