Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at www.cresilon.com.
- Serve as Cresilon’s Subject Matter Expert (SME) and technical lead in Current Good Manufacturing Practices (cGMP) analytical chemistry.
- Work as SME with FDA and other 3rd Party testing facilities.
- Ensure analytical methods are validated and analytical instrumentation are qualified to an extent commensurate with their risk and/or impact to product quality and patient safety. Ensure these activities comply with applicable requirements, including USP.
- Handle multiple project assignments of significant scope and technical complexity pertaining to analytical chemistry.
- Establish methods for material identification, material impurity identification, and material composition and quality evaluation, as applicable.
- Generate, review, and approve cGMP data pertaining to analytical chemistry in accordance with Good Documentation Practices (GDP).
- Perform method transfer to/from R&D and to/from external laboratories.
- Qualify analytical instrumentation in partnership with Quality Engineering.
- Validate analytical methods in partnership with Quality Engineering and R&D.
- Summarize analytical chemistry test data, including but not limited to maintaining lot histories and trend analysis for prospective non-conformance evaluation.
- Establish cGMP documentation, including but not limited to procedures, protocols, and reports, pertaining to analytical chemistry.
- Perform compliance activities, including but not limited to investigations and CAPAs, pertaining to analytical chemistry. Review and approve all compliance activities involving analytical chemistry.
- Execute routine analytical testing
- Mentor and train staff on cGMP analytical chemistry expectations.
- Collaborate cross-functionally within Cresilon and with external parties to achieve outcomes.
- Support laboratory operations by scheduling, planning, and executing applicable operations.
- Identify, coordinate, and manage external testing as necessary.
- Related duties as assigned.
Requirements
Education: Bachelor’s degree in chemistry, biochemistry, or related life-science discipline (Masters or Doctorate in analytical chemistry preferred)
Preferred Qualifications:
- 7+ years in medical device / pharmaceutical analytical chemistry quality control (10+ years preferred)
- 4+ years of analytical chemistry method validation (7+ years preferred)
- 4+ years of analytical chemistry method development (7+ years preferred)
- Pharmaceutical and/or medical device analytical chemistry
- Experience with FDA submissions and FDA clearance on device/product
- Technical problem-solving using science and engineering principles
- Good Documentation Practices (GDP) and data integrity
- Analytical method validation per USP
- Analytical instrument qualification per USP
Proficiency
- Applicable cGMP medical device requirements from USA 21 CFR § 820 and ISO 13485
- Physical characterization methods and physical method validation
- Laboratory Information Management Systems
- Minitab, Excel, or other statistical software
General
- Pharmaceutical and/or medical device microbiology
- International cGMP requirements
- Medical device risk management requirements per ISO 14971, including risk analysis tools such as FMEAs and RCA
- Electronic Quality Management Systems
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
- 401(k) & Roth Retirement Savings Plan with company match up to 5%
- Monthly MetroCard Reimbursement
The salary range for this role is $100,000-$135,000
Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.
