Quality Control Analyst - GMP Analytical & Molecular Testing

About Direct Biologics

Direct Biologics is a leading regenerative medicine biotechnology company dedicated to developing innovative, science-driven biologic therapies. Our team is committed to advancing high-quality, compliant, and clinically meaningful products that improve patient outcomes. We operate in a fast-paced, highly collaborative environment where quality, integrity, and scientific excellence drive everything we do. We are seeking a Quality Control Analyst who is self-driven, action-oriented, and committed to operational excellence.

Primary Roles And Responsibilities

• Perform day-to-day drug substance and drug product testing using a range of analytical techniques, such as plate-based ELISA, immunostaining assays, quantitative PCR, and methods for RNA and protein isolation and quantification.
• Ensure compliance with all applicable regulatory guidelines and standards, including FDA requirements.
• Lead cGMP method transfer activities from Development to Quality Control while providing regular progress updates to drive timelines.
• Conduct product characterization studies to assess the identity, purity, and potency of samples.
• Perform stability testing to evaluate the shelf-life and storage conditions of products.
• Prepare, analyze, review, troubleshoot, and evaluate a wide array of GMP analytical assays under established protocols and procedures following the change control process to implement process improvement and process change.
• Document and analyze test results, generating reports that provide clear and concise findings.
• Serve as SME (Subject Matter Expert) for QC testing and collaborate for transfer and release activities.
• Author SOPs and Test Records and Training Plans with a Quality-by-Design (QbD) mindset.
• Possess a deep understanding of GMP documentation standards (including ALCOA+ principles).
• Partner with Process and Analytical Development and other departments in the design, testing, evaluation, and improvement of processes and controls.
• Support Process and Analytical Development with additional studies.
• Maintain laboratory equipment in an ever-ready qualified state to ensure accurate and reliable results.

Requirements

• Strong knowledge of analytical techniques such as plate-based ELISA, immunostaining assays, quantitative PCR, and RNA and protein isolation and quantification methods.
• Strong technical understanding and working knowledge of contemporary molecular biology, cell biology, microbiology and/or biochemistry.
• Highly experienced with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) and authoring Quality Control protocols and reports.
• Excellent attention to detail and analytical skills, with the ability to interpret and present data effectively.
• Advanced data management encompassing various statistical analyses such as means, standard deviations, coefficients of variation (% standard deviation), and control charting. Familiarity with statistical software preferred.
• Strong organizational and time management abilities to meet deadlines in a fast-paced environment.
• Proficient in laboratory equipment and instrumentation operation and maintenance.
• Experienced in cGMP, OOS, deviations, and CAPA documentation with the capability to conduct root cause analysis.
• Ability to work independently as well as collaboratively in a team-oriented setting.

Qualification Requirements

• BA/BS or MS in Biotechnology, biomedical engineering, cell and molecular biology, biochemistry, or other similar biology related majors.
• Minimum of 3-7 years of experience in a Quality Control role within the pharmaceutical or biotechnology industry performing GMP analytical product testing and/or analytical development.

Benefits

• Salary Range: $75,000 - $95,000 annually
• Health Care Plan (Medical, Dental & Vision)
• Company 401k match up to 4%
• Paid Time Off (Vacation & Sick)
• Holidays
• Stock Option