Director, Technical Operations
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, Technical Operations in our Cambridge Massachusetts office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, Technical Operations working on the Technical Operations team, you will be empowered to enhance and innovate manufacturing processes and be the technical thought leader related to Takeda Oncology and Biologics products, and a typical day will include:
Manage technical issues relating to the global external manufacturing of commercial Drug Product.
Provide technical leadership within Technical Operations, Drug Product group for the management of oncology therapies drug product.
Responsible for commercial manufacturing of drug dosage forms, drug product manufacturing process design, optimization, scale-up, technology transfer and validation.
Lead to resolve technical issues relating to a product line or major technical projects within Technical Operation.
Lead a small group of Technical Operations staff to manage technical programs and contract manufacturing organizations.
Provide direct leadership for day-to-day technical activities for Takeda s oncology and biologics commercial drug product manufacturing i.e., trouble shooting, process changes and improvements, new manufacturing technology implementation etc.
Lead and act as the primary interface on technical issues between Technical Operations and third-party drug product manufacturers.
Lead the exercise in the compilation and analysis of production data, such as IPC, release, and manufacturing process information relating to Takeda s oncology and biologics product portfolio.
Lead discussions on the presentation of the above data summary to improve manufacturing efficiency.
Author pertinent SOP s and manufacturing process instructions.
Direct and provide technical leadership on Change Controls, investigations, and CAPAs.
Lead critical technical projects relating to the manufacturing of Takeda commercial oncology and biologics drug product.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
- PhD + 8-10 yrs in biopharmaceutical industry
- >1 year of experience working with technical staff of CMOs
- Experience with technical transfer and validation of drug product manufacturing processes
- Experience within a CMC team (CMC leadership preferred)
- Experience with regulatory filing preparation and regulatory interaction
- Significant experience working in an outsourcing environment
- Ability to interpret and communicate information both internally and to external suppliers
- Demonstrated advance understanding of chemical engineering/statistical principles as they relate to solid oral dosage manufacturing processes
- Strong history of technical accomplishments
- Understands the value of Process Excellence including tools such as 6 Sigma and DOE
- Outstanding attention to detail and critical thinking
- Strong communication (verbal and written) skills are required
- Demonstrated understanding of the connection between compliance and manufacturing
- Demonstrated leadership capabilities to develop a high performing team, drive change, and influence internal and external stakeholders
- Demonstrated technical proficiency, scientific creativity, and innovation individually and in collaboration with others
- Track record of managing scientific professionals, budgets, and effectively planning operations
Empowering Our People to Shine
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