What are the responsibilities and job description for the Polymer Engineer position at Fusion Life Sciences Technologies LLC?
Title: R&D Process leader
Location: Raritan NJ.
You will be responsible for:
- Lead process design efforts from modeling through to pilot scale and qualification, including technical reviews.
- Collaborate with external suppliers, CDMOs and manufacturing facilities to develop processes. Drive selection of lab scale and pilot scale equipment.
- Drive process and product characterization to ensure rigorous technical understanding meets scale-up metrics and KPIs (such as scrap, cost and quality)
- Lead raw material suppliers through raw material iterations, correlating to product design window
- Drive execution of Learning Plans, seamlessly collaborating with Supply Chain
- Peer review, coach and develop earlier in career engineers with respect to Process Design
Qualifications
- Experience: 15-20 years required.
- Successful experiences in scaling up multiple new formulations (from modeling through to production scale) is required. Experience in biomaterials and material development highly preferred
- Successful qualification of multiple production lines is required
- Experience in reactive chemistries – highly preferred
- Experience in distillation design – highly preferred
- Experience in liquid and powder purifications is highly preferred
- Experience with instrumentation, automated control loops and semi-continuous processing is preferred
- Experience with vacuum system design is preferred
- Experience with NFPA regulations for flammable materials is preferred
- Experience in the Medical Device industry is preferred, not required; experience in combination products is preferred, not required.
- Proven problem-solving skills using analytical technologies is preferred
- Experience in the following processes (at multiple scales) is required: Powder handling, filling, mixing, transport, isolation, polymer synthesis and reaction (more may be added)
- Experience Design of Experiments (DOE) is highly preferred
- Experience in developing protocols and writing completion reports is preferred.
- Experience in vitro and ex vivo methods for characterizing prototypes and products is preferred
- Excellent communication, collaboration and influencing skills
- Demonstrated ability to deliver project outcomes in an ambiguous environment
- Travel up to 20% may be required (domestic and international)
Education:
- Bachelors degree in the following is required Chemical Engineering or Polymer Engineering: Advanced degree is highly preferred.
- Experience in Polymer Manufacturing is required.