Thermo Fisher Scientific Manufacturing Manager, Drug Product in Plainville, Massachusetts
Thermo Fisher Scientific’s Viral Vector Services (VVS) is a rapidly growing, multifaceted gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven proficiencies and strong character to join our team and help lead our organization into the future.
Plainville, MA (5 Commerce Boulevard): In this role you will help support and execute the large capital facility project through the construction of a new state-of-the-art commercial manufacturing facility.
Shift: 12/hour rotating shift from 7AM – 7PM or 7PM-7AM
How will you make an impact?
As part of Thermo Fisher’s Viral Vector Services organization in Plainville, the Manager of Drug Product Manufacturing is responsible for leading the team responsible for the formulation, filling, and component preparation activities required for viral vector manufacturing. This position reports into the Head of Drug Product Manufacturing and will play a vital role in plant start-up activities as well as be responsible for building the drug product team to support commercial manufacturing operations. He/she provides the cross functional leadership, operations acumen, and results focus to reliably meet timelines and due dates. This position requires an individual capable of partnering across the site to ensure on-time solution deliveries including completed documentation, on-time investigations, CAPA implementations, delivering robust business processes to drive sustainable performance and support the release of product in a fast-paced production environment.
What will you do?
Lead team of manufacturing supervisors and technicians supporting the formulation, filling and component preparation required for viral vector drug product manufacturing.
Meets with technicians/operators regularly to discuss goals and development.
Proactively directs and delegates staff to ensure the execution of the daily manufacturing schedule.
Performs batch record review, procedure revisions, and work order generation.
Performs training with staff on the floor, as needed.
Reviews and approves Manufacturing related documentation.
Supports equipment, documentation, investigations and improvement initiatives within manufacturing operations.
Utilizes manufacturing processes knowledge and investigational skills to identify and resolve manufacturing issues and drives continuous improvement in process operations.
Maintain key performance indicators in alignment with department and product supply goals, maintain and report applicable area or organizational metrics.
Organize and lead ad hoc cross functional teams to manage investigations and implementation of changes.
Drive continuous improvement and operational excellence culture.
Program management and clients to implement product / process improvements; participates and/or may lead cross functional projects.
Acts as manufacturing subject matter expert for assessments for change controls, validation protocols, and document changes.
How will you get there?
High School / GED required with 5-8 years of related work experience.
Bachelor's Degree and 4-6 years of related work experience
Master’s degree and 2-4 years of work experience.
Minimum of 4 years in management / leadership positions. Preferred experience working in 2 or more functional areas.
Minimum of 3 years leading cGMP operations teams in fast paced production environment.
Understands aseptic processing, environmental controls and automated filling systems.
Understands inspection of filled vials, labeling and vial reconciliation requirements.
Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously.
Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
Strong planning, organization and multitasking skills.
Solid understanding of applicable regulatory requirements.
Demonstrated ability to manage cross-functional teams and collaborate across the business. Strong analytical and problem solving skills; great attention to detail and excellent decision making process.
Expertise in managing small and medium technical and/or capital projects.
Demonstrated ability to present ideas persuasively and negotiate effectively.
The ability to work effectively with a wide range of constituencies in a diverse community.
Proficient at public speaking, teaching, facilitating to peers, manufacturing staff, and area management within their operational group.
Recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc.) to manufacturing or area management.
Ability to function in a dynamic environment and balance multiple priorities simultaneously.
Ability to learn new software and tools quickly.
Ability to make decisions and work with minimal to moderate supervision.
Ability to aseptically gown and/or sterile gown as needed.
While performing the duties of this job, the employee:
Gown aseptically and/or sterile gown as needed.
Adhere to all Personal Protective Equipment (PPE) requirements used within cGMP manufacturing.
Is required to write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
Is regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods.
The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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