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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.

Join Takeda as Associate Director, Process Chemistry Development where you will be responsible for the development and execution of innovative processes for the manufacture of new synthetic molecule APIs focused on the core pillars of robustness, cost-effectiveness, and environmental sustainability. You will also will be responsible for providing scientific expertise and leadership by delivering well-developed chemistry solutions critical to advancing the company's development pipeline. As part of the Process Chemistry Development team, you will report to Takeda MA regional site head of Process Chemistry Development.

Takeda Process Chemistry Development is a global organization. You will work closely with our process engineering, analytical development, drug product development, and emerging manufacturing technologies teams to create and implement stage-appropriate solutions for the creation and development of routes and processes for the manufacture of synthetic molecule drug substances.

How you will contribute:

As Associate Director, you will be responsible for providing scientific expertise and leadership by delivering well-developed chemistry solutions critical to advancing the company's development pipeline. You will help grow our internal and external capabilities in synthetic molecule drug substance process development. You will manage your team 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 your technical expertise across multiple projects, maintain expertise by benchmarking current industry trends in process chemistry, and drive the optimization of departmental operational procedures. You 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 API 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)

• Contribute to develop, drive and set vision and direction of departmental activities, management of resources, time, personnel and financial resources.

• Develop and manage strategies for process chemistry infrastructure, resources, projects, outsourcing, etc. in conjunction with senior staff.

• Serve as a technical resource to guide group members in strategic decision-making and conduct analysis of technical and conceptual risk; identifies and champions operational processes and mitigation strategies.

• Monitor industry trends and recommends and implements new technologies and innovations to deliver upon process chemistry goals.

• Develop /departmental plans/initiatives and drives strategy and implementation for process chemistry, creating linkages with strategies of other relevant functions.

• Manage aspects of department performance, personnel issues, and effective communication within group and with the company as directed by senior staff.

• Provide technical /departmental leadership by fostering development of skills among staff, and providing guidance on project leadership and cross-functional awareness

• May support one or more pipeline projects and have accountabilities for the development of processes, and the management and performance of the associated internal and external project teams.

• Lead CMC sub teams and/or other cross functional teams

• Contribute to cross-departmental strategy and identifies topics for initiatives and lead local/global department and cross-department initiatives with accountability for performance and results. Communicate efforts with senior management of other functions.

Minimum Requirements/Qualifications:

• Bachelor's degree in chemistry, and 15+ years relevant pharmaceutical development experience

• Masters degree in organic chemistry or related field, and 13+ years relevant pharmaceutical development experience

• PhD in organic chemistry or related field, and 7+ years relevant pharmaceutical development experience

• 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

• Technical and strategic leadership experience with direct accountability for managing a team of direct reports is desirable.

• Experience in working in a multi-disciplinary environment with accountability for informing departmental or functional strategy.

• Experience leading functional regulatory strategy is desirable

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