Job Description

Cresilon, Inc is a medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal health industry that aim to solve problems associated with wound healing. We have created a hemostatic device that can instantly stop traumatic bleeding. Please refer to these associated links to learn more about Cresilon:

The Scientist is responsible for leading product design and development activities related to polymer materials development and their use, with compliance to all quality and regulatory requirements. The position has a scientific focus that includes formulation development, characterization and implementation including proto-type design and fabrication and data generation through designed experiments. The Scientist will work in a multidisciplinary team of researchers. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of product innovation and robustness.

The Scientist is expected to be subject matter expert on but not limited to analytical chemistry, biomedical engineering, and polymer material science. The Scientist is expected to drive adherence to high standards of research work. They are responsible for leading efforts creating documentation necessary for regulatory submissions, grant/publication strategy, securing of non-dilutive funding through grant opportunities, and communicating directly with the Director of Research on all other tasks.

This is a full-time, on-site position, located in Brooklyn, New York. Level will be contingent on education and prior industry experiences.

Responsibilities

• Create and lead experimentation for exploratory and product development research with focus on polymeric materials and their use.
• Exercise technical judgment in the design, execution and interpretation of experiments within the scope of project responsibilities and ensure the use professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures.
• Process and analyze results, with the goal of interpreting data towards in-vitro replicability;
• Lead material/design/process changes through design control process, with well-documented research/analyses.
• Author protocols and reports including development studies and design verification/validation activities.
• Develop and execute of test methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes.
• Prepare samples as required for testing, or other evaluations and data analysis.
• Participate in voice-of-customer (VOC) labs.
• Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication.
• Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines.
• Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions,
• Act as research liaison between Research and Quality Control to define product specifications.
• Maintain active dialogue with Manufacturing to ensure successful technology transfer and. process development; Review of Research-related documents
• Provide support to marketing and sales team, support introduction of new technologies with development of presentations, sales tools, formulations and applications data
• Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company.
• Manage part-time staff as a research leader and mentor for ongoing research projects.
• Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization.
• Provide other project or product support as needed in order to support Cresilon\xe2\x80\x99s business objective

• For Scientist I: BS in Chemical Engineering, Biomedical Engineering, Polymer Engineering, Material Science or related scientific discipline with 4+ years of product development experience OR

• MS in in Chemical Engineering, Biomedical Engineering, Polymer Engineering, Material Science or related scientific discipline with 2+ years of product development experience OR

• PhD in Chemical Engineering, Biomedical Engineering, Polymer Engineering, Material Science or related scientific discipline with 0+ years\xe2\x80\x99 experience.
• Minimum of 2 years of laboratory experience is required.
• For Scientist II: BS in Chemical Engineering, Biomedical Engineering, Polymer Engineering, Material Science or related scientific discipline with 9+ years of product development experience OR

• MS in in Chemical Engineering, Biomedical Engineering, Polymer Engineering, Material Science or related scientific discipline with 7+ years of product development experience OR

• PhD in Chemical Engineering, Biomedical Engineering, Polymer Engineering, Material Science or related scientific discipline with 2+ years\xe2\x80\x99 experience.
• Minimum of 5 years of laboratory experience is required
• Experience in an industry setting within cGMP regulated environments is strongly preferred.
• Minimum of 2 years of work experience with medical device or pharmaceutical experience is preferred.
• Adept experimentalist with hands-on experience in product development of polymeric materials and their characterization in an R&D is required, including the ability to develop polymer structure-property-performance relationships and design polymeric materials to desired properties.
• Requires an understanding of rheology, material science, and biomedical and chemical engineering. Individuals with process development experience preferred.
• Demonstrated expertise in the use and development of material characterization techniques, including rheological, thermal, mechanical, spectroscopic, microscopic and other chemical compositional methods is highly preferred.
• Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements along with the fundamental understanding of the chemistry that drives the performance required. This includes strong analytical, problem-solving and decision-making skills with the ability to be observant and to think creatively required.
• The ideal candidate will have a track record (i.e. academic papers and/or patents) of applying their subject matter expertise to solve problems in the application areas such as functional coatings, adhesives, hydrogels, sealants, biomaterials, films and foams.
• Experience writing highly technical grants for submission to federal agencies is strongly preferred
• Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies is required. Six sigma green belt or black belt certification preferred.
• Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross-functionally to expedite completion of critical project tasks is required.
• Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner is required.
• Ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills is required.

• Working knowledge of FDA requirements as per 21 CFR 820 and ISO 9001, ISO 13485:2003 and ISO 14971:2007 preferred.
• Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP) preferred.
• Experience should include method development/validation and/or transfer/verification, protocol development, and troubleshooting skills.
• Requires strong leadership skills, excellent written and verbal communication and presentation skills.
• Proficient in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required.
• Legal authorization to work in the United States is required.

• Competitive annual base salary range of $60,000 - $120,000, depending upon job level and qualifications
• Paid Vacation and Holidays
• Medical, Dental, and Vision Insurance
• Company Paid Life and Short-Term Disability Coverage
• 401(k) Retirement Savings Plan with company match

Cresilon, Inc.