Director, Manufacturing Operations

**Director, 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 **Director, Manufacturing Operations** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.** **Purpose:** The Director of Manufacturing is responsible for drug substance and drug product manufacturing operations. Manufacturing will be responsible for leading the manufacturing team through clinical and commercial readiness activities including executing process performance qualification (PPQ) batches, as needed by the business. Upon successful completion of GMP-Readiness, the role will work with the Operations Site Head and their colleagues across the site to manufacture clinical and commercial products to the highest standards of cGMP manufacturing. Additionally, this role supports site leadership with annual goal setting and budgetary planning activities impacting the site. This role serves as a strategic member of the Site Leadership team and actively participates in contributing input related to tactical and strategic decisions effecting the site and resource allocation needs. In collaboration with site functional leaders, coordinates and drives key strategic initiatives. **Essential Job Responsibilities:** + Recruit, hire, and develop a high-performing Manufacturing and MSAT & PE team; oversee the training and qualification of staff and develop, improve, and maintain documents such as batch records and SOPs to support manufacturing operations + Execute the production schedule to meet the material supply needs for the site; ensure operations and documentation is performed and reviewed as required to enable timely and compliant release of quality material that meets all release requirements. + Partner with Quality Assurance to complete investigations for nonconformances that arise during GMP manufacturing operations; identify and implement CAPAs to prevent recurrence; close quality records on time and support audits and inspections of the manufacturing areas; act as subject matter expert (SME) for manufacturing operations + Join forces with Quality Assurance, Validation, and Quality Control to maintain the qualification status of the area and operations (e.g., process, equipment, facilities) + Identify, lead, and/or support improvement initiatives; initiate and/or own change control records to document implementation of improvements and enhancements and collaborate with functional areas to develop appropriate resource and prioritization plans and appropriately escalate changes in resource demand, risks, gaps, or challenges + Support site leadership with annual goal setting and budgetary planning activities + Demonstrate influential communications and to execute deliverables efficiently and within critical expected timelines and fosters and maintains a positive culture built around compliance and empowerment, that keeps the needs and safety of the patient at its core. **Quantitative Dimensions:** The position currently leads manufacturing readiness activities as the GMP facility is built out, which includes finalization of equipment selection and layout, SOP, and other documentation generation, as well as the recruitment and training of staff. After the startup of manufacturing operations, the Director, Manufacturing will be responsible for executing process performance qualification (PPQ) batches and leading the manufacturing team through commercial readiness activities. Upon successful completion of PPQ, the role will work with the Operations Site Head and their colleagues across the site to manufacture clinical and commercial products to the highest standards of cGMP manufacturing. **Organizational Context:** The Director, Manufacturing will typically report to the Executive Director, Manufacturing Operations Site Head. 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. This role drives significant internal and external programs with broad functions and leadership to include yet not limited to: Operational Readiness; MSAT, Process Engineering; Validation; QC; Supply Chain & Materials Management; Facilities & Engineering; Quality Assurance, Engineering & Capital Projects; and associated counterparts in each functional area. **Qualifications:** **Required:** + Bachelor's Degree Required. + Business, sciences, or engineering along with previous experience overseeing site operational readiness activities in a new cGMP facility. + 10+ years of biopharmaceutical industry experience with 5+ years of management experience + Demonstrated leadership, critical thinking skills, and the ability to influence and drive milestones + Proven ability to work independently, prioritize and manage multiple tasks simultaneously and successfully in a matrix environment + Demonstrate clear and succinct verbal and written communication skills and strong analytical, problem-solving, and critical thinking skills + Excellent organizational skills, with a demonstrated ability to work in an extremely fast-paced, startup environment with changing priorities while maintaining attention to detail + Working knowledge of appropriate relevant regulatory guidance (e.g., ICH, FDA, and EMA) + Strong written and verbal communication skills, with the ability to clearly articulate complex concepts and strategies + Demonstrated experience with process tech transfer responsibilities. + Prior background and knowledge in cell therapy, cell processing and cell culture. **Preferred:** + Advanced degree desirable + Strong understanding of both upstream and downstream manufacturing unit operations + Experience starting up new sites and manufacturing operations + Experience with pre-approval inspections (PAI) and site licensure + Experience with biologics and cell-based therapies, specifically ESCs and/or iPSCs **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 Massachussetts TC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans