Job Description:

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Manufacturing Manager – Central Operations in our Alewife, Massachusetts facility.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

RESPONSIBILITIES:

The responsibilities for the Manufacturing Manager – Central Operations will provide management oversight and administration of the Manufacturing Operations. The Manufacturing Manager is accountable for managing the activities of the staff, monitoring the maintenance of equipment and facilities in production, overseeing complete documentation of all required production activities and ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies, and safety practices. 

(40%) Processing 

• Establish operational directives 




• Oversee the manufacturing area schedule to ensure market and inventory demands are met 




• Monitor expenses and maintain departmental budget 




• Provide technical expertise to drive resolution of manufacturing exceptions 




• Identify and lead continuous improvement efforts 




• Provide support for project portfolio management (capital projects and technology transfers) 




• Support interdepartmental collaboration to provide continuity between manufacturing sites 




• Must be responsible and accountable for delivery of functional area objectives on time and within budget. 

  (25%) People 

• Conduct routine staff meetings to ensure communication and engagement 




• Ensure staff development plans are in place and routine development discussions are held. 




• Establish department goals in accordance with site objectives 




• Ensure Departmental Safety Training is performed and personnel attend Site Safety Meetings 




• Maintain and promote a safe working environment. 




• Maintain audit readiness 




• Staff positions 




• Ensure adequate Assist in the assembly and disassembly of process equipment 

(35%) Quality 

• Participate in facility and process inspections by domestic and international regulatory agencies 




• Ensure that all SOPs and batch records are maintained to reflect current manufacturing methods and are in conformance with product licenses 




• Assure that production equipment and facilities are maintained in proper working condition and in a validated mode by assuring use of Change Control procedures 




• Ensure timely submission and completion of all area quality documentation to meet established timelines 




• Ensure that all compliance commitments are completed on time and provide documented evidence to support closure of each item according to the established timeline 

EDUCATION AND EXPERIENCE REQUIREMENTS 

• Bachelor's degree in Biology, Chemistry or related field with a minimum of 6 years relevant experience or Master's degree in Biology, Chemistry or related field with a minimum of 4 years relevant experience




• 10+ years of industry experience with 3 – 5 years of biologics manufacturing management experience 




• 3 - 5 years of experience as an area Manager in a bio-processing manufacturing environment 

• Knowledge of cGMPs, other regulatory requirements and aseptic processing 

Key Skills, Abilities, and Competencies 

• Must be able to inspire and motivate a Manufacturing team through leadership and implementation of effective management tools 




• Must understand the needs of key collaborators and customers and interact effectively intra- and inter-departmentally to achieve alignment




• Must be self-motivated and driven to independently accomplish department goals and objectives 




• Must possess excellent team management and presentation skills 




• DNA Capabilities: Judgment and Decision-Making, Inspiring and Motivating Others, 




• Developing Organizational Capability, Accountability & Ownership 




• Strong communication and interpersonal skills are essential safety shoes

Complexity and Problem Solving 

• Incumbent is responsible for resolving issues and making recommendations to meet plant production plan in a compliant manner




• Decisions made support the manufacture of high-quality bio-pharmaceuticals to our patients




• Solicits input from other function areas as required to facilitate timely decisions




• Is the point of contact for technical guidance and issues related to process or equipment in role as system owner




• Directly involved in policy setting and execution to improve plant operations

Locations

USA - MA - Alewife - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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