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 Manager of Outsourced Testing to join our team. As the Quality Control Manager of Outsourced Testing, you will play a crucial role in ensuring the safety, efficacy, and quality of our early to late-stage products and preparing comprehensive data packages for critical quality review for batch release.

In this role, you will be responsible for managing the comprehensive analysis of our product by working directly with our vendors. You will also 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 directly managing the quality outsourced release testing of manufactured product by creating and maintaining vendor project plans, developing and reviewing metrics, and building vendor relationships that support quality product release. Additional tasks include the management of timepoint testing for stability programs.

Primary Roles and Responsibilities:

• Manage drug substance, drug product, and raw material testing at external contract testing laboratories, for a range of analytical techniques, such as adventitious agent testing, rapid mycoplasma PCR, nanoparticle tracking analysis, analytical chemistry analysis, quality vial inspection methods, and USP methods for the generation of a successful investigational medicinal product (IMP) quality release package.
• Ensure compliance with all applicable regulatory guidelines and standards, including FDA requirements.
• Drive an internal cross-functional team for the evaluation, documentation, and timely response to investigations and deviations generated by outsourced testing laboratories.
• Lead cGMP activities to improve existing sampling plans and create new sampling plans as needed which include all applicable tests. Ensure sample volumes and quantities are justified while adhering to phase appropriate timelines for method validation or verification, and sample qualification.
• Plan for future manufacturing campaigns’ testing needs and collaborate with vendors for successful timeline adherence.
• Generate test requests, sample submission forms, and coordinate the shipment of samples to external contract testing vendors.
• Ensure adherence to timelines for Stability protocol and ICHQ1A(R2) testing frequencies.
• Regularly update and maintain the test results matrix for outsourced assays.
• Maintain quality metrics for vendor adherence to Quality Agreements, Master Service Agreements, and Statement of Work.
• Compile QC Certificate of Testing (COTs) and Certificate of Analysis (COA). Drive internal reviews for accuracy and adherence to Specifications.
• Attend all Vendor Quality meetings, Joint Steering Committee meetings, and Vendor Quality Audits.
• Support Process Development with management of outsourced development studies.
• Maintain records for the lifecycle of the product testing plan. Issue change controls to document outsourced product testing changes.
• Maintain an ever-ready qualified state to ensure accurate and reliable results.

Skill Requirements:

• A strong Quality Control background for the testing of sterile injectable products.

• Strong technical understanding and working knowledge of analytical testing in highly regulated environments.

• Highly experienced with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).

• Excellent attention to detail and analytical skills, with the ability to interpret and present data effectively.

• Advanced skills in the management of commercial product outsourced testing programs.

• Excellent organizational, strategic planning, and project management abilities to meet deadlines in a fast-paced environment while managing multiple vendor relationships.

• Experienced in cGMP, OOS, deviations, and CAPA documentation with the capability to evaluate vendor quality events and assemble the appropriate cross-functional team members for timely responses.

• Ability to work independently as well as collaboratively in a team-oriented setting.

Requirements

• Bachelor’s degree in Biotechnology, biomedical engineering, cell and molecular biology, biochemistry, or other similar biology related majors.
• Advanced degree preferred
• Minimum of 5 years of experience in a Quality Control Management role within the pharmaceutical or biotechnology industry with outsourced GMP analytical product testing.

Benefits

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