Direct Biologics, LLC is a rapidly growing biotechnology company specializing in advanced regenerative medicine therapies. We are currently seeking a highly skilled and motivated Quality Control Analyst to join our team. As a Senior Quality Control Analyst, you will play a crucial role in ensuring the safety, efficacy, and quality of our late-stage product.

In this role, you will be responsible for conducting comprehensive analysis of our product using state-of-the-art laboratory techniques and complex equipment. You will collaborate closely with cross-functional teams including Research and Development, Process Development, Manufacturing, Quality Assurance, and Regulatory Affairs, with attention on compliance with industry standards and regulatory requirements. Your primary focus will be on method transfers and product characterization, additional tasks include stability and release testing.

Primary Role 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 Development and other departments in the design, testing, evaluation, and improvement of processes and controls.

• Support Process 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 5-7 years of experience in a Quality Control role within the pharmaceutical or biotechnology industry performing GMP analytical product testing and/or analytical development.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Company 401k match up to 4%
• Paid Time Off (Vacation & Sick)
• Holidays
• Stock Option