Chemist (Bridgewater)

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 :

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.

Chemical processing equipment set up and maintenance

Planning and execution of various chemical reactions

Designs of Experiment

Statistical process analysis

Design Verification testing

Internal / external communications with 3

rd

party vendors

Creation and management of required materials and process specifications

Leverages and applies fundamental chemistry, chemical engineering and manufacturing rigor to all development of products and processes, such as :

Material and chemical processing techniques

Raw material and coating characterization

Reaction thermodynamics and kinetics

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 :

• Find solutions to our patients unmet clinical needs and advocate for their cause.
• Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently.
• Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance.
• Fulfill our employees desire to make a difference in the lives of the patients they serve while achieving their own professional growth.
• Deliver value to our customers and shareholders.