2nd Shift Supervisor, Manufacturing
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
Astellas Institute for Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a 2nd Shift Supervisor, Manufacturing opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.
The Supervisor Manufacturing will be a key contributor to manufacturing readiness and future operational output for a Cell Therapy Manufacturing site. The role will initially support commissioning and start-up activities as the GMP facility is built. This includes equipment testing, layout planning, SOP and other documentation generation, as well as the recruitment and training of staff. The role will be responsible for executing a combination of engineering, clinical, and process qualification (PPQ) campaigns for multiple products with supporting staff. This role, as part of the Manufacturing leadership team, will be an integral contributor tasked with building a diverse and technically strong team for future successful GMP operations.
Essential Job Responsibilities:
Ensure seamless transfer of information and responsibilities across shifts and between processing areas.
Hire, train, supervise, and develop subordinate Manufacturing Associates while ensuring all parties are compliant with required GMP training and related documentation.
Support drafting, approval, and post execution review of manufacturing generated documentation, including SOPs and batch records while ensuring compliance and safety is always maintained on the manufacturing floor.
Coordinate with other departments to schedule work, order consumables, and implement projects that impact manufacturing milestones and/or process schedules.
Support and/or own quality investigations, CAPAs, and other compliance issues, ensuring that process improvement ideas and/or CAPA’s are both well designed and implemented in a timely manner.
Support regulatory inspection activities for manufacturing areas, personnel, and procedures.
Review all executed batch records and other documentation generated from the Manufacturing floor and ensure compliance with all approved procedures and cGMP requirements.
Build effective working relationships with cross-functional disciplines, ensuring company goals, process investigations, and improvement initiatives are carried out in an effective and collaborative manner.
Participate within process tech transfer forums by communicating operational capabilities and campaign performance data as well as contributing towards facility modifications when required.
Write, revise and review manufacturing documentation (MBRs, SOPs, Protocols, Change controls, deviations, etc.)
Organize continuous improvement ideas proposed by staff with a focus towards prioritizing projects with greatest benefit to safety, product quality, cost, and/or product throughput.
- The Supervisor Manufacturing is a key contributor to the readiness and future operational output of manufacturing. The person is responsible for the hiring, recruitment, training of staff and building a diverse and technically strong team. The role will be accountable for executing a combination of engineering, clinical, and process qualification (PPQ) batches.
The Supervisor, Manufacturing, will typically report to the Manager, Sr Manager, or Associate Director, Manufacturing. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.
BS / BA in Chemical/ Biological Engineering or Life Sciences with 5+ year of applicable industry experience or Associates Degree in Science with 7+ years of industry experience or H.S. diploma with 8+ years of industry experience
3+ years of experience leading teams in a GMP manufacturing environment
Technical understanding of a biotech manufacturing facility, with detailed knowledge of upstream and/or downstream operations
Proven effective problem-solving skills with an ability react quickly to process challenges
Strong safety focus with a proven ability to promote safety awareness within manufacturing organization
Will support and demonstrate quality standards to ensure data of highest quality.
Outstanding communicator with ability to work independently when required as well as closely within a team that may include external disciplines and key stakeholders.
Will be expected to perform other duties and/or special projects, as assigned.
Experience with disposable processing equipment
Cell Therapy manufacturing
Excellent aseptic technique
Production planning and execution.
This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, regular reaching over head activities, and independent mobility to lift to 25lbs.
This role is mainly operating in the cleanroom. Gowning into the cleanroom is expected.
This is a 100% on-site role working in a cGMP regulated manufacturing facility.
This role requires to work in shifts – 4 x 10s, 12 hrs. rotating, administrative or 2nd, depending on the business needs. Shift shall be assigned upon recruitment.
Assigned shift is subject to change based on business needs.
Weekend work is expected based on the staffing and operational needs.
On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%)
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Massachusetts TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans