About Direct Biologics:
Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust extracellular vesicle based biologic platform technology. The Company is committed to providing the latest clinical and scientific information through rigorous and thorough research. With deep knowledge and industry expertise in cellular and regenerative therapies, the company has brought to market a significant development in therapeutic biologics with the introduction of the highest quality production of extracellular vesicles.
Primary Roles and Responsibilities:
- Perform day to day analytical testing activities in GMP QC lab to support the on-time release and periodic testing of biological drug products using complex instrumentation and laboratory equipment’s per regulatory/quality policies.
- Prepare, analyze, review, troubleshoot, and evaluate a wide array of GMP assays under established protocols and procedures.
- Compile and maintain QC data/records to ensure content adheres to established cGMP quality standards.
- Ensure strict adherence to EPA, OSHA, and FAA safety and clean environmental guidelines.
- Serve as SME (Subject Matter Expert) for QC testing and collaborate for transfer, and release activities.
- Partner with R&D and other departments in the design, testing, evaluation, and improvement of processes and controls.
- Support R&D with additional studies
Requirements
- Experience with human cell culture, protein assays (plate based ELISAs, immunostaining-based assays, fluorescent microscopy), quantitative PCR, RNA and protein isolation and quantification methods required.
- Familiarity with cGMP Quality Control Testing, Qualification, and validation of analytical test methods compliant to Good Laboratory and Documentation Practices.
- Strong verbal and written communication skills in cross-functional team setting.
- Must be highly flexible to respond to urgent needs and directional changes in a start-up environment but also have the attention to detail required to execute studies that will be reviewed by the FDA and other regulatory authorities.
- Lead GMP QC investigations and provide solutions to issues including OOS, deviations and/or CAPA.
- Ability to maintain lab equipment including qualification and calibration.
- Perform various mathematical calculations including subtraction, addition, multiplication, division, and statistical analysis including means, standard deviations, coefficient of variation (% std dev).
- Technical understanding and working knowledge of contemporary molecular biology, cell biology, microbiology and/or biochemistry.
- Education: BA or MS in Biotechnology, biomedical engineering, cell and molecular biology, biochemistry, or other similar biology related majors.
- Minimum of 2 years biotech based-work experience in cell culture, biochemical, or molecular biology GMP QC testing preferred.
- Experience in a GMP QC and regulated work environment strongly desired.
Benefits
- Salary Range: $50,000 – $70,000 annually
- Health Care Plan (Medical, Dental & Vision)
- Company 401k match up to 4%
- Paid Time Off (Vacation & Sick)
- Holidays
- Stock Option