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, Process Chemistry & Development 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.
Process Chemistry & Development (PCD) department is responsible for the development and execution of robust and cost-effective processes for the manufacture of new small molecule DS, along with methods for achieving and controlling high standards of purity and quality, throughout the entire development lifecycle.
The successful candidate for an associate director within the process chemistry department will manage staff with accountability for performance and results including: the development and characterization of chemical processes, technical transfer to CMOs, oversight of cGMP manufacture, and representation on CMC teams. As a leader within the process chemistry department, the successful candidate will contribute his/her technical expertise across multiple projects, maintain expertise by benchmarking current industry trends in process chemistry, and drive the optimization of departmental operational procedures. Associate Director, Process Chemistry & Development will also be expected to contribute to and drive both line function and cross-functional strategy and lead teams with accountability for performance and results.
Assure technical deliverables for DS projects under personal and team direction (process development work captured in technical reports, tech transfer and cGMP productions, process characterization consistent with QbD principals, and process validation as appropriate)
Contributes significantly to develop, drive and set vision and direction of departmental activities, management of resources, time, personnel and financial resources.
Develops and manages strategies for process chemistry infrastructure, resources, projects, outsourcing, etc. in conjunction with senior staff.
Serves as a technical resource to guide group members in strategic decision making and conducts analysis of technical and conceptual risk; identifies and champions operational processes and mitigation strategies.
Monitors industry trends and recommends and implements new technologies and innovations to deliver upon process chemistry goals as appropriate.
Develops discipline/departmental plans/initiatives and drives strategy and implementation for process chemistry, creating linkages with strategies of other relevant functions.
Manages aspects of department performance, personnel issues, and effective communication within group and with the company as directed by senior staff.
Provides technical /departmental leadership by fostering development of skill sets among staff, and providing guidance on project leadership and cross-functional awareness
Leads CMC sub teams and/or other cross functional teams
Contributes to cross-departmental strategy and identifies topics for initiatives and leads local/global department and cross-department initiatives with accountability for performance and results. Communicates efforts with senior management of other functions as appropriate.
EDUCATION, EXPERIENCE AND SKILLS:
Education and Experience:
Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 15+ years relevant industry experience
Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 13+ years relevant industry experience
PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 7+ years relevant industry experience
PhD-level academic research in organic chemistry or related field; or substantial industrial organic chemistry lab-based research experience
Advanced proficiency with typical analytical tools (e.g. NMR, UV, IR, HPLC)
Proficiency with utilizing typical literature searching techniques to solve organic chemistry problems
Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP's
Sound knowledge of current Good Manufacturing Practices (cGMP)
Significant relevant pharmaceutical development experience
Significant technical and strategic leadership experience with direct accountability for managing a team of direct reports.
Experience in working in a multi-disciplinary environment with accountability for informing departmental or functional strategy.
Knowledge and Skills:
Teamwork -- Ability to work well on global cross-functional teams; Proven ability to foster a highly efficient team environment.
Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use
May require approximately 15-20% travel.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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
Discover more at takedajobs.com
Takeda Pharmaceutical Company Ltd