Vacancy expired!
- Lead technical development of drug-device combination products.
- Develop technical solutions and perform data analysis supporting product development, novel technologies, intellectual property disclosures, and project proposals.
- Author technical documents including project reports, presentations, and CMC summaries. Write and revise manufacturing procedures, test methods, standard operating procedures, protocols, and other Quality System documentation.
- Conduct or lead research on technology of strategic interest for new technologies or intellectual property disclosures. Present work internally and externally.
- Specify, qualify, and validate equipment and processes.
- Contribute to troubleshooting and maintenance of equipment and plant. Maintain a safe, clean, and compliant work area.
- Effectively balance project needs, priorities, and status of multiple projects. Communicate status and needs across the organization to ensure project success.
- Collaborate constructively with internal and external stakeholders to plan, execute, and complete work with a high degree of autonomy. Review work of colleagues. Lead, train, and mentor junior staff.
- Provide technical consultation and support to both Operations and external departments, and work direction and mentoring to junior-level Scientists as required.
- Maintain positive, respectful, professional relationships with internal team members and external contacts to drive projects forward.
- Demonstrate unquestionable integrity, credibility and character. Act as a positive role model for other employees.
- May supervise one or more technicians or junior scientists/engineers
- Comply with applicable FDA and international regulatory laws/standards and the company Code of Conduct.
- Provide technical consultation and support to both Operations and external departments, and work direction and mentoring to junior-level Scientists as required.
- BS in Chemistry, Engineering, or other technical discipline with 8+ yrs of experience (MS with 5+ years, Ph.D. with 3+ yrs).
- An aptitude for research in the medical device and pharmaceutical industry.
- Ability to work with passion, enthusiasm and high energy in a fast paced, customer-oriented team environment.
- Substantial knowledge and experience in the fields of materials science, chemistry, and/or polymer science.
- Experience with long term drug delivery systems a plus
- Familiarity with various polymer processing techniques including extrusion, injection molding, and compression molding.
- Excellent project management skills
- Experience in an FDA/MDR regulated environment.
- Understanding of medical device design control / quality systems and the product development process (PCP).
Vacancy expired!