Director Of Quality Control

Direct Biologics is a market leading innovator and science-based cGMP manufacturer of regenerative biologic products. We are currently looking for a Director of QC, responsible for:
Direct all Quality Control Activities

• Drive purchase of supplies, materials, and equipment.
• Responsible for Material Management
• Responsible for sample inventory.
• Onboard and train QC Analysts
• Supervise staff and communicate with other departments on schedule.
• Responsible for all invalid testing and OOS investigations.
• Manage QC related CAPAs and deviations.

Manage the analytical testing of products (in-process, for information, and release)

• Review the testing schedule with the QC Supervisor
• Perform day to day analytical testing activities in GMP QC lab to support the on-time release and periodic testing of biological drug products using complex instrumentation and laboratory equipment's per regulatory/quality policies.
• Prepare, analyze, review, troubleshoot, and evaluate a wide array of GMP assays per protocols and procedures.
• Supervise QC analyst(s)

Responsible for QC data/records to ensure content adheres to established cGMP quality standards.

• Manage Data Integrity and storage of original source data.

Responsible for QC Laboratory and Equipment maintenance and qualification.

• Manage Equipment calibration, maintenance, and qualification schedules
• Maintain equipment and cleaning records.
• Responsible to maintain equipment and use logs.

Partner with R&D and other departments in the design, testing, evaluation, and improvement of processes and controls.

• Establish statistically sound specifications.

Prepare Certificate of Analysis for product release
Manage the stability program, testing timepoints, and stability reports.
Create and update QC procedures and forms. Serve as SME (Subject Matter Expert) for QC testing and collaborate for transfer, and release activities.

• Representative for QC for all internal audits and Regulatory Inspections.

Ensure strict adherence to EPA, OSHA, and FAA safety and clean environmental guidelines.
Requirements

• Experience with human cell culture, protein assays (plate based ELISAs, immunostaining-based assays, fluorescent microscopy), quantitative PCR, RNA and protein isolation and quantification methods required.
• Familiarity with cGMP Quality Control Testing, Qualification, and validation of analytical test methods compliant to Good Laboratory and Documentation Practices.
• Strong verbal and written communication skills in cross-functional team setting.
• Must be highly flexible to respond to urgent needs and directional changes in a start-up environment but also have the attention to detail required to execute studies that will be reviewed by the FDA and other regulatory authorities.
• Lead GMP QC investigations and provide solutions to issues including OOS, deviations and/or CAPA.
• Ability to maintain lab equipment including qualification and calibration.
• Perform various mathematical calculations including subtraction, addition, multiplication, division, and statistical analysis including means, standard deviations, coefficient of variation (% std dev).
• Technical understanding and working knowledge of contemporary molecular biology, cell biology, microbiology and/or biochemistry.
• Education: MS in Biotechnology, biomedical engineering, cell and molecular biology, biochemistry, or other similar biology related majors, or equivalent work experience.
• Minimum of 10 years biotech based-work experience in cell culture, biochemical, or molecular biology GMP QC testing preferred.
• Experience in a GMP QC and regulated work environment.
• Experience with FDA inspections.

Benefits

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