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

The Director, Manufacturing will typically report to the Executive Director, Manufacturing Operations Site Head. 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. This role drives significant internal and external programs with broad functions and leadership to include yet not limited to: Director, Operational Readiness; Sr. Manager, MSAT & Process Engineering; Manager, Validation; Associate Director, QC; Manager Supply Chain & Materials Management; Manager Facilities & Engineering; Executive Director Quality Assurance, Associate Director Engineering & Capital Projects; and associated SSF counterparts in each functional area

Qualifications:

Required

Business, sciences, or engineering along with previous experience overseeing site operational readiness activities in a new cGMP facility

10+ years of biopharmaceutical industry experience with 5+ years of management experience

Demonstrated leadership, critical thinking skills, and the ability to influence and drive milestones

Proven ability to work independently, prioritize and manage multiple tasks simultaneously and successfully in a matrix environment

Demonstrate clear and succinct verbal and written communication skills and strong analytical, problem-solving, and critical thinking skills

Excellent organizational skills, with a demonstrated ability to work in an extremely fast-paced, startup environment with changing priorities while maintaining attention to detail

Working knowledge of appropriate relevant regulatory guidance (e.g., ICH, FDA, and EMA)

Strong written and verbal communication skills, with the ability to clearly articulate complex concepts and strategies

Prior background in CMC project management at a biotech/pharma company and experience with preparations and activities associated with site licensure a must along with demonstrated experience with process tech transfer responsibilities.

Preferred

Advanced degree desirable

Strong understanding of both upstream and downstream manufacturing unit operations

Experience starting up new sites and manufacturing operations

Experience with pre-approval inspections (PAI) and site licensure

Experience with biologics and gene-based therapies, specifically AAV

Working Conditions

This is an on-site role working in a cGMP regulated manufacturing facility.

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

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.

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

#LI-TR1

Category Sandford TC

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

EOE including Disability/Protected Veterans