Senior Director, Analytical Development

Rocket Pharmaceuticals • Cranbury, NJ

1d

About The Position

Rocket Pharma is seeking an experienced Senior Director, Analytical Development to join our Technical Development team. Reporting to the Vice President, Technical Development, the ideal candidate will have extensive experience and knowledge in assay development and a passion for tackling new challenges in a fast-paced, dynamic environment. This role will involve coordinating internal testing and development activities to support pipeline products, as well as providing leadership to a team of scientists. We are looking for someone who is deeply curious about science and gene therapy and is motivated to translate innovative research into impactful therapies.

Requirements

• PhD in biochemistry, analytical chemistry, or a related biological science discipline, with 10 years’ experience in the biotechnology/biopharmaceutical industry in assay development or related fields in cell or gene therapy; M.S. with 12 years of relevant experience, or BS with 15 years of experience
• Minimum 5 years leadership experience required
• Proven experience developing assays to support cell and gene therapy programs in both development and GMP environments.
• Extensive background in developing molecular (PCR), ELISA, HPLC/UPLC and cell-based potency assays
• Significant experience qualifying, verifying/validating, and transferring analytical methods to a QC lab setting.
• Strong understanding of GMP and ICH guidelines.
• Proficient in Excel, JMP, and DNA analysis software.
• Ability to thrive in a fast-paced environment, meet deadlines, and prioritize multiple projects.
• Experience in leading teams and fostering the development of team members.
• Excellent communication skills in technical writing and oral presentation.
• A strong sense of responsibility, scientific rigor, accountability, and integrity.
• Strong time management skills with the ability to prioritize tasks across multiple projects to meet deadlines.

Nice To Haves

• Candidates with direct experience in AAV or LV technologies, and/or expertise in viral vector biophysical characterization (e.g., particle distribution analysis, capsid characterization/modification, and viral genome sequencing), will be given strong consideration.

Responsibilities

• Strategically lead and oversee the development and optimization of viral vector downstream and drug product release and characterization methods in preparation for transfer into a GMP environment
• Analytically support drug substance process development and drug product development efforts, including characterization of processes and finished products, as well as establishing/refining Quality Attribute designations
• Review and approve technical documents, standard operating procedures, method transfer/qualification/validation reports, specifications, and relevant study reports.
• Provide hands-on leadership and guidance to scientific staff.
• Foster the development, coaching, and mentoring of a growing team of scientists.

Benefits

• equity participation
• 401(k) matching
• excellent health benefits
• bonuses (short-term incentives)
• medical, dental, and vision insurance
• life insurance
• 401(k) with company match and generous vesting
• paid vacation and holidays
• global shutdown days between Christmas and New Year’s
• a variety of wellness resources and employee support programs
• equity awards (long-term incentives)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree