Proclinical is currently recruiting for a Scientist for a global pharmaceutical company located in Philadelphia, PA. Successful candidate must demonstrate innovative technical knowledge and significantly contribute to the overall operations of the Virology lab.
- Oversee the transfer of custom studies from the Technical Team to Operations.
- Lead training on custom methods and mentor operational staff.
- Utilize technical expertise in virology and cell culture processes to improve upon existing assays/methods.
- Possess strong oral and written communication skills and actively contributes to report generation and documentation.
- Perform and direct assays according to, and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Act as Study Director/technical reviewer as required.
- Conduct critical review of results and reports data to appropriate internal staff.
- Coordinate with internal departments to assure that appropriate testing information is effectively communicated and documented.
- Prepare and revise technical documents.
- As assigned by Management, act as Study Director or Principal Investigator for assigned assays and assume all associated responsibilities.
- Conduct and direct assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
- Assure batch records and other paperwork is completed according to GLPs / cGMPs and company SOPs.
- Review/write Final Reports for protocols assigned and participates in critical review and interpretation of test results.
- Work on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
- Normally receives minimal instructions on routine work and detailed instructions on new assignments.
- Work under close supervision from supervisor or senior personnel.
Skills and Requirements:
- PhD with minimum 2-4 years of experience or MS with minimum of 4-6 years of experience or BS with 6-8 years of relevant laboratory experience in pharmaceutical or biotechnology industry.
- Ability to work in a team environment and independently as required.
- Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.
- Comprehensive virus, cell culture, ELISA and RT qPCR experience.
- Experience with Lenti, Adenovirus and AAV viral vectors.
- Client Facing, project management, CRO and CMO experience preferred.
- Experience in the Gene Therapy field preferred.
- Experience with assay qualification and assay validation a plus.
- Possess thorough knowledge of analytical and protein-based assays.
- Knowledge of GLP and cGMP preferred.
- Ability to record data following Good Documentation Practices.
- Effective multi-tasking skills and time management required.
- Proficient in Oral & Written communication skills.
- Need to be able to read, write and understand English.
- Proficient in Microsoft (Excel, Word, Outlook).
- Must be able to work in an office environment with minimal noise conditions.
- Must be able to work in Lab setting with Biohazards /various Chemicals
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mike Raletz at (+1) 267-428-7770 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.