Associate Director, Drug Product Development - Vaccine BU

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ASSOCIATE DIRECTOR, DRUG PRODUCT DEVELOPMENT - VACCINE BU

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Drug Product Development - Vaccine BU in our Cambridge, MA office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.

OBECTIVES:

- Direct and oversee the optimization, characterization, scale-up of Drug Product manufacturing processes from the R&D laboratory stage through to Commercial production.

- Direct pre-formulation and formulation activities to support VBU’s pipeline

- Provide professional information, input, and review as needed for global regulatory agency submissions.

ACCOUNTABILITIES:

- Design, test, transfer, and oversee validation of unit operations for manufacture of Final Drug Product (FDP). Operations include, but are not limited to, complex aseptic formulation, solubilization and filter sterilization of solutions, continuous mixing, and fill finish into vials and/or prefilled syringes.

- Oversee small scale and commercial scale lyophilization studies, time in solution studies, potency targeting models and shelf-life fill models in multiple images (single dose and multi-dose images).

- Manage off-site CMO’s for various aspects of FDP manufacturing including authoring and reviewing of Batch Records/Master Production Records specific to unit operations, reagent acquisition, raw material specifications, transfer of in-process analytical testing methods, and person-in-plant for GMP activities.

- Develop and test formulations to improve product stability, facilitate manufacturing processes, prolong shelf life, and set product specifications.

- Design and implement protocols for technical evaluation of product-related devices, e.g., bulk Drug Substance and FDP storage containers/contact surfaces and Drug Product delivery devices.

- Design and implement protocols for drug product stability studies, both long-term and accelerated conditions.

- Coordinate product and process characterization studies off-site with various CMOs and prepare reports for global regulatory submissions.

- Author and review CMC documentation, including technical and quality sections, for submission to regulatory agencies, e.g., IND, CTD.

- Participate and, as applicable, make presentations in both internal and external technical reviews, including regulatory discussions. Other duties as need

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

• PhD in Chemistry, Pharmaceutics, or Life sciences with a minimum of 8 years in pharmaceuticals, biologics or industry experience, or an MS in Chemistry, Pharmaceutics, or Life sciences with a minimum of 12 years in pharmaceuticals, biologics or industry experience.
• 5 or more years of leadership experience.
• 5 or more years experience in Drug Product Development.
• Experience in a GMP manufacturing environment would be preferable.
• Exposure to all aspects of the R&D process.
• Knowledge of GMPs and CMC regulatory requirements concerning drug development.
• Experience in late-phase and commercial process development, tech-transfer, scale-up, process optimization, and validation.
• Demonstrated technical proficiency, scientific creativity, collaboration with others, and independent thought in suggesting experimental design and research strategy.
• Ability to recognize anomalous and inconsistent results and interpret experimental outcomes.

PHYSICAL DEMANDS:

• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
• Typical office and laboratory bending, stooping, lifting requirements apply.
• Lifting and moving supplies and equipment (up to 50 pounds).

TRAVEL REQUIREMENTS:

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
• Requires approximately 20% travel.

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days

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