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Astellas Pharma Principal Process Engineer in South San Francisco, California

Why Work for Us

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 Right. 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 (AGT), an Astellas Company, is 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.audentestx.com

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:

The Principal Process Engineer will be a member of the site Manufacturing Science and Technology organization and will be responsible for process engineering and single use technology, with emphasis on downstream processes. The incumbent will provide technical engineering leadership to support installation, and qualification of new equipment and single use systems and troubleshoot existing equipment for various GMP and development processes; and assist in the technical transfer and implementation of conceptual processes at manufacturing scale. The role is also responsible for effective collaboration with Manufacturing, Process Development, Quality, Facilities, and various vendors. This position will be located in South San Francisco.

Responsibilities:

  • Lead engineering, design, and on-going improvements for facility startup and manufacturing activities

  • Lead tech transfer initiatives for new and existing platform technologies

  • Lead all aspects of capital equipment implementation from design through validation activities

  • Partner with Project Engineering to plan for future manufacturing capacity expansion and perform facility fit evaluations

  • Support Single-Use (SU) technology program development and deployment

  • Keep current with advances in technologies and engineering best practices that will be useful in expanding and enhancing platform processes; coordinate and champion deployment across the Astellas' manufacturing network

  • Lead or collaborate cross site engineering forums focused on promoting collaboration, process performance review, gap remediation, and continuous improvement initiatives

  • Interact closely with vendors for SU material and equipment procurement, as well as new technology implementation

  • Author and review CMC regulatory documentation and participate in program alignment meetings

  • Define, initiate, and execute project-related change control processes with input from cross functional team members

  • Author process descriptions, technical reports, and test plans in accordance with tech transfer enablement activities

  • Lead projects comprised of multiple interdisciplinary groups (Manufacturing, Quality Assurance, Quality Control, Process Development, Validation, Automation, Facilities, etc.)

  • Lead or collaborate process performance qualification activities

  • Act as SME during internal or external audit

  • May manage and mentor junior Process Engineers and/or engineering contractors

Required Qualifications

  • BS or MS in Chemical/Mechanical/Biological Engineering or Life Sciences with 12+ years of experience in life sciences, including 10+ years as a Process Engineer

  • Thorough knowledge of equipment and systems used for bioprocess operations

  • Demonstrated history of working independently, and managing multiple projects

  • Demonstrated ability to learn and apply the disciplines of new engineering disciplines

  • Experience leading or supporting commissioning and qualification-related activities such as FAT, SAT, and IQ/OQ

  • Experience with scale-up/scale-down and tech transfer

  • Self-reliant, a good problem solver, and results oriented

  • Demonstrated success and desire to work with a diverse team in a fast-paced environment under challenging timelines

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

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

  • Must be willing to work a flexible schedule and be on-call to support onsite MSAT teams, as needed. This could include, evenings, weekends and holidays, as needed

  • Models our Core Values: Be Bold, Care Deeply, #GetStuffDone -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

Preferred Qualifications:

  • 12+ years bio/pharma experience in an equivalent role

  • Experience leading or supporting facility startup engineering activities

  • Experience with single-use equipment and systems

  • Detailed knowledge of cGMPs and good documentation practices (GDP)

  • Experience with process equipment and facility design

  • Experience with process performance qualification life cycle

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 MSAT

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

EOE including Disability/Protected Veterans

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