Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director/Director of Process Development, Vaccines in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As an Associate Director/Director of Process Development in the Vaccines CMC organization, you will be empowered to manage process development and tech-transfer activities for clinical and commercial manufacturing . You will be managing a team at the Cambridge, MA site.:
- This position is responsible for design, development, optimization, trouble-shooting, continuous improvement, data trending and monitoring of DS process to support clinical/commercial manufacturing
- The position will lead the team in terms of strategy, planning and execution project and product deliverables under the responsibility of the Head of Process Development, the POT Lead and the Head of Vaccine Operations CMC.
- It is an expectation, to both initiate and support operational and strategic initiatives, lead and monitor ongoing internal deliverables, direct special projects, and work effectively in under the "One Team" context with our commercial manufacturing colleagues.
- Leads initiatives by the Cambridge Team for scouting new technologies for product development.
- Leads and supports the Cambridge process development team in testing the new methods and tools in house at small scale to represent the commercial process.
- Based on the "One Team' theme provides support for ongoing investigations and initiatives together with our commercial manufacturing colleagues in the External Manufacturing group.
- To ensure resource utilization in the process development group is well managed.
- Providing appropriate support, background materials, and drafts of deliverables to Head of Process Development to ensure that key projects are completed in a timely manner with high quality.
- Effectively fills gaps in information within the organization by working with other senior leaders across the organization.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- A Bachelor's degree with 15+ years of experience or a Ph.D. with 10+ years of experience, in biologics process development and manufacturing.
- At least 10 years of people management
- Ability to handle multiple priorities, build strong relationships across all levels and facilitate excellent team leadership skills.
- Ability to network externally and internally.
- Strong communication skills with a proven track record of influencing others
- Must be able to identify problems/ risks/ issues and facilitate issue resolution and risk mitigation during the course of product development.
- Experience with single-use cell culture and/or purification technologies strongly desired
- Experience with analytical methods used in support of process development strongly desired
- Experience with supporting regulatory filings, preferably BLA/MAA is desired
- Experience in downstream processing utilizing chromatography and ultrafiltration strongly desired
- Hands-on experience of validation and Biologics cGMPs including ICH guidance documents would be highly advantageous
- Excellent oral and written communication skills required
- Well organized and detail oriented, able to effectively prioritize, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility.
- Good time and project management skills, ability to oversee several projects simultaneously.
- Comply with Takeda safety practices and standard operating procedures.
- Exhibit and promote Takeda Core Competencies.
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