Associate Scientific Fellow / Senior Scientist, Drug Substance Program Lead, Process Chemistry

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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Process Chemistry Development (PCD) is responsible for the development of robust, sustainable, and cost-effective processes for the manufacture of new synthetic molecule pharmaceuticals, along with methods for achieving and controlling high standards of purity and quality. Our team is looking for a highly motivated individual ready to join our Cambridge-based team of Process Chemists and Engineers as we seek to discover innovative solutions to manufacturing challenges.

As a Associate Scientific Fellow / Senior Scientist, Drug Substance Program Lead, Process Chemistry Development within PCD, you will be a recognized technical leader and will possess a deep knowledge of process chemistry development for synthetic molecules. You will be key to driving advancement of the technical aspects of the portfolio by developing and executing on complex scientific strategies, overseeing internal and external efforts and potentially leveraging personal laboratory effort as well.

You will have full accountability for all technical chemistry aspects for one or more pipeline projects and will lead/participate in multidisciplinary technical teams. You will promote the department through driving strategic thinking and will be empowered to push the boundaries of synthetic chemistry to innovate in drug development.

How you will contribute:

• Develop project technical strategy and leverage technical skill(s) as a resource/expert within the department.

• Make significant independent contributions to complex/multiple projects or functional areas through leading or influencing others.

• You will have full accountability for all chemistry aspects for one or more pipeline projects and will be responsible for managing key vendor relationships across said projects.

• Will be responsible for preparing and coordinating completion of technology transfer documentation, CMC sections of regulatory documents, validation plans and reports within expertise for review.

• Leverage cross functional knowledge to guide pharmaceutical sciences teams on potential impact of actions across projects, particularly in regard to technical and strategic aspects of drug development.

• Contribute significantly to develop, drive and set vision and direction of departmental scientific and strategic initiatives.

• Identify topics for initiatives and lead local/global initiatives on behalf of senior staff.

• May have direct reports.

Minimum Requirements/Qualifications:

• A Ph.D. degree with 3+ years (7+ for ASF) pharmaceutical industry experience; an MS degree with 9+ years (13+ for ASF) of pharmaceutical industry experience; or a BS degree with 11+ years (15+ for ASF) of pharmaceutical industry experience.

• Extensive experience in synthetic organic chemistry and in process development of synthetic small molecules.

• Experience as a project leader for synthetic molecule process discovery and development.

• Sound knowledge of current Good Manufacturing Practices (cGMP).

• Experience authoring CMC sections of regulatory documents is a plus.

• Experience working cross-functionally with Process Engineering is a plus.

• Previous experience with the use of contract facilities and managing technical transfers is a plus.

• Experience introducing novel synthetic/manufacturing technologies into a GMP setting is a plus.

• Experience in working in a multi-disciplinary team environment.

• Significant technical and strategic leadership and accomplishment

• Familiarity with the use of process analytical technologies (FT-IR, NIR, FBRM, UV-vis, etc.).

• May require approximately 10% travel.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• 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 and company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time