Responsibilities include:• Manages overall coaching, training, development and succession plans for individuals and teams.• Advises top management about quality assurance concerns to determine resources needed to meet strategic objectives.• Identifies long-term quality objectives for division with specific annual objectives for each business unit.• Ensure appropriate system for the development, preparation, review, approval and distribution of specifications, test methods and stability protocols, in liaison with Quality• Ensure compliance to specification and applicable regulations emphasizing prevention rather than correction and minimize risks in all areas from Research and Development activities through manufacturing and distribution and marketing of products.

Responsible for the technical development of products, transfer from development to production, and production in support of products related to Affinity's services. Plays a lead role in R&D activities including transfer of developed products to production by providing technical and production/quality expertise. Responsible for coordinating assay/production testing under research and GLP/GMP conditions, planning production, interacting with clients/vendors, and manage Affinity personnel.

cGMP Manufacturing (development to packaging including biopharmaceuticals), experienced in working with antibody/antigen purification/conjugation and biotinylation, ELISA development/optimization, FPLC, HPLC, microbiological sampling, reviewing and preparing documentation including SOPs, Work Instructions and other Quality documentation, cell culture, QC documentation and testing, purchasing and logging in of materials and key equipment, Gel electrophoresis, Western Blot analysis, sample, buffer, and reagent preparation, instrument and equipment cleaning and maintenance, column chromatography, lyophilization.

Cryogenic Freezing of Embryo Lines, Media Making, Animal care and husbandry, Injections, Surgery Prep, Post-Op Checks, Autoclaving, Filing, Use of Data Spreadsheets, Extensive Microscopy, GLP’s.

Fill Prescriptions, Tend to Patients, Cashier Work, and Cleaning the Pharmacy