3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow replacement of each individual patient’s parts with tissues designed and created specifically for them. 3DBio has developed unique technology platforms for the development of living tissue implants for therapeutic applications.
The Quality Control Manager leads all Quality control activities for biologics, devices, and combination products for 3DBio and also manages the respective instrumentation and methodology development. This position supports cGMP release and stability testing of product, transfer and validation of analytical methods. Maintains laboratories in a state of GMP readiness. This SME Manager role will also be required to perform analytical testing. and provides SME analytical testing support including the execution of analytical testing.
Establish and Manages a GMP QC biochemistry\biologics and device, laboratory testing environment.
Manages the activities of QC in conjunction with supervisory and analytical staff (scheduling and assigns/prioritizes laboratory activities), performs analytical testing where appropriate, and manages inspection and compendial testing on chemical/ products and raw materials.
Manages, reviews, and/or performs Quality Control system activities such as in-process, release, and stability testing, information management, investigations, method validation, method transfer, instrument qualification, corrective actions / preventive actions management. Authors and approves SOPs, protocols, reports, and data summaries.
Represents QC cross-functionally, provides technical subject matter expertise based on experience with release and stability testing, applies sound scientific judgment based on experience and knowledge of manufacturing and laboratory testing operations.
Develops and implements QC-related components of quality management systems aligned with project schedules. Oversees the effective utilization of QMS by laboratory personnel, develops and maintains compliance metrics, and reports to management.
Maintains and improves Quality Control GMP compliance and documentation, ensures data integrity of QC data for support of regulatory submissions.
Works in collaboration with internal Quality Assurance, Manufacturing and Contract Manufacturing, and Testing Organizations to develop and maintain robust systems for sample tracking, data handling, and reporting of metrics. Proposes and supports continuous improvement projects within QC.
Accountable for thorough, well-documented, and timely laboratory deviation/investigation reporting. Assembles and report laboratory metrics outside the QC organization.
Effectively utilizes Change Management to develop and execute continuous improvement initiatives within QC.
Authors/reviews applicable sections of regulatory documents as needed, support responses to questions from regulatory authorities, and represents QC during inspections.
Carries out direct supervisory responsibilities where applicable. Responsibilities include interviewing potential employees; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining.
Assures in collaboration with Quality Assurance that applicable employee training is completed and documented.
SME in cGMP/ISO vendor audits, as required.
Bachelor’s degree in biochemistry, biology, or related disciplines and 7-10 years of experience in a Biologics, Biopharmaceutical, and/or Biotechnology environment; or equivalent combination of education and experience.
Prior experience working in a cGMP environment required.
Must be proficient with QMS deployed to support GMP quality operations
Experience with leading development and implementation of methods used in the testing of Biopharmaceutical products raw materials based on FDA/ICH guidelines and respective compendia.
Familiarity with content and providing strategic support for submission of regulatory documents and responses.
Excellent oral and written communication, organizational, and interpersonal skills with the ability to multitask while working under restrictive timelines.
Ability to effectively manage and perform job responsibilities under minimal supervision.
About 3D Bio Therapeutics
3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow replacement of each individual patient’s parts with tissues designed and created specifically for them.