When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Location/Specific Division Information: Thermo Fisher Scientific Viral Vector Services (VVS), is a rapidly growing, dynamic gene therapy contract development and manufacturing organization. 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 competencies and strong character to join our team and help lead our organization into the future.
Address: 250 Binney Street Cambridge, MA
Day Shift Schedule: 12 Hour Rotating Shift (2/2/3 format) 7AM-7PM
How will you make an impact?
The Manufacturing Manager will lead cGMP manufacturing activities to ensure that Brammer Bio provides clients with materials for clinical and commercial use. The incumbent will develop and drive manufacturing operations including tech transfer and new production equipment. Additional activities include: review and approval of SOP’s and Work Instructions, deviations, CAPAs and production batch records. The Manager will also participate in and supervise personnel to coordinate manufacturing production activities including upstream, downstream, final fill and package and labeling of therapeutic products. Other responsibilities include working closely with related functional areas to achieve production goals and timelines, and to create performance and developmental plans for staff.
What will you do?
Provide leadership and oversite for phase III and commercial manufacturing operations.
Ensure cGMP procedures are reviewed and that staff is training on relevant curricula.
Participate in developing site metrics.
Facilitate technical transfer of client processes to manufacturing. Review and approve batch records, change controls and project plans.
Ensures the development and delivery of new skills necessary to support cGMP manufacturing on new processes and equipment.
Support and develop consistent manufacturing standards for controlled documents used within cGMP manufacturing.
Supports investigations and is involved with CAPA recommendations.
Delegate or lead the writing of deviations, planned variance, change control forms or CAPAs as required.
Supports cross-functional company goals.
Builds cross-functional relationships and enhances relationships with team members.
Works cooperatively with others to meet group and organizational goals.
Meet with Supervisors regularly to discuss goals, planning, and progress.
Continuously builds a high-performance diverse team of people to achieve objectives.
Develops self and others to improve performance in current role and to prepare for future roles.
Seeks and welcomes feedback and responds to coaching.
Provides frequent feedback and coaching to others on ways to improve performance.
Recognizes and celebrates successes.
Participates in initiatives to support, innovation and continuous improvement activities and improved compliance with quality procedures, policies and regulations.
Participate in client and planning meetings as requested.
How will you get here?
High School Diploma / GED required. Bachelor’s in Life Sciences, Engineering or Masters preferred.
Minimum of 8 years’ management experience in pharmaceuticals manufacturing.
Demonstrated ability to motivate exempt and non-exempt employees and demonstrated management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution). Thorough knowledge of cGMPs.
Strong interpersonal and communications skills; written and oral.
Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously.
Strong planning, organization and multitasking skills.
Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
Ability to make decisions and work with minimal to moderate supervision.
Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups.
Solid understanding of applicable regulatory requirements.
While performing the duties of this job, the employee is required to:
Gown aseptically and/or sterile gown as needed.
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.
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.
Must be willing to work 7am-7pm on rotating days.
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.