"Alerted.org

The Specialist III BioPharma Manufacturing Technical Support will be part of the Manufacturing team. The Specialist role is responsible for the support of manufacturing operations typically assigned to either Upstream, Downstream, or Filling. The incumbent will work with cross functional teams including Quality Assurance, Process Engineering, Supply Chain, and Manufacturing. The Senior Manufacturing Specialist typically reports to the Manager, Sr Manager, or Associate Director of Manufacturing.

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** .

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: www.astellasgenetherapies.com.

The Role:

The Specialist III Biopharma Manufacturing Technical Support will be part of the Manufacturing team. The Specialist role is responsible for the support of manufacturing operations typically assigned to either Upstream, Downstream, or Filling. The incumbent will work with cross functional teams including Quality Assurance, Process Engineering, Supply Chain, and Manufacturing. The Senior Manufacturing Specialist typically reports to the Manager, Sr Manager, or Associate Director of Manufacturing.

Responsibilities:

+ Responsible for manufacturing reform / updates, including SOPs and batch records, ensuring all proposed updates are reviewed / approved prior to issuance.

+ Will develop and deliver GMP and/or Manufacturing-related training to Manufacturing floor staff and facilitate updates or improvements to on-the-job training platforms while ensuring training curriculum is updated to reflect current process configurations.

+ Will monitor process performance metrics, investigating operational issues, escalating potential nonconformances to management and QA as deemed appropriate.

+ Responsible for leading Manufacturing nonconformances in the Quality Management System, identifying true root cause of incidents and recommending appropriate corrective / preventive actions when required.

+ Responsible for change records, overseeing comprehensive implementation plans for investigations and/or continuous improvement changes, ensuring processes changes are in accordance with AGT’s policies and procedures, regulatory requirements, guidelines, and recommendations. As assigned, will serve as project lead, or participate as a Technical SME on other site specific and/or cross-site programs.

+ Will work with outside vendors and internal departments (maintenance, engineering, quality, etc.) to troubleshoot equipment performance issues.

+ Assists with various audits and Facility walk throughs, responses, and corrections.

+ Coordinates with other departments to schedule work and other activities that impact manufacturing site milestones.

+ Will design new or modify process MTL’s, contribute to the population / maintenance of process descriptions, and maintain product specific sample plans for incoming clinical tech transfer programs.

+ Oracle SME, responsible for the population and maintenance product specific work definitions.

Quantitative Dimensions:

The Specialist III BioPharma Manufacturing Technical Support will ensure the delivery of GLP and GMP material by ensuring manufacturing systems and practices are consistent, follow AGT policies and procedures, regulatory requirements, guidelines, and recommendations. They will implement GMP procedures and Batch Records, seek out, initiate, and lead process improvements, and under direction of management, will provide all training and resources to the Manufacturing staff. This role serves as the Mfg. Technical Subject Matter Expect (SME) for Mfg. Operations.

Organizational Context:

The Specialist III BioPharma Manufacturing Technical Support, will report to Team Lead BioPharma Manufacturing Operations or Lead BioPharma Manufacturing Operations. 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.

Qualifications

Required:

+ BS / BA in Chemical/ Biological Engineering or Life Sciences plus 5+ years of experience in life sciences in manufacturing operations roles or Associates Degree in Science or related field with 7+ or H.S. diploma with 10+ direct related industry experience.

+ Familiarity with clinical and commercial pharmaceutical manufacturing operations including Drug Substance and Drug Product operations and demonstrated experience and ability to comprehend technical information as it pertains to equipment and processes and proven ability to identify problems and apply a disciplined methodology to identify data-driven root causes.

+ Prior work history requiring working independently, with minimal supervision, and working with and/or leading cross functional projects; along with proven ability to proactively adjust their work to meet changing business needs.

+ Demonstrated success and desire to work with in a fast-paced environment and influential skills with coworkers and cross-functional key stakeholders.

+ Strong attention to detail supported by excellent time management and organizational skills. proficiency with MS Office (Excel, PowerPoint, Word, MS Project and MS Visio), and proven ability to work in faced paced changing environment.

+ Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.

Preferred:

+ 2+ years experience in the manufacture of sterile injectable products in a regulated environment.

+ 1+ years experience of technical writing (nonconformances, SOPs, batch records, change controls, CAPAs, etc.).

+ Experience with the following equipment: Filter integrity testers, autoclaves, Drug Product fillers and isolators, single use systems and aseptic connections

+ Hands-on experience with PUPSIT.

+ Completion of the BioWork Certification Program or related industry type programs are considered a plus.

+ Industry experience in Drug Substance and Drug Product and knowledge or proficiency with single use equipment and systems and cGMP and good documentation practice (GDP).

+ Experience with Quality Systems, RCAs, and investigational ownership.

Working Conditions:

+ On occasion, this role may travel to other Astellas Gene Therapies or Astellas manufacturing facilities (0-5%)

+ 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.

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._

\#LI-TR1

Category Sanford TC

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

EOE including Disability/Protected Veterans