Senior Director, Analytical Development

Rocket Pharmaceuticals•Cranbury, NJ

1d•$220,000 - $293,000

About The Position

Create a future where DNA is no longer destiny. Join Rocket Pharma. Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits. 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.