Molecular Technical Transfer Specialist

Highly Competitive Salary
  1. Permanent
  2. Biochemistry, Biological Sciences, Laboratory Technician
  3. United States
Philadelphia, USA
Posting date: 22 Sep 2020

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.