Molecular Technical Transfer Specialist job in Philadelphia, USA

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Job type: Permanent

Discipline: Biochemistry, Biological Sciences, Laboratory Technician

Location: United States

This vacancy has now expired. Please see similar roles below...

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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