EXTERNAL TECHNICAL SERVICES LEAD (HYBRID)

Job Description Job Title.
External Technical Services Lead Location.
Lexington, MA About the role.
As an External Services Lead, you will manage technical support activities for Takeda Biologics Drug Substance and Drug Product at registration and post-registration stages of the product lifecycle, including troubleshooting, process improvement, cost reduction, technical transfer and validation.
You will also work with colleagues in Pharmaceutical Sciences, Supply Chain Operations, Quality Assurance and CMC-regulatory Affairs, while serving as an important point of technical contact between Takeda and multiple contract manufacturing organizations.
You will report to the Head of External Technical Services.
How you will contribute.
Ensure manufacturing readiness by managing process-related lifecycle management projects, CAPAs, and change controls.
Support product release by managing process-related deviations and resolving major process-related manufacturing issues.
Ensure process robustness by managing process data, analyzing unfavorable trends, and identifying and prioritizing corrective actions.
Align business targets with process performance.
Maintain a state of compliance by authoring process-related sections of PQR, supporting health authority interactions, and maintaining training.
In alignment with Takeda Leadership Behaviors, build relationships with partners within the External Supply Operations Team (i.
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Quality Assurance, External Supply Operations Lead, etc.) and other internal/external partners.
Facilitate program decisions by identifying guiding principles, potential options, relevant considerations, recommendations, potential outcomes and associated mitigations.
Manage, and analyze manufacturing process data.
Communicate implications to cross-functional audiences, influencing others to reach data-drive conclusions.
Curate development, validation and regulatory documents and ensure that main information is readily accessible to partners.
What you bring to Takeda.
Requires a degree in technical / scientific education with 15 years technical industry experience in development and/or manufacturing.
Experience in the GMP environment, and regulatory affairs.
Experience managing technical capabilities in a global capacity.
Experience in managing budgets, resource allocation and project portfolio management.
Potential domestic and international travel (~20%).
High level of in-depth technical expertise in techniques used in pharmaceutical sciences, such as cell culture, purification, formulation, and aseptic fill/finish.
Knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and other Regulations.
Applied Statistics experience to support process understanding and troubleshooting (e.
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JMP, Minitab, etc.).
Experience in global product launches and the associated CMC regulatory requirements.
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.
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/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 #LI-Hybrid 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.
Lexington, MA U.
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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.
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based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s.
U.
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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.
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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.