BioSpace
Job Description
About the role: As the Head of Manufacturing Support, you will be responsible for leading the Manufacturing Compliance, Training, Project Management and Operations Support teams. This role oversees the development and execution of support team strategies, ensuring effective assistance to internal manufacturing operations. You will enable consistent and compliant delivery of the plan of record, which includes technology transfers and new product introductions, drives continuous improvement within Manufacturing and supports the realization of the overall manufacturing strategy. You will report into the Head of Manufacturing.
Responsibilities
Develop a comprehensive manufacturing support strategy to ensure safe, compliant and efficient MFG operations
Deliver a high level of customer service for the MFG Operations team
Lead team subject matter expertise (SME) for cGMP Manufacturing operations, technical training, investigations, quality systems management and project support
Develop MFG Training strategy to ensure flexibility and redundancy within Manufacturing operations
Cache/training of Manufacturing Support Staff
Promote internal inspection readiness of the Manufacturing Teams
Facilitate and continuously improve management systems, including development and monitoring of metrics intended to drive business process improvements
Liaise between manufacturing and cross‑functional areas as applicable
Drive the organization towards a culture of innovation, collaboration, best practice, accountability and efficiency
Qualifications
Bachelor's degree or equivalent experience in Engineering or Science and 15+ years of relevant experience in commercial biotechnology or pharmaceutical production
Strong knowledge of cGMP and other regulatory requirements related to manufacturing biologics
Ability to think strategically and realize support vision in line with overall manufacturing mission and vision
Capable of making technically sound and compliant recommendations regarding cGMP operations
Organizational effectiveness and employee development focus
Actively seeks ways to improve current systems and processes related to manufacturing and individual activities
Proactively and systematically seeks and applies best practices for gap identification
Understanding of company business, objectives, and operations and how own activities fit within company strategy
MS Office, LIMS, SAP, TrackWise, EDMS, compliance, and strong scientific understanding
Location USA - MA - Lexington - BIO OPS
Compensation U.S. Base Salary Range: $174,500.00 - $274,230.00
Benefits U.S. based employees may be eligible for short‑term and/or long‑term incentives. 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.
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.
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.
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Responsibilities
Develop a comprehensive manufacturing support strategy to ensure safe, compliant and efficient MFG operations
Deliver a high level of customer service for the MFG Operations team
Lead team subject matter expertise (SME) for cGMP Manufacturing operations, technical training, investigations, quality systems management and project support
Develop MFG Training strategy to ensure flexibility and redundancy within Manufacturing operations
Cache/training of Manufacturing Support Staff
Promote internal inspection readiness of the Manufacturing Teams
Facilitate and continuously improve management systems, including development and monitoring of metrics intended to drive business process improvements
Liaise between manufacturing and cross‑functional areas as applicable
Drive the organization towards a culture of innovation, collaboration, best practice, accountability and efficiency
Qualifications
Bachelor's degree or equivalent experience in Engineering or Science and 15+ years of relevant experience in commercial biotechnology or pharmaceutical production
Strong knowledge of cGMP and other regulatory requirements related to manufacturing biologics
Ability to think strategically and realize support vision in line with overall manufacturing mission and vision
Capable of making technically sound and compliant recommendations regarding cGMP operations
Organizational effectiveness and employee development focus
Actively seeks ways to improve current systems and processes related to manufacturing and individual activities
Proactively and systematically seeks and applies best practices for gap identification
Understanding of company business, objectives, and operations and how own activities fit within company strategy
MS Office, LIMS, SAP, TrackWise, EDMS, compliance, and strong scientific understanding
Location USA - MA - Lexington - BIO OPS
Compensation U.S. Base Salary Range: $174,500.00 - $274,230.00
Benefits U.S. based employees may be eligible for short‑term and/or long‑term incentives. 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.
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.
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.
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