Massachusetts Jobs

Senior Manager, 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 Senior Manager, Manufacturing opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Sr. Manager, Manufacturing, will be a key contributor to manufacturing readiness and future operational output. In strict compliance with cGMP regulations, the Sr. Manager of Manufacturing is responsible for independently overseeing the production of cellular products ranging from MCB/WCB cell banking, toxicology lots, engineering, clinical, process qualification (PPQ) batches to commercialization. This individual will oversee implementation of cell manufacturing operations by working in a hands-on and collaborative fashion with other cross functional stakeholders to ensure that cellular product is produced on time and in a compliant manner. Candidate should be familiar with working in a cleanroom environment and have extensive knowledge of cell culture techniques. This position oversees technical investigations for process deviations, change controls and CAPAs to ensure production proceeds as scheduled. The candidate should be a highly motivated self-starter, invested in the development of the team and is comfortable working in a hands-on environment. In addition, this role will support as needed, commissioning and start-up activities as new areas of 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. As a part of the Manufacturing leadership team, this role will be an integral contributor tasked with building a diverse and technically strong team for future successful GMP operations. This role typically reports to the Associate Director or Director of Manufacturing.

Essential Job Responsibilities:

• Recruit, hire, and develop a high-performing manufacturing team; oversee training platforms and ensure applicable qualifications are completed as required for entire staff.

• Oversee the drafting, approval, and post execution review of manufacturing generated documentation, including SOPs and batch records while ensuring the highest level of compliance and personnel safety is maintained on the manufacturing floor.

• Partner with Quality Assurance to complete investigations for nonconformances that arise during GMP manufacturing operations; identify and implement effective CAPAs to prevent recurrence; close quality records on time.

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

• Identify, lead, and/or support improvement initiatives; initiate and/or own change control records to document implementation of improvements and enhancements.

• Build effective working relationships with both cross-site and cross-functional disciplines, ensuring company goals and process platforms are carried out in an effective and collaborative manner.

• Lead process tech transfer forums as a manufacturing operation representative through communication of operational capabilities and campaign performance data as well as contributing towards facility modifications when required.

• Provides oversite and guidance to the manufacturing staff and ensures all operations are performed according to standard operating procedures.

• Assist with the prioritization of projects with greatest benefit to safety, product quality, cost, and/or product throughput.

• 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.

• Leads the team and department in implementing and following best practices and meeting department goals.

Quantitative Dimensions:

The Sr Manager, Manufacturing, is a key contributor to the readiness and 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 batch executions, scheduling, and compliance.

Organizational Context:

The Manager, Manufacturing, will typically report to the Associate Director or 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. This role provides primary oversight for supervisor and specialist type internal/external roles.

Qualifications Required:

• BS / BA in Biological sciences or equivalent with 6+ year of applicable industry experience or Associate’s Degree in Science with 8+ years of industry experience or H.S. diploma with 10+ years direct industry experience or 12+ years indirect industry experience in a regulated manufacturing environment.

• 4+ years of experience leading teams in a GMP manufacturing environment.

• Expertise in aseptic processing and cell culture such as human Embryonic /Pluripotent Stem Cells or direct experience in cell culture manipulations related to cell product process development and/or manufacturing.

• Proven effective problem-solving skills with an ability react quickly to process challenges.

• Strong safety focus with a proven ability to promote safety conscious within manufacturing organization.

• Will support and demonstrate quality focus to ensure data and product output is maintained within the highest quality standards.

• 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

• Operational excellence

• Excellent aseptic technique

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