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Senior Quality Control Chemist

2 months ago

Brooklyn, New York, United States Cresilon Inc Full time
About Cresilon Inc

Cresilon Inc is a leading biotechnology company that develops innovative hemostatic medical devices utilizing proprietary hydrogel technology. Our mission is to revolutionize the standard for stopping traumatic and surgical bleeds in seconds without manual pressure.

Job Summary

We are seeking a highly skilled Senior Quality Control Chemist to serve as our Subject Matter Expert (SME) and technical lead in Current Good Manufacturing Practices (cGMP) analytical chemistry. As SME, you will work closely with FDA and other 3rd Party testing facilities to ensure analytical methods are validated and instrumentation are qualified to an extent commensurate with their risk and/or impact to product quality and patient safety.

Key Responsibilities
  • Ensure analytical methods are validated and instrumentation are qualified to an extent commensurate with their risk and/or impact to product quality and patient safety.
  • Work as SME with FDA and other 3rd Party testing facilities.
  • 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.
Requirements
  • Bachelor's degree in chemistry, biochemistry, or related life-science discipline (Masters or Doctorate in analytical chemistry preferred).
  • 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.
  • 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.
  • Laboratory audits.
  • Proficiency in 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.
  • Microsoft Office suite.
  • QMS audits.
  • 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.
Salary Range

$100,000-$135,000.

About Cresilon Inc

Cresilon Inc 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.