Job Summary
The Onkos Chemist/Process Chemist is responsible for the early and mid stage coating, raw material and general chemistry development of the NanoCept TM antibacterial coating technology and associated products, through the use of chemistry, chemical engineering and manufacturing principles and internal customer input to achieve the program deliverables (e.g. quality, cost, and delivery). The Chemist leads the hands-on aspects of the NanoCept chemistry process development, raw material development and test piece coating needed to generate performance data to secure regulatory clearance and eventual commercialization of Onkos’ antibacterial coated implant systems. They develop and support process chemistry development, raw material, and analytical processes as they relate to NanoCept coating process and implant testing efforts, conduct process remediation exercises when necessary, root cause and engineering analyses, and work with R&D and Regulatory on design for manufacturability, quality testing, and inspection. They provide focused and expert support of the efforts centered around new material/product research and development, and associated pre-clinical testing critical for regulatory clearances.
Responsibilities
· Works with multidisciplinary project team to develop, implement, and facilitate the following for FDA clearance of safe and effective technology and products:
Ø NanoCept chemical process coating development, part coating and evaluation, and technology transfer with a particular focus on the chemistry and chemical engineering aspects of the coating process and post processing such as packaging and sterilization.
Ø Chemical processing equipment set up and maintenance
Ø Planning and execution of various chemical reactions
Ø Designs of Experiment
Ø Statistical process analysis
Ø Design Verification testing
Ø Internal / external communications with 3 rd party vendors
Ø Creation and management of required materials and process specifications
Ø Leverages and applies fundamental chemistry, chemical engineering and manufacturing rigor to all development of products and processes, such as:
Ø Material and chemical processing techniques
Ø Raw material and coating characterization
Ø Reaction thermodynamics and kinetics
Ø Leads process risk analysis via FMEA
· Generates process quality requirements
· Generates regulatory related documentation and testing protocols
· Assist in preparing comprehensive project timelines with technical objectives, milestones (timing, resource requirements, costs, etc.).
· Seek out new technologies for materials and processing through 3 rd party relationships.
· Ensures work output is compliant with all current regulatory and quality standards.
· Completes all required training in timely fashion.
· Other requirements as project needs dictate
Requirements
· A minimum of three years of successful chemistry or chemical engineering related technology development in the industrial chemicals, medical device, or pharmaceutical field
· Experience with chemical process development and chemical engineering practices
· Minimum of BS degree in Chemistry or Chemical Engineering, ideally monomer and polymer synthesis through wet chemistry means
· Ability to apply analytical skills, in solving chemistry or chemical engineering problems and developing new technologies
· Demonstrated knowledge of statistically driven Designs of Experiment.
· Demonstrated computer skills including spreadsheets, word processing, database and other applicable software programs.
· Excellent interpersonal skills; self-motivated and flexible to changing schedules.
· Strong attention to detail, good oral and written communication skills
About Onkos Surgical
At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause.
We exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients.
At Onkos Surgical, we will:
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