Location: Cranbury, NJ
Travel Requirements: Up to 20%
Relocation Available: Yes
Rocket Pharma is a company bringing hope and relief to patients with undertreated rare diseases through the development and commercialization of curative first-in-class gene therapies. We are seeking a motivated candidate who will primarily be responsible for oversight and management of internal and external stakeholders enabling GMP manufacturing activities for ex vivo lentivirus drug product. The ideal applicant will have a strong background in cell and gene therapy and the associated analytics for in process characterization and drug product testing. The position will also support platform-focused drug substance/product projects requiring technology development and platform optimization. The incumbent will collaborate with cross-functional department colleagues working within Rocket Pharma and other partners to ensure the successful execution of Rocket Pharma’s company business strategies and company objectives.
- Extensive interaction and monitoring contract manufacturing organizations (CMOs) and contract testing organizations (CTOs) for the manufacturing and timely release of ex vivo lentivirus drug product
- Review of executed batch records and other production related documents
- Identify process development areas for improved efficiencies, yields, and/or cost of goods
- Plan, prepare, execute, and supervise hands-on activities following detailed protocols and SOPs, to complete process development runs in an efficient and safe manner
- Evaluate the results from process development studies to determine the appropriateness and timeline for GMP implementation
- Advise/consult with CMC team on technology transfer to/from CMOs and CTOs for GMP production and analytic testing
Education/Experience and Skills Requirements:
- A minimum of 3 years of cell and gene therapy manufacturing experience in the biopharmaceutical industry or an advanced scientific degree (PhD, PharmD, or MS) with 1 year of cell and gene therapy manufacturing experience
- Extensive experience with primary cell manipulation, enrichment methods, and genetic modification procedures
- Understanding and proficiency with a broad spectrum of cell and viral vector-based analytical techniques
- Excellent attention to detail, communication, time management, organizational skills and flexible attitude with respect to work assignments and new learning with proven ability to interact in a team environment
- Comfortable in a fast-paced small company environment with ability to manage a variety of projects simultaneously and handle rapidly changing information
- Self-starter and must function well under minimal supervision
- Expert MS Office skills with a specific focus on word processing, formatting, tables, spreadsheets, presentations, graphics, slides and templates, in addition to Adobe Acrobat
- Ability to effectively lead
- Ability to develop and execute strategies
- Handle issues appropriately and with a sense of urgency
- Strong leadership to support a multi-project environment in small biotech or large pharma
- Ability to interact, cooperate and motivate across departments and functions
- Ability to stand/sit for up to 8 hours
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 a company bringing hope and relief to patients with undertreated rare diseases through the development and commercialization of curative first-in-class gene therapies. www.rocketpharma.com.
Interested in joining our team? Contact us today!
Resumes with cover letters may be submitted to firstname.lastname@example.org