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 Director/Sr. Director, Process Development and Manufacturing in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director/Sr. Director, Process Development and Manufacturing working on the Biopharmaceuticals Process & Product Development, Pharmaceutical Sciences team, you will be empowered build and lead a world class team and partner with individuals across Takeda s Pharmaceutical Sciences division and a typical day will include:
The Director/Senior Director of Process Development and Manufacturing will bring vision, strategic direction and leadership to the Pharm Sci team and deliver on building out a world-class cell culture process development function together with a NON-GMP pilot production facility for the manufacturing of toxicology materials. Additionally, the position will be responsible to nurture a development footprint of microbiome based products.
The position will work with the Head of Biopharmaceuticals Process & Product Development, Pharmaceutical Sciences and other sr. leaders to lead and direct the strategy at the interface between portfolio management, project management, and operations. The position will help drive the team s execution and proactively contribute to development strategy and translation of that strategy into action.
The position will provide leadership in ensuring that development activities are well defined, coordinated, and consistent with the overall corporate strategy. The position will also drive the development of group leader-, bench talent and overall department performance in support of the development of cutting edge products and innovative manufacturing solutions.
The position will partner with downstream, analytical, quality and regulatory leaders to ensure the clinical products are manufactured with a high degree of quality and also drive the global strategy for continuous and phase-appropriate process optimization in collaboration with customers
Strategy for the Process Development and Manufacturing capability:
- Foster a customer focused culture of high performance, out-of-the-box thinking, innovation and learning, empowerment, diversity, inclusion and trust.
- Identify talent, recruit and effectively manage a highly skilled team of scientists, managers and process engineers in upstream process development.
Engage with outside organizations and drive collaboration with academic and industry partners:
- Support collaborative relationships to advance technology development and novel manufacturing solutions
- Promote the reputation of the organization as a leader in the bioprocess development field through publication and contributions to larger industry consortia
As assigned lead Global CMC teams in successful execution of early phase CMC development internally or in collaboration with partners
- Establish and lead the CMC team focused on process development and product manufacturing for early clinical stage cell therapy programs.
- Design and develop processes in collaboration with academic and biotech partners; partner with them in the successful project execution
- Direct and indirect supervisory responsibilities in one or more scientific area for development of high quality biologic therapeutics
- Drives team to obtain scientific data ; data compilation and review; preparation and review of technical reports, regulatory filings, and other documentation; project/CMC team representation/leadership; technical interactions with internal partners and contract laboratories.
- Contributes to setting the strategy and direction for the overall global function and frequently represents the function within CMC/Pharm Sci and across the global Takeda organization.
- In collaboration with commercial functions, develop and implement strategies to control quality of drug substances and products based on the current Good /Laboratory/Manufacturing Practice
- (cGMP, cGLP) regulations.
- Manage functional area budget and human resources to be within required limits.
- Responsible for collaborating with other functions in pharmSci to encourage strategic alignment and successful achievement of shared goals.
Seamlessly interface with upstream and downstream customers, including research development and commercial
Be well versed in all stages of pharmaceutical development and understands the global regulatory trends for CMC activities, to ensure robust and high quality regulatory filings in all countries Takeda is active.
Leads global CMC key initiatives and represents PS to other cross functional stakeholder key initiatives
Analyse and synthesize concepts from diverse information and articulate\
Look for external benchmarks that help to aid superior performance of products, processes and people
Maintains an active understanding of the future trends of medicine to build an adaptable organization for the future.
Inspires confidence in team members and ensures organization culture is healthy.
Builds future leadership and while mentoring direct reports and junior employees
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
- Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 22+ years relevant industry experience or
- Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 17+ years relevant industry experience or
- PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 12+ years relevant industry experience
- 8+ years of direct industry experience in relevant development and manufacturing functional area of expertise.
- Demonstrated people and program management skills, critical and out-of-the-box thinking ability, situational leadership skills
- Demonstrated ability to anticipate issues and manage a team to proactively implement solutions.
- Experience in assuring the implementation of required quality processes and standards to facilitate smooth transition from product development to commercialization
- Experience in writing regulatory documents
- Understands the structure, functions, and methods of the global Takeda organization and overall Takeda R&D operations.
- Excellent organizational and communication skills. Has the ability to influence at all levels of the organization and manage projects across businesses and the globe.
- Demonstrated ability to negotiate difficult issues and arrive at mutually beneficial solutions
- Ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with product quality and regulatory compliance.
- Demonstrated ability to effectively lead and motivate a team of direct reports, build on strengths, and address areas for improvement.
- Proven record of building mutually-respectful relationships across global regions and companies in order to foster communication and achieve strategic goals
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.
No Phone Calls or Recruiters Please.