Rocket Pharma is seeking a Global Project Team Manager, AAV to support planning, budgeting, integrating, tracking and communicating cross-functional activities for the Company’s product development programs. This will include working with internal stakeholders, academic partners and the Company’s designated Contract Manufacturing Organizations (CMOs).
- Lead cross-functional teams, plan and execute a fully integrated CMC & program plans (Pre-Candidate Nomination to IND to Phase I/II/III) for development and commercialization of AAV gene therapy programs.
- Establish clear scope of work, lead the delivery of project milestones on time and within scope through utilization of project management standards.
- Co-ordinate and track status of cross-functional communication and integration activities.
- Establish project team framework for Core, Clinical and CMC teams and help define team charters, roles and responsibilities and key deliverables for each team.
- Manage vendors and successfully transfer viral vector production technology to ensure timely supply of Toxicology and clinical trial material to meet regulatory and commercial deadlines.
- Lead the planning and execution of tech transfers, risk management, qualification, validation, resource allocation, and training.
- Facilitate problem-solving, contingency planning, and decision-making.
- Build and maintain effective teams: motivate, recognize, coach & mentor team members.
Education/Experience and Skills Requirements:
- Minimum BS in Biological Sciences, Bioengineering, Chemistry or an associated discipline. Masters or PhD preferred.
- 5-6 years of AAV and/or LVV gene therapy experience.
- Track record of leading and advancing projects from Discovery into Clinic including extensive experience with IND and BLA filings.
- Experience in tech transfers, manufacturing, quality systems, CMO management, regulatory requirements, and commercial development.
- Project management experience and/or PMP certification.
- Experience managing CMO/CTO relationships and projects desired.
- Working knowledge of US and European regulatory requirements.
- Outstanding organizational skills.
- Excellent written and oral communication skills.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment.
Location: New York, NY / Cranbury, NJ
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.
About Rocket Pharma
Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs. www.rocketpharma.com.
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Rocket Pharma is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Rocket Pharma via-email, the Internet or directly to hiring managers at Rocket Pharma in any form without a valid written search agreement in place for that position will be deemed the sole property of Rocket Pharma, and no fee will be paid in the event the candidate is hired by Rocket Pharma as a result of the referral or through other means.
*Please note, only qualified applicants that meet the requirements for the position will be contacted. This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.
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