Senior Director, Analytical Development

Posted 2 Days Ago
Be an Early Applicant
Cranbury, NJ, USA
In-Office
220K-293K Annually
Senior level
Biotech
The Role
Leads analytical development for viral vector and drug product programs, including assay development, method optimization, characterization, GMP transfer, qualification, validation, and technical documentation. Provides analytical support for cell and gene therapy development, reviews quality documents, and leads, coaches, and mentors scientific teams. Requires extensive biotechnology experience, leadership expertise, and proficiency with molecular, immunoassay, chromatographic, and cell-based potency assays.
Summary Generated by Built In
Overview

Create a future where DNA is no longer destiny. Join Rocket Pharma.


Rocket Pharma is a fully integrated, commercial-stage biotechnology company advancing genetic medicines for rare and devastating diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking genetic medicine 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.

Position Summary

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.

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.
Qualifications
  • 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.
  • 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.
  • 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.
Compensation

The expected salary range for this position is $220,000 to $293,000. 


At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee’s experience, location of the position and availability of similar talent in a competitive market.


For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts.


In addition to base salary, Rocket offers a competitive total rewards package that may include 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, and a variety of wellness resources and employee support programs. Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives).

EEO Statement

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

Skills Required

  • PhD in biochemistry, analytical chemistry, or a related biological science discipline, plus 10 years of biotechnology or biopharmaceutical industry experience in assay development or related cell or gene therapy fields
  • Alternatively, an M.S. with 12 years of relevant experience or a B.S. with 15 years of relevant experience
  • At least 5 years of leadership experience
  • Experience developing assays for cell and gene therapy programs in development and GMP environments
  • Experience qualifying, verifying, validating, and transferring analytical methods to a QC laboratory
  • Extensive experience developing molecular PCR, ELISA, HPLC or UPLC, and cell-based potency assays
  • Strong understanding of GMP and ICH guidelines
  • Experience leading teams and developing team members
  • Proficiency in Excel, JMP, and DNA analysis software
  • Excellent technical writing, oral presentation, communication, time management, prioritization, accountability, and scientific rigor
  • Direct experience with AAV or LV technologies
  • Expertise in viral vector biophysical characterization, including particle distribution analysis, capsid characterization or modification, and viral genome sequencing
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The Company
202 Employees
Year Founded: 2015

What We Do

Rocket Pharmaceuticals is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. Its mission is to seek gene therapy cures through innovative science and platforms. The company describes a creative, compassionate, driven team and a collaborative environment where bold ideas thrive and every team member makes a meaningful impact for patients.

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