Molecular Technical Transfer Specialist

Proclinical is currently recruiting for a Molecular Technical Transfer Specialist with a pharmaceutical company located in Philadelphia, PA.

Job Responsibilities:

• 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.

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