Location: Cranbury, NJ
Travel Requirements: <10%
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 proactively manage multiple CMC projects coordinating with key internal and external stakeholders to advance our transformative cell- and gene-based therapies. The primary responsibility of this position is to work collaboratively with and focus on effective communication, planning, coordination of activities, and efficient implementation of the CMC development and supply strategy. This will include working with internal CMC, clinical, and regulatory groups, external academic partners, and contract manufacturing organizations (CMOs) and contract testing organizations (CTOs). The ideal candidate for this position will have demonstrated experience of integrated program/project management preferably in the biotechnology/biopharma industry. 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.
- Develop CMC project plans for multiple existing and envisioned projects
- Manage external contract manufacturing organizations (CMOs) and contract testing organizations (CTOs) for the manufacturing and timely release of ex vivo lentivirus drug product
- Establish, document, track and communicate CMC timelines, objectives, deliverables, and budgets
- Create project communication tools, such as project dashboards, CMC team meeting minutes and summaries, resource and timeline plans and staffing to accomplish these plans
- Assist with cross-functional project team meetings and drive on-time completion of deliverables
- Facilitate project discussions to ensure progress and identify appropriate team actions and risks
- Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate
Education/Experience and Skills Requirements:
- A minimum of a bachelor’s degree in biological sciences, bioengineering, or an associated discipline with 2 years of directly related experience
- Project Manager Professional (PMP) certificate or MBA is preferred
- Experience in the biotechnology or biopharma industry with a primary focus on project/program management of CMC related activities
- Experience utilizing project management tools and best practices to support CMC activities
- Experience managing CMO/CTO relationships and projects
- 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
Physical/Mental Requirements: (edit for job specific requirements)
- 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