Senior Director, Process Development & MS&T

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. The CMC group at Rocket Pharma is seeking an experienced Sr. Director of Process Development (PD) and Manufacturing Science and Technology (MS&T) to join our Technical Development team. The ideal candidate will have extensive experience and knowledge in process development and manufacturing technical support with a passion for tackling new challenges in a fast-paced, dynamic environment. This role will involve overseeing new and existing platform process development activities to support early- and late-stage 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 chemical engineering, biochemical engineering, bioprocessing, bioengineering, biochemistry, biological sciences, or relevant field of study with 10 years of experience in a biotech/biopharmaceutical industrial setting, M.S. with 12 years of relevant experience, or an equivalent combination of education and experience or BS with 15 years of leadership experience.
Viral vector process development experience required, hands-on experience with AAV processing preferred
Proven success in developing/optimizing processes while leading end-to-end PD/MS&T functional areas
Direct experience with process tech transfer, viral clearance, comparability, control strategies, process characterization and process validations/PPQ
Excellent communication and presentation skills, capable of conveying complex technical information in a clear, thorough, and influential manner is required.
Experience with statistical analysis tools (e.g., JMP, Minitab) is required.
Eager to work with highly skilled and dynamic teams in a fast-paced, entrepreneurial, and technical environment.
Motivated to drive functional initiatives to evaluate novel technologies and develop templates, platform, and technical standards to support organization growth.
Excellent MS Office skills with a specific focus on word, excel and power point applications to author technical reports and presentations.

Nice To Haves

hands-on experience with AAV processing preferred

Responsibilities

Serve as Head of Process Development (Upstream, Downstream) and Manufacturing Science and Technology to represent the functional area on cross-functional and cross-divisional teams working with Analytical, Manufacturing, Supply Chain, Quality and Regulatory functions.
Strategically position PD/MS&T to execute on both supporting current Manufacturing campaigns and establishing/optimizing new platforms
Lead scale-up and scale-down model establishment and qualification activities to enable process characterization and manufacturing investigations.
Author and review regulatory and process development documentation.
Provide hands-on leadership and guidance to scientific staff.
Foster the development, coaching, and mentoring of a growing team of scientists.