Senior Manager, Process Engineering at Astellas in South San Francisco, California

Job Description:

Are you ready to use your experience and expertise to make an impact on patient's 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)

The Role

We are seeking a highly motivated Senior Manager, Process Engineering, reporting to the Associate Director, MSAT & Engineering, who is responsible for the direction and oversight of the Process Engineering discipline within the MSAT & Engineering team at South San Francisco site. The incumbent provides engineering leadership to the South San Francisco team and to the broader Technical Operations organization across the Astellas Gene Therapies manufacturing network. Will evaluate/assign resources for the key functions and responsibilities of the Process Engineering function in South San Francisco and will provide guidance and support for the process engineering functions at other AGT locations (e.g. Sanford, NC).

Primary Responsibilities

* Provide expertise in process engineering, design, and ongoing operations for Process Development and GMP Manufacturing
* Provide oversight for onsite engineering and other engineering programs and initiatives
* Supports tech transfer for new processes and operations moving into the South San Francisco site operation
* Support and/or own equipment commissioning, training, and other lifecycle activities
* Develop and provide guidance and direction to engineering staff: define roles, set expectations, provide career development, and hold annual performance reviews
* Monitor process outcomes and in-process data to enhance process understanding and improvements
* Collaborate with management in Manufacturing, Process Development, Facilities, Supply Chain, QC, QA, and other Research & TechOps groups to resource and execute key organizational projects and initiatives
* Fosters and maintains a positive culture built around compliance and empowerment, that keeps the needs and safety of the patient at its core
* Assists in technical review and authorship of QE responses for Manufacturing
* Owns and maintains all process engineering-related documentation to support the Sanford site
* Represents the Process Engineering function as part of internal and external audits
* Supports process qualification and validation activities
* Supports regulatory and CMC activities to bring pipeline programs toward commercial states

About you

Must Have/Required

* BS in Chemical/Mechanical/Biological Engineering or Life Sciences with 8+ years of experience in engineering/scientific roles within a life sciences/biotech organization (with a significant portion of time focused on process engineering and/or manufacturing specifically) and 2+ years of managing engineering/science professionals (fulltime employees and/or contractors/consultants)
* Thorough technical and scientific knowledge of equipment and systems used for upstream and downstream unit operations, for mammalian biologics manufacturing processes
* Demonstrated ability to learn and apply the principles of new engineering disciplines along with the ability to process and analyze data, interpret results, and make conclusions and recommendations
* Curious, self-reliant, a good problem solver, and results-oriented
* Exceptional people management skills with ability and enthusiasm to lead, motivate, inspire, develop, and encourage staffs; proven ability to adapt to and lead change
* Ability to work independently as well as collaboratively across functions to achieve goals
* Desire and demonstrated ability to be creative and intuitive
* Understanding of cGMP, FDA, ISO, EMA, and ICH requirements
* 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 Qualifications

* MS or PhD
* Preferred experience supporting commercial sites
* In depth knowledge in process qualification and its life cycle
* 4+ years of management or lead experience in process engineering role
* 10+ years bio/pharma experience in a similar role
* Experience with single-use equipment and systems
* Experience in equipment and facility design

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

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled