QC Manager, Analytical

San Diego, CA

Quality – Quality Control /

Full Time /

On-Site

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The Manager of Quality Control, Analytical is responsible for daily QC lab operations, coordination, and oversight of testing and reporting of results for raw materials, drug substance and drug product in-process, release and stability. The Manager of Quality Control, Analytical is also accountable for the oversight of method qualifications and validations, out of specification/anomalous results investigations, and will also lead process improvement opportunities; and supervise, mentor, train QC Associates.

• Provides supervision to QC staff to perform duties in support of manufacturing, in support of the facility, and as necessary development activities; ensures appropriate level loading and communication of priorities.
• Responsible for optimization and operation of the quality control laboratory in a biopharmaceutical manufacturing setting, including all related infrastructure, documentation, equipment validation and analyst training.
• Develops, implements, and maintains quality control systems in accordance with cGMP requirements.
• Develops and mentors staff to improve individual and departmental performance.
• Provides daily oversight of manufacturing support testing for multiple projects and related stability studies.
• Manages all aspects of Quality Control (QC), in support of Abzena GMP projects, and in full compliance with established cGMP and Abzena requirements.
• Leads the scheduling, level loading and forecasting sample receipt and testing for the analytical laboratory.
• Oversees and manages processes for the following:
• Test method verification, qualification, validation and/or transfer activities between Assay Development and QC laboratories
• Assay Performance Qualification and Continued Assay Verification activities associated with QC laboratory testing
• Maintenance, calibration and qualification of laboratory instruments and equipment
• Ensuring adequate training (skills-based, cGMP and safety) of QC scientists and associates within the department
• Raw material, in-process, product release, stability and environmental testing
• Investigation of laboratory non-conformances (events, deviations, and invalid assays)
• Strategic capital projects for the QC labs
• Conducts investigations and resolves complex and non-routine issues.
• Interact closely with Manufacturing and R&D Departments.
• Provides expertise in troubleshooting complex laboratory issues and demonstrates strong reasoning skills in support of ongoing laboratory investigations.
• Manages cGMP release and stability testing at Abzena, SS and contract testing laboratories.
• Manages the implementation, qualification, validation and transfer of client's product specific
• methods.
• Authors and reviews Quality Control Standard Operating Procedures (SOPs), Assay Qualification and Stability Protocols.
• Reviews and approves Standard Test Methods, Technical and Stability Reports.
• Assists in investigation and review of deviations, change controls, CAPAs, OOT/OOS thru GMP Quality System.
• Maintains and monitors client's product stability programs.

• B.S. or higher degree in Biology, or related Life Sciences degree with at least 7+ years of experience working under GMP and at least 0-3 years managerial experience.
• Practical knowledge in all aspects of product development from investigational phase to commercial launch including method development, tech transfer, phase appropriate validation and CMC submissions.
• Experience in the establishment and operation of QC laboratories in a GMP regulated environment.
• Extensive knowledge of U/HPLC, UV-Vis, FTIR, SDS-PAGE, ELISA, CE, and compendial assays
• Knowledge of regulatory guidelines relating to method qualification and validation
• Proven leadership and motivational capabilities.
• Experience with Data Trending and control chart interpretation.
• Knowledge with managing stability programs is desirable.

$100,000 - $140,000 a year

FLSA: Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.