Senior Director, Process Development & MS&T

Rocket Pharmaceuticals • Cranbury, NJ

2d

About The Position

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.

Benefits

• equity participation
• 401(k) matching
• excellent health benefits
• 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