Associate Director, CMC

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 Associate Director, CMC Lead is responsible for providing CMC leadership for products at various stages of development­. They will represent Technical Operations on the core teams developing Astellas Gene Therapies products. Additionally, this role will build, lead and develop a team of CMC leads. This role is a key leadership role and will engage with stakeholders across the organization. The Associate Director, CMC Lead will work collaboratively with the various functional areas within Technical Operations and other AGT stakeholders to ensure smooth and efficient operational implementation of functional/COE goals. This role is a key contributor within Technical Operations at Astellas Gene Therapies. The successful candidate has extensive experience with CMC development ideally with experience in gene or cell therapy, with a proven track record establishing appropriate CMC development plans and strategy.

This role will be located at our South San Francisco location.

Primary Responsibilities

• Serve as CMC Lead on one or more core teams focused on developing Astellas Gene Therapies products

• Build, develop, and manage team of CMC leads

• Partner with Product Quality Lead(s) to ensure phase appropriate CMC development of the programs.

• Partner with project managers to ensure the development of cross-functional CMC development plan that aligns with Core Team and Astellas Gene Therapies objectives

• Reports program information and supports development of program presentations to the Research and Technical Operations Leadership, heads of functions, and other key stakeholders including business partners in the broader Astellas organization

• Drives teams to create and evaluate alternatives and identify recommended solutions to program issues

• Develops leadership, strategic thinking, and business acumen while setting high standards that drive alignment, collaboration, accountability and goal achievement within project teams

• Facilitates decision-making, collaboration, and problem-solving with people at all levels of the organization to accomplish shared program goals

• Understands, communicates and drives Technical Operations team to meet the deliverables & goals and challenges appropriately

• Monitors risks in real time to ensure appropriate mitigation plans are put in place

• Facilitate decision-making, collaboration, and problem-solving with people at all levels of the organization to accomplish shared program goals

• Effectively lead multiple programs and responsibilities concurrently

• Consistently perform duties within established SOPs, and in accordance with GxP requirements

• Other duties as assigned

About you

Must Have/Required

• BS/BA in related field with 6+ years of leadership experience in the biotechnology or pharmaceutical industry, with 4+ years' experience on core drug development teams

• Prior experience working in multiple phases of drug development (pre-IND to commercialization)

• Track record of delivering in a fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful and efficient

• Excellent verbal and written communication and facilitation skills; history of communicating clearly and concisely; bringing issues to closure in cross-functional group settings

• Outstanding influencing skills up, down and across the organization including executive/senior management

• Demonstrated experience building and leading complex technical teams

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

• Clear and succinct verbal and written communication skills

• Strong analytical, problem solving and critical thinking skills

• Excellent organizational skills, with a demonstrated ability to work in an extremely fast-paced, small company 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

• Demonstrated leadership and critical thinking skills

• 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

May Have/Preferred

• Advanced degree

• Previous experience in core CMC functions (e.g. analytical development, process development, manufacturing)

• Prior background as a CMC lead at a biotech/pharma company focused on gene therapy or cell therapy

• Drug development experience in all phases of development (e.g. IND, BLA)

• Experience within related functions (e.g. Clinical Operations, Research, Regulatory)

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 Regulatory Affairs

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans