Chemistry Manufacturing and Control (CMC) Program Manager
Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.
In particular, Matinas is developing a portfolio of products based upon its proprietary lipid nanocrystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them orally bioavailable, less toxic and targeted to cells and tissues.
This position is located in Bridgewater, NJ but we are conducting a nationwide search for qualified candidates.
The Chemistry Manufacturing and Control (CMC) Program Manager will provide project management support to our CMC team. In conjunction with internal subject matter experts and consultants, The Program Manager will be responsible for managing the planning (including timelines, costs, and resources) and on-time completion of product development activities from discovery hand-off through NDA submission and approval. The Project Manager will report to the Director, Program Management. The successful candidate must possess a strong technical understanding of the inter-disciplinary nature of drug development, demonstrated with previous drug development and/or manufacturing experience. The position will require timeline and deliverable management with close collaboration with CMC team members to ensure timely development, manufacturing, testing of drug substance and drug product, regulatory submissions, and supply of clinical trial material.
Specific Job Responsibilities
- Provide project management support for CMC and supply chain activities to support development, manufacturing, release and shipments of drug substance and drug product, analytical method development and transfer, stability, and supply chain related activities
- Facilitate planning of CMC activities across drug substance, drug product and clinical supply chain to align dependencies, schedules, and delivery commitments
- Create, manage, and facilitate regular meetings, including the development of agendas, issue written minutes, and follow up on action items
- Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s)
- Develop project plans with minimal support from others and works closely with project leads and/or department head
- Supports CMC project lead/department head with the optimization of CMC project deliverables (schedules, resources, budgets)
Experience and Skills
- S. degree in scientific field and > 5yrs of PM experience at biotech or pharmaceutical company with direct involvement in the CMC area
- Experience working in cross functional teams
- Experience with budget planning
- Experience with IND submission process
- Excellent interpersonal and organizational skills
- Excellent written and verbal communication skills
- Expert knowledge of MS Project and proficient in MS Office
- Understanding of GMPs, GLPs and Biopharmaceutical Product Development
- Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
- Must have the ability to build and maintain positive relationships with management and peers
- Ability to work on site
- Ability to work in a matrix reporting structure
- NDA management/coordination experience
- Strong technical understanding of inter-disciplinary nature of drug development, contract manufacturing, analytical development, document control, technology transfer, and CMC regulatory filings
- Experience in a GMP environment; both drug substance and drug product manufacturing in prescription drug setting
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