Director, Head of Manufacturing Sciences Biologics
Company: Takeda Pharmaceutical
Location: Cambridge
Posted on: May 11, 2022
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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.
#GMSGQ
#ZR1
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
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