Senior Director Process Development

A bit about us :

We are a clinical stage biopharmaceutical company dedicated to helping patients with unmet needs in the gene therapy space.

We are looking for a Senior Director of Process development to join the team. Please reach out to learn more!

Why join us?

Opportunity for growth in the clinical space and working on the strategy across all programs

Competitive compensation and benefits-401k match at 5%!

Experienced team with a focus on a collaborative culture

Helping patients with rare diseases live a better life

Job Details

Job Details :

We are seeking a full time Senior Director of Process Development to join our fast-paced and collaborative team. This role involves leading a team of scientists to develop candidates from early development through approval.

The successful candidate will have a deep understanding of process development, cGMP manufacturing and regulatory filings, and will be responsible for ensuring that all processes meet industry standards and regulations.

This role is pivotal to the continued success and growth of our company, making it an exciting opportunity for anyone looking to make a significant impact in the biotech industry.

Responsibilities :

1. Serve as an expert in the development of robust, high-performing processes for a specific therapeutic application with emphasis on compliance and support for regulatory submissions

2. Lead a team to develop rAAV candidates from early stages through regulatory approval

3. Develop scalable processes for clinical gene therapy vectors

4. Execute innovative process development projects through literature review and scientific collaboration

5. Provide strategic guidance for departmental and site operations

6. Act as the key point of contact for process development, technology transfer, and validation activities

7. Facilitate technology transfer for gene therapy candidates to contract manufacturing partners

8. Serve as the primary interface for CMC activities related to preclinical assets

9. Lead CMC activities for regulatory filings and interactions

10. Direct the design, scale-up, and technology transfer of manufacturing processes

11 Optimize processes and develop manufacturing platforms across multiple products

12. Oversee process characterization and validation strategies

13. Provide oversight for batch record review, deviation assessment, and batch release

14. Prepare development reports, transfer documents, and regulatory submissions

15. Manage CDMO development operations

16. Contribute to project proposals, timelines, and work plans

17. Prepare manuscripts and present findings at scientific conferences

Qualifications :

1. Advanced degrees (PhD) in chemical engineering, biochemical engineering or another scientific related discipline

2. A minimum of 10 years of experience in process development in the Life Sciences space, with a strong focus on gene therapy, leadership, cGMP manufacturing, regulatory filings, and more

3. AAV Gene Therapy experience is required

4. Late phase experience is ideal

6. Strong technical skills, with a deep understanding of the principles and techniques involved in process development.

7. Excellent problem-solving skills, with the ability to think strategically and make sound decisions.

8. Strong communication skills, with the ability to effectively convey complex technical information to a variety of audiences, and strong technical and scientific writing skills

9. A commitment to continuous learning and improvement, with a passion for staying up-to-date with the latest scientific and technological advancements.

This is a fantastic opportunity to join a dynamic team and play a key role in shaping the future of our company. Apply today to be considered for this exciting role.