The Senior Director, Process Design is accountable for global network of cell therapy Drug product (DP)process development. You will inspire creativity and implement end-to-end practices for leading cell therapy drug product processes and integrating with the global Cell Therapy(CT) operations network strategy. Accountable for holistic cell therapy DP process development strategy to ensure enterprise level considerations are applied across the portfolio of CT assets including all autologous based approaches (CAR and TCR-T), influencing overall CT development strategy. You will report to the Vice President, Process Sciences Analytics and Technology (PSAT) and work from either Santa Monica, CA or Gaithersburg, MD location.

 Role & Responsibilities

Lead all cell therapy DP process development activities and teams across multiple sites

Develop and implement cost-effective processes for autologous cell therapy approaches

Develop phase appropriate first in human processes to ensure speed on portfolio delivery

Develop global strategy and implementation of DP process strategy aligned with the internal operations network and commercial considerations for CT

Provide technical oversight of CT process related investigations at internal and external manufacturing sites in collaboration with MSAT Team.

Lead enterprise assessment of novel technologies including automation

Build teams. Develop world class scientific, technical and engineering talents and create an environment where they can excel.

Create partnerships to evaluate and evolve the department’s strategy to ensure agreement on our goals while balancing cost, time and speed.

Be a member of the Process Sciences, Analytics and Technology leadership team, participating in CMC program review and governance meetings and providing guidance for best practices and direction for continuous improvement.

Review regulatory CMC submissions to ensure their quality and technical content.

Required Abilities

Knowledge across multiple manufacturing technologies used for cell and gene therapy including viral and non-viral genome engineering technologies.

Experience with both autologous and allogeneic cell therapy manufacturing workflows is desirable.

Excellent data analysis experience with a variety of scientific software applications.

Proficient in experimental design with the ability to document laboratory procedures and experiments.

Demonstrated leadership and people management capabilities in driving change in; can guide appropriate dialogue at the senior level to escalate and resolve issues.

Builder and team leader – sought out by others as a coach.

Summarize scientific results in a concise manner to both technical and non-technical audiences.

Willing to accept responsibilities outside of initial job description.

Distill complex information in a concise, logical, and audience appropriate manner.

Education and Experience

A minimum of 14 years with BS/BA; 12 years with MS/MA or ten (10) years Phd in biochemistry, biochemical engineering, or related field.

A minimum 10 years of experience, leading teams of people (leading leaders) across multiple geographic locations (approximately 25 % travel required)

Demonstrated experience developing and establishing process strategies required for early, late, cell therapy processes

Experience with integration of process control strategies with understanding of attribute sciences

Experience with metabolomics and CT characteristics as it relates to production technology

Experience with analytical techniques used to characterize and measure CT approaches

Experience partnering with CMC teams to define and deliver tech strategy required for product development.

Experience partnering externally on product development

Understanding of enterprise network strategy and development execution impact on P&L

 

The annual base salary for this position ranges from $ 210,000 to $316,000 . However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

Our Benefits:

Benefits offered include:

A qualified retirement program [401(k) plan]

Paid vacation, holidays, and paid leaves

Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

#celltherapy #LI-Onsite

Date Posted

31-Jan-2025

Closing Date

20-Feb-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.