Job Title: Associate Director - Global Manufacturing Sciences (GMSci) - Small Molecule
Location: Cambridge , MA
About the role:
- The Associate Director, Global Manufacturing Sciences (GMSci) is responsible for managing technical issues relating to the global internal and external manufacturing of commercial Drug Substance. The focus for this position is to provide technical leadership within GMSci, Drug Substance group for the management of small molecules.
- The individual will be responsible for robust process for commercial manufacturing of drug substance, process design, optimization, scale-up, technology transfer, validation and maintaining the Life-Cycle of the product.
- The individual will lead to resolve technical issues relating to a product line or major technical projects within GMSci. The individual will be a part of a small group (internal and external) of CMC team to manage technical programs and supporting contract manufacturing organizations.
- Additionally, the candidate will provide technical leadership on individual key technical projects in support of Takeda products.
How you will contribute:
- Provide direct leadership for day-to-day technical activities for Takeda's commercial drug substance manufacturing -i.e., trouble shooting, process changes and improvements, new manufacturing technology implementation, process analytical tools, statistical analysis using software such as JMP etc.
- Must have working knowledge of phase appropriate CMC development throughout the drug development which includes understanding and implementation of "Process Performance Qualification (PPQ)/Validation" strategies and protocol development and implementations.
- Lead and act as the primary interface on technical issues between GMSci, OpU, and third-party drug substance manufacturers and with Takeda's quality (QA and QC), compliance, and supply chain group.
- Lead the exercise in the compilation and analysis of production data, such as IPC, release, DoE, and manufacturing process information relating to Takeda's small molecule product portfolio to improve the quality and ROIs on the projects.
- Lead discussions on the presentation in multi-disciplinary meetings (QA, QC, Drug Product, compliance) of manufacturing data summary to improve manufacturing efficiency.
- Must have the knowledge and phase appropriate implementation strategies of QbD during Life-cycle management of the product.
- Must have knowledge and understanding of current ICH guidelines and related industry practices such as ISO.
- Author pertinent SOP's and manufacturing process instructions.
- Direct and provide technical leadership on Change Controls, investigations, and CAPAs. This would include writing the appropriate justifications to close out any investigation(s) and CAPAs implementation both internally and externally.
- Lead critical technical projects relating to the manufacturing of Takeda commercial drug substance.
- Author and review relevant dossier sections related to commercial manufacturing submissions and relevant process knowledge documentations.
- Identify, and test, strategies to reduce manufacturing risks and maintain the product Life-cycle management.
- Manage/Supervise interns, contractors and FTE's, as appropriate.
What you bring to Takeda:
- The candidate should have a BS in chemistry, chemical engineering or other scientific discipline and 12+ years of experience or MS with 10+ years of experience or PhD with 8+ year's experience working in commercial pharmaceutical/chemical industry.
- The ideal candidate should have had direct management experience with external Contract Manufacturing Organizations
- The candidate should have a good working knowledge of cGMP manufacturing operations, and/or drug substance manufacturing with experience with small molecule, preferred.
- The preferred candidate will also have a background in QA or other industry relevant background. The candidate needs to have working knowledge of CMC regulations, cGMP, and ICH guidance's.
- The candidate should have working knowledge of process qualification for "Accelerated/Fast Track" and "Breakthrough designation" programs.
- The candidate should have an advanced knowledge in Excel as well as other Microsoft Office suite software. Other analytical software usage such as JMP or MATLAB is also preferred.
- The candidate should have working knowledge and understanding of DoE and QbD etc.
- The candidate should have demonstrated written and oral communication skills and ability to work in a cross functional team environment.
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and company match of charitable contributions
- Family Planning Support
- Professional training and development opportunities
- Tuition reimbursement
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
- Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This posting excludes Colorado applicants.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations
Boston, MA Worker Type
Employee Worker Sub-Type
Regular Time Type