Senior Director, Analytical Development - Gene Therapy

Rocket Pharmaceuticals, Inc.; New Jersey; Hybrid; USD 220,000 - 293,000; Full time

Benefits offered by this job

Bonuses (short-term incentives)

Medical Insurance

Dental & Vision Insurance

401(k) with company match

Generous vacation

Job summary

Rocket Pharmaceuticals, Inc. is seeking an experienced Senior Director, Analytical Development to lead the analytical development and release/characterization activities for gene therapy programs.

You will guide the downstream viral vector and drug product development and manage a team of scientists in a fast-paced environment. The role requires deep expertise in assay development, GMP/ICH guidelines, and strong communication skills to drive cross-functional collaboration and ensure quality

Qualifications

• PhD in biochemistry, analytical chemistry, or related field with 10+ years in assay development or related biotech fields; MS with 12+ years or BS with 15+ years preferred.
• Minimum 5 years of leadership experience.
• Proven experience developing assays to support cell and gene therapy programs in development and GMP environments.
• Experience with AAV or LV technologies and viral vector biophysical characterization is a plus.
• Strong background in PCR, ELISA, HPLC/UPLC, and cell-based potency assays.
• Experience qualifying, verifying/validating, and transferring analytical methods to QC labs.
• Solid GMP/ICH knowledge.
• Proficiency in Excel and JMP; DNA analysis software familiarity.
• Excellent scientific writing and presentation skills.

Responsibilities

• Strategically lead and oversee the development and optimization of viral vector downstream and drug product release and characterization methods for GMP transfer
• Analytically support drug substance and drug product process development, including characterization and QA designations
• Review and approve technical documents, SOPs, method transfer/qualification/validation reports, specs, and study reports
• Provide hands-on leadership and guidance to scientific staff
• Mentor and develop a growing team of scientists

Skills

Analytical development leadership

Assay development

GMP experience

AAV/LV experience

Molecular assays (PCR/ELISA/HPLC)

Cell/gene therapy familiarity

Technical writing

Team leadership

Data analysis

Education

PhD in Biochemistry/Analytical Chemistry

Tools

Excel

JMP

DNA analysis software

Job description

Rocket Pharmaceuticals, Inc. is seeking an experienced Senior Director, Analytical Development to lead the analytical development and release/characterization activities for gene therapy programs.

You will guide the downstream viral vector and drug product development and manage a team of scientists in a fast-paced environment. The role requires deep expertise in assay development, GMP/ICH guidelines, and strong communication skills to drive cross-functional collaboration and ensure quality