Manufacturing Manager
Lexington, MassachusettsOn the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:
- Small Molecules
- Biologics
- Plasma
- Cell and Gene
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
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Job Description
Job Title: Manufacturing Manager
Location: Lexington, MA
About the role:
Reporting to the Manufacturing Department Head, the value stream manager is responsible for the following:
- Hire, manage supervisory and operations staff for sustaining 24-7 operations for MABioOps manufacturing operations
- In collaboration with department heads schedule production activities to support the MABioOps manufacturing schedule
- Accountable to implement Safety CAPAs and quality systems such as CAPA, Change Controls and own process improvements for the department in collaboration with area management, Engineering, Technical Services and other support responsibilities
- Represent Manufacturing in important projects (e.x. capital projects, tech transfers, kaizen events, shutdown etc.). Collaborate with support tasks to achieve projects accurately and within established timelines
- Collaborate with support groups and area management to ensure training program is efficient
- Primary representative for department during audits and inspections. Accountable for implementation of regulatory commitments
- Support deviation assessment, investigation root cause analysis and development of CAPA plans
- Lead continuous improvement projects identified through visual management system in partnership with area management
How you will contribute:
- Represent Manufacturing in important projects (e.x. capital projects, tech transfers, kaizen events, shutdown etc.). Collaborate with support departments to finish projects accurately and within established timelines.
- Collaborate with area management, Engineering, Technical Services and other support functions to improve manufacturing process, improve projects and training.
- Coordinate routine and non routine suite activities related to manufacturing schedule.
- Support schedule & governance meetings.
- Provide support for Safety CAPAs and quality systems such as CAPA, Change Controls and own process improvements across shifts.
- Participate in facility and process inspections by domestic and international regulatory agencies.
- Staff positions.
- Ensure staff development plans are in place and routine development discussions are held.
- Establish individual goals in accordance with site goals.
What you bring to Takeda:
- Bachelor's degree in Engineering or Physical Sciences and 6 years industry experience or an equivalent level of education and/or related experience
- Prior management and supervisory experience
- Cross-functional experience with focus on project management and execution of moderate to complex tasks
- Strong comprehension of value-based production improvements
Key Skills, Abilities, and Competencies
- Operational knowledge of GMP processes and general biopharmaceutical production environment
- Knowledge of cGMPs and applicable agency regulations (such as FDA, EMA)
- Must be able to collaborate with and understand the needs of customers, stakeholders, and support functions in order to work and achieve alignment.
- Works on problems with diverse scope where analysis of data requires evaluation of identifiable factors
- Independently and collaboratively works on projects of moderate
- Solicits input from other functions as required to facilitate decisions. Acts as the point person for issues related to process and equipment and technology transfers
Other Job Requirements
Must be physically able to complete facility access and GMP gowning requirements
Will be provided company issued phone and be on-call based on standard escalation process for issues related to manufacturing, compliance and safety.
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.
#GMSGQ #ZR1 #LI-MA1
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:
USA - MA - Lexington - BIO OPSU.S. Base Salary Range:
$108,500.00 - $170,500.00The 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-termincentives. 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.
Locations
USA - MA - Lexington - BIO OPSWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWorking at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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