Scientist I, QC- Alachua, FL

    • Job Tracking ID: 85430-272621
    • Job Location: Alachua, FL
    • Job Level: Any
    • Level of Education: Any
    • Job Type: Full-Time/Regular
    • Date Updated: 09/04/2018
    • Years of Experience: Any
    • Starting Date: ASAP
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Job Description

Brammer Bio is a rapidly growing, dynamic gene therapy contract development and manufacturing organization that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients.  Our employees are committed to making a difference in our organization, for our client partners and the patients we serve.  We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.

Job Summary:

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 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. 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. 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.

Essential Duties:

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.     

Qualify, perform and evaluate the results of qPCR assays, 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.     

Purify and test molecular biological reagents vital to the continued function of the cGMP QC labs.     

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.     

Maintain sample inventory system including daily database entries.  Participate in laboratory upkeep and required equipment calibration and preventive maintenance.   

Maintain appropriate in-house assay standards including inventory and database of each standard’s performance in each assay. 

Benefits:

Brammer Bio offers an attractive benefit package to all full time employees which includes; medical, dental, and vision coverage, company paid Disability and Life Insurance benefits, and a 401(k) Plan with a generous company match.  All full time employees are also provided with paid time off, paid company holidays, share appreciation rights, and an incentive bonus plan.

Brammer Bio is an Equal Opportunity Employer and participates in eVerify

Work Hours: Monday through Friday, 8:00 AM to 5:00 PM.  Requires overtime to work evenings, weekends or holidays, as required to meet project timelines.

Experience and Skills

Required:

Bachelor’s in appropriate area of specialization with a minimum of one year of relevant work experience. Appropriate hands-on college coursework may substitute at an equivalent rate for the required experience.

Preferred:

Laboratory work experience in the fields of biotechnology, immunology, molecular biology, cell biology, or virology are required for this position.

Hands on experience with assay development and assay qualification in a cGMP compliant Quality Control laboratory for the performance of a variety of biological assays, including cell-based (viability, tissue culture, infectious titer), nucleic acid-based (restriction digests/gel electrophoresis, PCR, qPCR, DNA sequence analysis, spectrophotometric assays), protein-based (BCA, SDS-PAGE, Western, ELISA, spectrophotometric assays), and chemistry-based assays (pH, Osmolality, etc); including technical understanding of assay principles are required for this position.