MS&T Material Manager

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 ~~~ .

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: ~~~.

The Role:

The Material Manager will be responsible for managing materials used in gene therapy manufacturing including single-use consumables, raw materials, and packaging materials. The position will own the Single-Use Program, maintain material qualification procedures, and will serve as a key stakeholder in the Material Review Board. The role is also responsible for effective collaboration with several stakeholders including but not limited to: Manufacturing, MSAT, Process Engineering, Process Development, Quality Assurance, Process Sciences, Regulatory, CMC teams, Facilities, Validation, Supply Chain, Quality Control, and various vendors.

Responsibilities:

• Responsible for ensuring all materials used in vial-to-vial manufacturing are appropriately qualified and adhere to single-use policies and procedures; ensures stable supply of materials at the phase appropriate level of quality and grade

• Drive risk assessments as required for materials, suppliers, and manufacturing locations

• Collaborate with supply chain department to create and manage Bill of Materials for processes executed in the Sanford manufacturing facility

• Author, revise, and review SOPs, qualification/validation protocols, reports, and material specifications

• Lead in managing and monitoring of testing activity with various Approved Contract Testing Laboratories

• Ensures sampling, inspection, testing, and release timelines are met; follows well-defined and established procedures and best practices

• Author and approve raw materials sections of multiple Biologic License Application (BLA) and Investigational New Drug (IND) applications

• Define roles, responsibilities, and actions for the Material Review Board meetings

• Support audits and inspections from internal and health authority organizations; support regulatory interactions and submissions

• Own and support material change controls, deviation investigations, root cause analysis, and CAPAs

• Ensure safety of single use components materials for chemical compatibility, sorption, leachable/ extractables, TSE/BSE, biocompatibility and bioburdensterility where needed

• Ensure the safety of raw materials for Melamine, Nitrosamine, BSE/TSE for all materials and bioburden, and endotoxin per intended use

Quantitative Dimensions:

The Material Manager will provide expertise in managing all aspects related to materials used in gene therapy manufacturing, from vial thaw to drug product vial filling, product and non-product contact. The role is expected to manage and lead material discussions, meetings, questions, and troubleshooting efforts. They are responsible for staying up to date on technology advances and recommend new technologies that will enhance processes.

Organizational Context:

The Material Manager will report to the Associate Director, MSAT & Engineering. 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.

Required Qualifications:

• MS in Engineering or Life Sciences with 3 years of relevant experience or BS with 5 years of relevant experience

• Experience in biologics GMP manufacturing

• Technical knowledge and experience in relevant areas of 21CFR, ICH, multi-compendial (USP, NF, EP, BP, JP) criteria, and FDA guidance documents as well as cGXPs in support of clinical and commercial manufacturing

• Proven knowledge in cGMP raw material and single-use consumable programs and material lifecycle management

• Experience with assessing single-use materials for chemical compatibility, sorption, leachables, extractables, biocompatibility, TSE/BSE control, and control of particulates, bioburden, and endotoxin

• Must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peers

• Ability to work in a fast-paced team environment with fluctuating priorities and collaborate effectively with others

• Excellent organizational and time management skills with ability to set own priorities and strong attention to detail

• High degree of flexibility, adaptability, and independence; able to work as needed to meet tight deadlines

• Ability to think critically and demonstrated troubleshooting and problem-solving skills.

• Experience working in cross-functional organization with ability to multitask, prioritize and be an effective and influential decision maker

• Demonstrate data integrity standards to ensure data of highest quality

• Mentor/train junior staff, may manage contractors

• Keep current with advances in technologies, evaluate and recommend new technologies that will be useful in expanding and enhancing platform processes; coordinate and champion deployment in manufacturing as appropriate and develop and execute engineering studies

• As assigned, this position may be required to work during non-traditional work hours to support critical business operations

Preferred Qualifications:

• Experience in gene therapy GMP manufacturing

• Experience in a start-up environment and pre-clinical through commercial GMP Manufacturing

• Understanding of industry expectations with respect to phase appropriate requirements while advancing products from clinical to commercial state

• Working knowledge of supply chain management, ERP and MES systems, and inventory management

Working Conditions:

• This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs

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

• On occasion, this role may travel to other Astellas Gene 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

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

Category Sanford TC

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

EOE including Disability/Protected Veterans