Senior Manager, Technical Operations, Drug Product
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 a Senior Manager, Technical Operations, Drug Product in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Senior Manager, Technical Operations, Drug Product working on the Technical Operations team, you will be empowered and a typical day will include:
Identify and plan broader technical objectives, both project-related and department wide, and initiate the development of operational processes to facilitate these objectives for future projects within Commercial Tech Ops. Work closely with, and manage, manufacturing partners to minimize supply chain risks, manage technical transfer and process validation activities, and lead life-cycle management strategies. Identify optimum path to project goals, recommend solutions to the team(s) for decision, and manage the strategies as appropriate.
- Lead technical team(s) to transfer, validate, and gain regulatory approval for new manufacturing sites
- Use excursion management systems to ensure manufacturing processes remain compliant.
- Manage relationship with CMO technical staff
- Manage CMC change control related activities
- Lead technical investigations in support of commercial manufacturing
- Prepare documentation for, and coordinate activities related to, technology transfer.
- Author, or review, CMC sections of regulatory documents, validation plans, and reports.
- Weigh and assess technical risk associated with decisions that impact outside CMC.
- Apply basic and advanced statistical concepts to process data from drug product manufacturing processes
- Define complex approaches and methodologies, some innovative and creative, to achieve project goals.
- Manage key vendor relationships across multiple projects and affect resolution of issues during, or resulting, from manufacturing.
- Initiate and influence project direction outside department.
- Use understanding of project timelines and holistic project view (e.g., impact on resources, legal, IP, across functions in Commercial Pharm Ops) to plan and coordinate with cross functional peers and evaluate impact of decisions across CMC and other commercial functions.
- Contribute to complex projects or functional area through leading or influencing others.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Demonstrate advanced understanding of chemical engineering/statistical principles as they relate to drug product manufacturing processes.
- Experience within a CMC team (CMC leadership preferred).
- Experience with technical transfer and validation of biologic manufacturing processes.
- >1 year of experience working with technical staff of CMOs.
- Outstanding attention to detail and critical thinking.
- Strong communication (verbal and written) skills are required.
- Demonstrated understanding of the connection between compliance and manufacturing.
- >3 yrs commercial manufacturing experience in drug product manufacturing operations.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Position requires less than 25% domestic and international 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
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.