Director, Head of Manufacturing Sciences Biologics

Company: Takeda Pharmaceutical
Location: Cambridge
Posted on: May 11, 2022

Job Description:

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Job Description
Job Title: Director, Head of Manufacturing Sciences Biologics

Location: Lexington, MA

About the role:

The Head of Manufacturing Sciences Biologics (MFG) oversees the management of the commercial MFG support labs (Upstream, Downstream, and Analytics) and the MFG floor support function (cell culture and purification) which supports internal biologics drug substance manufacturing operations at MA Bio Ops. The important responsibilities of the role include:

Provide strong technical leadership to product life cycle management initiatives, including 2nd generation process development as well as general process optimization iniatiatives aiming to improve productivity, yield, and robustness.
Provide strong program leadership to commercial product CMC strategy development
Provide strong leadership to support routine GMP production for Biologics process, including incident response, process monitoring, investigation support, Deviation analysis, and drug substance OOR/OOS investigations.
Drive for new technology evaluation and implementation including process analytical technology for improved process analysis, monitoring, and feedback mechanism.
Provide strong technical leadership to clinical tech transfer into MBO facility and commercial tech transfer out ot other facilities
An effective leader in briging MBO with PS functions, including biologics upstream, downstream, and analytical development functions. An visionary leader driving for long range planning for MBO.
A strong leader in developing and mentoring managers, team lead and junior staff members for both technical and leadership development.

The Head of MFG Sciences Biologics drives and shapes an organization towards a culture of continuous improvement, innovation, and Diversity, inclusion and equity. You will partner with Manufacturing, Quality, Supply Chain, Engineering, and Regulatory Affairs to provide support of commercial and clinical drug substance manufactured at MA Bio Ops.

How you will contribute:

30% - LCM and CMC- Establish and Guide product life cycle management programs, including 2nd generation process development and general process optimization programs aiming to improve productivity, yield, and robustness. Align with CMC and Product operation team for strategy and prioritization.

5% - New technology- Establish and achieve new technology for development at MFG including PAT.

15% - MFG support- Lead routine GMP production support for Biologics process, including incident response, process monitoring, investigation support, Deviation analysis, and drug substance OOR/OOS investigations

15% - Tech transfer and new technology- Provide receiving site technical leadership to clinical tech transfer into MBO and sending site technical leadership to commercial tech transfer out of other facilities

5% - RA support- Support regulatory filing, RTQs as reviewer and approver, and support regulatory inspections including PAI and routine GMP inspection.

30% - Dept. and Personnel management-

Manage the manufacturing Science biologics group; Mentor junior staff members to build an efficient team.

Plan project prioritization, resource allocation and dept. budget.

Establish cross training and career development opportunities for team members

Support overall MFG Sciences organization to achieve a cohesive MS team at MBO.

What you bring to Takeda:

Minimum of BS Degree in Science or Engineering with 10+ years of relevant experiences and 7+ years in a leadership/managerial position
Record of technical leadership in biologics upstream/downstream process development areas, in particular late-stage process development, process characterization and validation. Influence, motivate, and guide technical process. Someone with experience in development would be.
Expertise in QbD principles and QbD-based process design pro.
Expertise in CMC strategy development, regulatory filing support (BLA filing and RTQs), and inspection support.
Record of a team leader driving for continuous improvement; Built, coached, and developed a collaborative and productive team
Develop staff with the ability to foster an open and collaborative mindset with our teams and external collaborators (other responsibilities and vendors)
Technical leadership in biologics process development and optimization in cell culture and purification.
Knowledge in CMC strategy and regulatory support responsibilities (BLA, RTQ, PAI)
Knowledge of cGMP and MFG operations.
High level of customer orientation.
Excellent verbal, written, organizational and communications would strive, in this role.

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
Professional development opportunities
Tuition reimbursement

Important Considerations:

At Takeda, our patients rely on us to provide 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.

You may:

Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas.
Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hour(s).
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.

This posting excludes Colorado applicants.

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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
USA - MA - Lexington - BIO OPS

Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time

Keywords: Takeda Pharmaceutical, Cambridge , Director, Head of Manufacturing Sciences Biologics, Executive , Cambridge, Massachusetts