Manager/Principal Scientist Research & Development - Polymer Formulation jobs in United States
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Cresilon · 3 weeks ago

Manager/Principal Scientist Research & Development - Polymer Formulation

Cresilon is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing proprietary hydrogel technology. The R&D Formulation Manager/Principal Scientist will lead the design and development of novel formulations and polymer materials for medical devices, ensuring compliance with quality and regulatory standards.

BiotechnologyHealth CareMedicalMedical Device
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H1B Sponsor Likelynote

Responsibilities

Lead, staff, and manage formulation development teams and their efforts across multiple parallel product development opportunities, to launch new commercially successful products
Provide sound scientific leadership, monitoring, and coaching through the initiation, planning and execution their team's overall activities
Create and lead experimentation for exploratory and/or 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 of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures
Lead material/design/process changes through design control process, with well-documented research/analyses
Review and author protocols and reports including development studies and design verification/validation activities
Develop and implement investigations into new technologies and capabilities, partnering with business development, that advance research team and company objectives
Lead efforts in chemical and mechanical property evaluation to assess the desirability of process or formulation changes. Develop test method capabilities to support R&D (exploratory research, product development) and production test requirements
Develop unique, proprietary (and ideally patentable) intellectual property that yields competitive advantage
Lead and participate in voice-of-customer (VOC) labs and influence go-to-market strategies
Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication
Work as part of a cross-functional team to develop, verify, and validate product designs through bench, in-vitro, and in-vivo testing and other assessments
Ensure an effective documentation system is in place and utilized throughout the development process inclusive of R&D lab notebooks, design reviews, test methods, and test reports
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 R&D and Quality Control to define product specifications
Maintain active dialogue with Manufacturing to ensure successful technology transfer and process development, including the review of research-related documents
Provide guidance and support to commercial teams, 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
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, product, or leadership support as needed to support Cresilon's business objective

Qualification

Polymer material scienceFormulation strategiesAnalytical chemistryBiomaterial interactionsNew product developmentRegulatory requirementsSix sigma certificationProject managementMicrosoft OfficeLeadership skillsProblem-solving skillsCommunication skills

Required

Master's degree in Chemistry, Materials Science, Chemical Engineering, Polymer Science, or a closely equivalent discipline
A minimum of 10 years of research experience in developing and utilizing polymeric materials, biomaterials, or other complex materials toward product/application development and their manufacture, with at least 5 years in a non-academic setting
A minimum of 2 years of direct management experience
Adept experimentalist with hands-on research experience with polymers, coagulation chemistry, and materials science of complex systems, including the development of structure-property performance relationships in designing and characterizing these materials
Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements, along with a 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
Direct experience in new product development from concept to regulatory approval through launch
Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies is required
Excellent verbal and written communication skills, with the ability to lead in a dynamic and collaborative environment is required
Highly organized and detail-oriented, with the ability to extract key facts from complex information and create/present clear and concise technical documentation is required
Demonstrated ability to lead and inspire teams and develop and mentor individuals, and allocate resources strategically and according to the portfolio priorities
Requires strong leadership and organizational skills with a strong attention to detail and multi-tasking skills while simultaneously keeping overall 'big picture' view of projects, priorities, and strategies
Experience working under pressure with tight timelines, with the ability to maintain a sense of priorities, focus, urgency, and delivery
Strong working knowledge of Microsoft Office
Legal authorization to work in the United States

Preferred

Ph.D. in a relevant discipline is strongly preferred
Experience developing and commercializing products in a highly regulated environment
Medical device development experience
Demonstrated expertise in the use, development, and qualification of material characterization techniques, including rheological, thermal, mechanical, spectroscopic, microscopic, and other chemical compositional methods
Strong understanding of medical device regulatory requirements for Class II and III medical devices (e.g., 21 CFR Part 820), cGLP/cGMP, and related standards (e.g., ISO 13485)
Strong understanding of cGMP, ICH guidelines
Six sigma green belt or black belt certification
Experience with executing a grant and publication submission strategy, knowledge of and strong track record with SBIR submissions to multiple agencies, including NIH and DOD is strongly preferred
Demonstrated experience in Project Management and Product Lifecycle Management practices, and the ability to lead multiple projects simultaneously
Excellent problem-solving skills and a proactive approach to addressing formulation challenges

Benefits

Paid Vacation, Sick, & Holidays
Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage
Company Paid Life and Short-Term Disability Coverage
Work/Life Employee Assistance Program
Monthly MetroCard Reimbursement
401(k) & Roth Retirement Savings Plan with company match up to 5%

Company

Cresilon

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Cresilon is a medical device company that produces and markets solutions for trauma care.

H1B Sponsorship

Cresilon has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2021 (2)

Funding

Current Stage
Growth Stage
Total Funding
$100.66M
Key Investors
Paulson Investment Company
2025-09-09Series Unknown· $23.86M
2022-10-27Series A· $25M
2021-04-08Series A· $14M

Leadership Team

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Isaac Miller
EVP, Co-Founder
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Scott Levine
Chief Financial Officer
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Company data provided by crunchbase