Brammer Bio, part of Thermo Fisher Scientific is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.
This position will work in the GMP compliant QC Laboratories to develop, qualify, and conduct cell-based, nucleic acid-based, protein-based, and chemistry-based assays that support quality control of biopharmaceutical products being developed and manufactured. Will perform routine assays and testing including HPLC, PCR, real time PCR, agarose gel electrophoresis, SDS-PAGE, immuno blotting, ELISAs, immunocytochemistry, and infectivity and reporter gene based cell assays using insect or mammalian cell lines. This position will also troubleshoot and optimize assays under the supervision of the GMP QC Manager/ Research Coordinator. Functions also involve maintenance of cell lines used in the QC laboratories, maintenance (routine and preventive operation) of equipment, and preparation and purification of commonly used biological reagent and chemical supplies. The incumbent will be expected to technically interpret, write controlled documents and reports, and review data produced by self and participate in laboratory investigations. Will interact with other departments to ensure that sample flow, supply chain, and equipment disposition are correctly maintained.
- Contributes to the development of new concepts, techniques, and standards. Considered a consultant (expert) within the group. Has complete understanding and application of principles, concepts, practices, and standards. Oversight of complex functional group, often including junior management levels.
- Review IQ/OQ/PQ protocols and final reports for instrument system upgrades. Generate PQ protocols.
- Defines complex issues. Recommends and guides implementation of functional strategies across group.
- Completes tasks where judgment is required in resolving problems & making recommendations.
- Provides frequent overall departmental feedback to senior management.
ESSENTIAL JOB FUNCTIONS:
- Qualify, perform and evaluate the results of qPCR assays, infectivity assays including TCID50, and other assays related to the safety and release testing of intermediate and final biological products (toxicological and clinical materials), and their stability, manufactured by Brammer Bio. These assays must be performed according to written procedures and in compliance with cGMP regulations (35%)
- Qualify, perform and evaluate the results of gel electrophoresis assays, Western blot assays, quantitative protein assays, ELISAs, spectrophotometric assays, cell viability assays, infectivity assays and other assays related to the safety and release testing of intermediate and final biological products (toxicological and clinical materials), and their stability, manufactured by Brammer Bio in the Process Development labs (20%)
- Maintain complete and accurate records of all work performed. Maintain equipment records as required by procedure. Write planned variances, deviation reports, track stability data, write reports etc. in compliance with cGMPs (20%)
- Purify and test molecular biological reagents vital to the continued function of the cGMP QC labs (10%)
- May train, plan and direct the daily activities of junior staff. Directed activities are usually limited to assigning, monitoring and reviewing progress, and accuracy of work directing efforts & providing technical guidance on complex issues. Maintain appropriate in-house assay standards including inventory and database of each standard s performance in each assay (5%)
- Ensures adequate training (skills-based, cGMP and Safety) of Associates within department, to support commercial production and Pharmaceutical Development needs through highly competent staff. May supervise technical staff (5%)
- Miscellaneous tasks as necessary (5%)
EDUCATION AND QUALIFICATIONS:
- Bachelor s Degree in Life Sciences
- At least 8 years of related experience or equivalent combination of education & experience.
- Extensive knowledge of QC testing principles and procedures, as applicable to focus of position.
- Extensive exposure to cGMP environment. Audit experience.
- Knowledge of testing and associated equipment protocols and requirements and applicable instrumentation and procedures.
- Strong interpersonal and communications skills; written and oral.
- Solid understanding of applicable regulatory requirements.
- Significant laboratory documentation review and revision experience.
While performing the duties of this job, the employee:
- NeedsAbility to aseptically gown and/or sterile gown as needed
- Ability to work within environmental clean rooms or laboratory setting
- Ability to function in a dynamic environment and balance multiple priorities simultaneously
- While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
- Is regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods. The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.
Associated topics: aseptic, bacteria, biotechnology, genome, immunobioengineering, physical, physiology, protein, toxicologist, virus