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Supervisor, Manufacturing Ops Support (CCT) at Shire Human Genetic Therapies, Inc. in Lexington, Massachusetts

Posted in General Business 30+ days ago.

Type: Full-Time

Job Description:

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Job Description

About the role:

Primary responsibilities of the position are focused around support of daily manufacturing operations. Primary activities would generally include but not be limited to investigations and CAPA support, training coordination, document revisions, implementing continuous improvement projects, data analysis/trending, team support, coaching personnel, and training staff. This job will report to the Manufacturing Support Manager, Downstream Operations.

How you will contribute:

  • Provide subject matter expertise and data gathering for deviation investigations, safety investigations, and any manufacturing-related requests to support regulatory inspections and audits.

  • Support enhancement of Tiered board system, including development and monitoring of metrics intended to guide business process improvements.

  • Liaise and collaborate with important partners (Area Management, Quality Assurance, Quality Control, Materials Management, PIER, Manufacturing Sciences, Facilities & Engineering) as applicable.

  • Manage contingent primary team and provide development opportunities to associates.

  • Develop technical expertise and provide technical instruction on new/improved processes to appropriate audiences.

  • Communicate with team members to support data gathering requests for manufacturing investigations, e.g., obtaining copies of production batch records

  • Coordinate all area data gathering requests and manage timelines toward completion

  • Coordinate and implement manufacturing deliverables for quality system drivers, such as investigations and CAPAs.

  • Interview and select candidates for the contingent primary team

  • Provide leadership through:

    • Assess performance and make recommendations for annual programs such as Talent Review and Year End Compensation

    • Individual goal setting/performance reviews

    • Ensure appropriate staffing levels and skills are maintained

    • Manage employee performance issues and corrective actions

    • Use safe work practices and behaviors

    • Recognize and appreciate employee contributions and support workforce diversity

    • Ensure that employees are working in a safe and compliant manner.

    • Help guide support and change management

  • Will manage labor (absence, vacation, and OT) and other group expenses

  • Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMA) to ensure inspection readiness of department

  • Work in a team environment

  • Effectively communicate skills to all levels of the organization.

  • Time management skills

  • Demonstrate appropriate level of adaptability, maintain positive outlook,

  • Seek ways to improve current processes related to manufacturing and individual activities.

  • Proactively and systematically finds and applies best practices for problem solving and gap identification beyond one's comfort level. Expand problem solving abilities by assimilating new approaches.

  • Work on routine and sometimes moderately complex problems in which analysis of situations or data requires an in-depth evaluation of different factors.

  • Understanding of Takeda's business, goals, and operations and how own activities fit within company strategy.

Minimum Requirements/Qualifications:

  • Bachelor of Science degree and 3+ years related industry experience or an equivalent level of education and/or related experience is acceptable.

  • Experience as a Lead or Supervisor in a GMP Manufacturing facility required.

  • Experience in accomplishing moderate to complex schedules preferred

  • Experience with systems such as SAP, LIMS and TrackWise

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

  • Flexible Work Paths

  • Tuition reimbursement

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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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.


USA - MA - Lexington - BIO OPS

Worker Type


Worker Sub-Type


Time Type

Full time

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