Molecular Technical Transfer Specialist
Proclinical is currently recruiting for a Molecular Technical Transfer Specialist with a pharmaceutical company located in Philadelphia, PA.
- Independently perform routine assays and generate high quality data.
- Demonstrate innovative and independent scientific technical expertise and proficiency in scientific theory and rigorous practical application in the completion of laboratory procedures
- Guide R&D, validation, and/or qualification activities of client materials in accordance to regulatory guidelines
- Aid in the transfer of projects from R&D, validation, and/or qualification into routine operations
- Interact with clients to address scientific and project-related requirements
- Effectively communicate and defend science through written and verbal communication
- Implement innovative solutions and propose new technologies in support of multiple projects
- Provide guidance to clients about the requirements needed for regulatory filings
- Conduct critical review of results and report data to appropriate internal staff
- Coordinate with internal departments (i.e. Quality Assurance, Client Services, etc.) to assure that appropriate testing information is effectively communicated and documented
- Aid Account Managers with sales opportunities
- Help determine departmental capacity to ensure programs can be completed by established timelines
- Prepare and revise technical documents (Laboratory protocols, SOPs, etc.) and laboratory reports
- Ensure batch records and other paperwork is completed according to Good Documentation Practices and our internal SOPs
- Provide insights during audits and regulatory agencies
- Write and review nonconformances and laboratory investigations
- Works under minimal supervision from supervisor or senior personnel.
- Ability to work in a team environment and independently as required
- Contribute to the overall operations and to the achievement of departmental goals
- Perform job specific tasks in compliance with applicable Regulations, International Standards, and our Policies and Standard Operating Procedures.
Skills and Requirements:
- Bachelor's degree with a major in Biological Sciences or other science related major with 4 years' or more experience
- Experience with virus production and cell culture, or
- Experience with Molecular based methods such as PCR, sequencing, and Primer and Probe design, or
- Experience with Analytical methods such as ELISA and HPLC
- Experience with Lenti, Adenovirus and AAV viral vectors
- CRO and CMO experience preferred
- Experience with assay qualification and assay validation according to ICH parameters is a plus
- Knowledge of GLP and cGMP guidelines is preferred.
- Ability to use judgment as dictated by complexity of situation.
- Ability to work under limited supervision and to handle problems of a more difficult nature.
- Ability to accomplish the described duties through the use of appropriate laboratory equipment (i.e. biohazard hood, centrifuge, incubator, etc) .
- Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
- Ability to trouble shoot and solve technical problems
- Proficient in Oral & Written communication skills
- Proficient in Microsoft (Excel, Word, Outlook)
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.
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.