Supervisor, Biopharma Manufacturing Operations

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 Team Lead, Biopharma Manufacturing Operations MA-TC opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Supervisor Manufacturing will be a key contributor to manufacturing readiness and future operational output. 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. After the startup of manufacturing operations are complete, the role will be responsible for executing a combination of engineering, clinical, and process qualification (PPQ) batches 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 and/or approval of manufacturing documentation, including SOPs and batch records.

• Coordinate with other departments to schedule work and other activities that impact manufacturing site milestones and/or process schedules.

• Coordinate with Supply Chain and the Warehouse to ensure materials and other consumables are ordered and received in time for both commissioning and production needs.

• Support and/or own quality investigations, CAPAs, and other compliance issues, ensuring that process improvement ideas and/or CAPA’s are implemented in a timely manner.

• Support regulatory inspection activities for manufacturing areas, personnel, and procedures.

• Attend safety meetings, ensure that staff adheres to all safety procedures as defined, and maintain a safe work environment within manufacturing owned areas.

• 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.

Quantitative Dimensions:

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.

Organizational Context:

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 and Cell Therapies and the Astellas organization.

Qualifications Required:

• BS / BA in Chemical/ Biological Engineering or Life Sciences with 4+ years of applicable industry experience or Associate degree in science with 6+ years of industry experience or H.S. diploma with 8+ years of industry experience.

• 1-2 years of experience leading teams, including peers, in a GMP manufacturing environment.

• Technical understanding of a biotech manufacturing facility, with detailed knowledge of upstream and/or downstream operations.

• SME on Aseptic Technique.

• Strong understanding on cell culture.

• 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.

Preferred:

• Experience with disposable processing equipment.

• Experience starting/scaling up a new manufacturing facility.

Working Conditions:

• 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 is an on-site role working in a cGMP regulated manufacturing facility.

• On occasion, this role may travel to other Astellas Gene and Cell Therapies manufacturing facilities (0-5%).

Benefits:

• 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

#LI-TD

Category Massachusetts TC

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans