Job Description

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Job Description

Job Title: Associate Director of Upstream Manufacturing Sciences

Location: Lexington, MA

About the role:

As an Associate Director of Upstream Manufacturing Sciences, you will lead the Upstream Process Sciences group and provide technical and scientific leadership to support commercial and clinical production of biologics including on the floor manufacturing support, troubleshoot process issues; evaluate process data. You will provide technical leadership and main project deliverables for early to late stage clinical/commercial Tech Transfer projects. Identify, design, and improve projects of impact and complexity for enhanced manufacturing operations for improved Life Cycle management, yield and lowered costs. You will also contribute as an important member of multiple teams and partner with other departments including MS Downstream Process Sciences and MS labs, MS Data and digital, Quality, Supply Chain, Engineering, Pharmaceutical Sciences and global teams including Regulatory Affairs, CMC and Global Manufacturing Sciences. You will report to the Head of Manufacturing Sciences Biologics.

How you will contribute:

• Lead and mentor a team.
• Daily upstream process monitoring, incident response and containment, frequent interaction with upstream process sciences for full end-to-end manufacturing operations comprehension.
• Provide Subject Matter Expert support and technical leadership for investigations.
• Guide upstream process improvement programs both for short-term and long-term process health.
• Lead the implementation and improvement of Standard Work system.
• Help communication between MS functions, manufacturing and other Center function areas.
• Health Authority audit support.
• Ensure routine MFG support are accomplished smoothly.
• Monitor upstream production process performance.
• Provide support to floor operations, protocol execution, and training of manufacturing staff.
• Troubleshoot process deviations to understand the possible causes from a scientific perspective.
• Develop a technical training program to improve the technical capability of MFG and other function groups.
• Develop technical road map for process improvement programs for commercial products to improve yield and process robustness.
• Work with digital and data analytics and the single use team for process transformation to digital manufacturing.
• Work with global departments on initiation tasks, updates and LCM programs.
• Support clinical program tech transfer and site to site transfer of commercial programs as the receiving and the sending site.
• Provide expert input to departmental and senior management towards making strategic & functional decisions
• Become the subject matter Process Sciences expert within Biologics Operating Unit and Regulatory CMC.
• Provide support to CMC strategy development covering the aspects.
• Input into and translation of CMC strategy into applicable goals for Manufacturing Sciences.

What you bring to Takeda:

• BS in Chemical/Biochemical Engineering or Chemistry with 12+ years, MS with 10+ years, or Ph.D. with a minimum of 6 years of process development / manufacturing experience with mammalian downstream of recombinant proteins.
• Record of technical leadership in mammalian downstream.
• Expertise in tech transfer.
• Experience with regulatory inspections, filings, and query responses.
• Technical leadership and experiences in biopharmaceutical processing in the area of downstream.
• Have knowledge of cGMP and commercial operations.
• Limited project-specific travel may be required for evaluation of new equipment. Periodic weekend call-in coverage. May require on-site assistance if warranted.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

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