Manufacturing Specialist

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

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

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Our Values:

• Be BOLD (Find a Way)

• Care Deeply -- for our patients, each other and our work

• #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

As a member of the Astellas Gene Therapies (AGT) Manufacturing team, the Manufacturing Specialist is responsible for the support of operations execution of the Upstream, Downstream, and Filling manufacturing operations. The incumbent will work with cross functional teams including Quality Assurance, Process Engineering, Supply Chain, and Manufacturing. The Manufacturing Specialist will report to the Associate Director of Manufacturing and will be located in South San Francisco.

Primary Responsibilities

• Write, modify, and implement GMP Procedures and Batch Records

• Ensure manufacturing systems and practices are consistent throughout the organization.

• Respond operational issues and drive robust and compliant processes changes in accordance with AGT's policies and procedures, regulatory requirements, guidelines, and recommendations.

• Manage and own deviations in the Quality Management System as necessary to support the Manufacturing Teams

• Support and/or own impact assessments to support the Manufacturing teams.

• Investigate and identify true root cause of incidents and determine appropriate Corrective and Preventive Actions

• Initiate and manage Change Records

• Collaborate and contribute to comprehensive implementation plans for investigations and changes

• Use defined metric processes to recognize potential deviations and escalate to MFG Management and QA

• Develop and deliver GMP and/or Manufacturing-related training to Manufacturing floor staff

• Maintain and adjust the MFG schedule

• Assist with various audits and Facility walk throughs, responses and corrections

• Coordinate with Facility on equipment availability for PMs and Cals

• Coordinate with supply chain, warehouse, and procurement to ensure materials and other consumables are readily available for production needs

• Aid in troubleshooting and resolving technical issues using root cause analysis tools

• Coordinate with Manufacturing staff to drive continuous improvement initiatives

• Oracle SME, work definitions

• Drive process improvements and lean manufacturing principles.

About you

Must Have/Required

• BS in Chemical/ Biological Engineering or Life Sciences plus 5+ years of experience in life sciences in manufacturing operations roles.

• Familiarity with clinical and commercial pharmaceutical manufacturing operations including Drug Substance and Drug Product operations.

• Outstanding ability to comprehend technical information as it pertains to equipment and processes.

• Proven ability to identify problems and apply a disciplined methodology to identify data-driven root causes.

• Demonstrated history of working independently, with minimal supervision, and managing cross functional projects.

• Proactively adjusts their work to meet changing business needs.

• Demonstrated success and desire to work with in a fast-paced environment.

• Maintains energy and drive when faced with challenges.

• Strong attention to detail supported by excellent time management and organizational skills.

• Proficiency with MS Office (Excel, PowerPoint, Word, MS Project and MS Visio).

• 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

May Have/Preferred

• 8+ years' industry experience in Drug Substance and Drug Product.

• Knowledge or proficiency with single use equipment and systems.

• Knowledge of cGMP and good documentation practice (GDP).

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

• Understanding of regulatory requirements, guidelines, and recommendations.

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

• 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

Category Manufacturing

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

EOE including Disability/Protected Veterans