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. This individual will play a critical role in ensuring the safety, identity, purity, potency, and overall quality of our drug substance and drug product.

The Quality Control Analyst is responsible for executing GMP analytical testing for release and stability, supporting product characterization, and maintaining rigorous compliance with FDA and cGMP standards. This role requires strong technical expertise in molecular and cell-based assays, deep knowledge of GMP documentation standards (including ALCOA+ principles), and the ability to independently drive investigations and process improvements in a regulated environment.

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.
• Compile QC data, perform data trending, and control chart monitoring.
• 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.
• 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.

• 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.

• 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