Senior Scientist, Drug Product Development (DPD)
Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.
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Senior Scientist, Drug Product Development (DPD)Apply Now
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Scientist, Drug Product 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.
The Senior Scientist is expected to provide technical leadership on product development activities encompassing different modalities including small molecules, microbiome, oligonucleotides and peptides. The Senior Scientist is responsible for independently planning and execution of drug product development activities including Drug Discovery support, Pre-formulation, Formulation/Process Development, Tech Transfer, Clinical Manufacturing and Regulatory Filing supports. He/She may represent line function on Pharmaceutical Sciences teams and will provide theoretical/conceptual input to the design, development and execution of research assignments for drug product development.
Designs, executes and/or manages phase appropriate formulation and process development studies encompassing all activities from early phase formulation to manufacturing process validation with inputs from manager as needed.
Manage CROs and CMOs to support drug product development and GMP manufacturing of the drug product.
Responsible for drug product manufacturing activities at CMO’s including master batch records, protocols GMP manufacturing, batch release, deviations, investigations, CAPA’s and change controls.
Author/review internal development reports, CMC sections of IND/IMPD/NDA and responses in support of regulatory filings/queries.
Represent DPD group on cross functional CMC teams and leverage strategic understanding of the project and CMC priorities to plan/coordinate the drug product development studies with cross-functional peers.
Provide project progress updates/reports to manager to ensure management is engaged and aware of the project strategy, current activities and future needs.
Serves as subject matter expert and contributes actively to complex/multiple projects or functional areas through leading or influencing others.
Lead and support departmental (or cross functional) key initiatives to drive scientific and technical innovations.
Ensures a productive, respectful and development-rich environment; provides training/mentoring for junior staff.
Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Must have a degree in a related scientific discipline. BS with at least eleven (11) years, MS/PharmD with at least nine (9) years or a PhD with a minimum of three (3) years of experience in Product Development in the Pharmaceutical industry is required.
Extensive experience and demonstrated track record in several drug product development activities such as Drug Discovery support, Pre-formulation, Early phase formulation development, formulation characterization, manufacturing process development, tech transfer, scale up and validation.
Technical expertise in development of oral or parenteral products with demonstrated experience in one or more formulation techniques including but not limited to solubilization, spray drying, hot melt extrusion, nanoparticles, dry/wet granulation, tablet compression, Wurster process, tablet coating, encapsulation, liquid fill/finish and aseptic processing.
Good working knowledge of common analytical techniques such as HPLC, DSC, TGA, XRPD, IR/Raman spectroscopy and particle size analysis techniques.
Extensive experience in CMC pharmaceutical development for drug products under cGMP’s.
Previous experience contributing to regulatory filings.
Ability to work independently, take initiatives, and complete tasks to meet the deadlines.
Strong team player.
Must be capable of handling multiple projects with competing timelines and must be able to make complex decisions.
Must possess solid communication skills as well as organizational skills.
Demonstrated leadership skills – Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.
Hands-on laboratory work is required
Requires occasional travel to various meetings or vendor sites. Some international travel may be required.
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
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
*This job posting excludes CO applicants*
Time TypeFull time
Job ID R0031058