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MS&T Material Manager - Sanford, United States - Astellas Pharma
Description
Job DescriptionDo 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.
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 Astellas Gene TherapiesAstellas 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:
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 gradeDrive risk assessments as required for materials, suppliers, and manufacturing locationsCollaborate with supply chain department to create and manage Bill of Materials for processes executed in the Sanford manufacturing facilityAuthor, revise, and review SOPs, qualification/validation protocols, reports, and material specificationsLead in managing and monitoring of testing activity with various Approved Contract Testing LaboratoriesEnsures sampling, inspection, testing, and release timelines are met; follows well-defined and established procedures and best practicesAuthor and approve raw materials sections of multiple Biologic License Application (BLA) and Investigational New Drug (IND) applicationsDefine roles, responsibilities, and actions for the Material Review Board meetingsSupport audits and inspections from internal and health authority organizations; support regulatory interactions and submissionsOwn and support material change controls, deviation investigations, root cause analysis, and CAPAsEnsure safety of single use components materials for chemical compatibility, sorption, leachable/ extractables, TSE/BSE, biocompatibility and bioburden/sterility where neededEnsure 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.
RequirementsRequired Qualifications:
MS in Engineering or Life Sciences with 3 years of relevant experience or BS with 5 years of relevant experienceExperience in biologics GMP manufacturingTechnical 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 manufacturingProven knowledge in cGMP raw material and single-use consumable programs and material lifecycle managementExperience with assessing single-use materials for chemical compatibility, sorption, leachables, extractables, biocompatibility, TSE/BSE control, and control of particulates, bioburden, and endotoxinMust be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peersAbility to work in a fast-paced team environment with fluctuating priorities and collaborate effectively with othersExcellent organizational and time management skills with ability to set own priorities and strong attention to detailHigh degree of flexibility, adaptability, and independence; able to work as needed to meet tight deadlinesAbility to think critically and demonstrated troubleshooting and problem-solving skills.
Preferred Qualifications:
Experience in gene therapy GMP manufacturingExperience in a start-up environment and pre-clinical through commercial GMP ManufacturingUnderstanding of industry expectations with respect to phase appropriate requirements while advancing products from clinical to commercial stateWorking 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 20lbsThis is an on-site role working in a cGMP regulated manufacturing facilityOn occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%)
Benefits:
Medical, Dental and Vision InsuranceGenerous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks401(k) match and annual company contributionCompany paid life insuranceAnnual Corporate Bonus and Quarterly Sales Incentive for eligible positionsLong Term Incentive Plan for eligible positionsReferral bonus programAll 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.
