Analytical Scientist- Purification And Chromatography

Analytical Scientist- Purification And Chromatography

Location

Stony Brook, New York

Employment Type

Permanent

Industry

Medical Device & Biotech

Job ID

9199


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Our client is focused on large scale linear DNA production for diagnostics and vaccines.


Job Description:

Analytical Scientist- Purification & Chromatography

Our client is seeking a pro-active and methodical scientist, dedicated to providing exceptional post-processing product to GMP quality standards and customer requirements, as well as routine and investigative analysis of DNA product. The Analytical Scientist provides expertise in support of Manufacturing, Product Development, and Quality Compliance. Candidates will have experience in developing, validating, and transferring of manufacturing methods to quality control for testing with collaborative focus on customer and industry requirements.

Duties and Responsibilities:  

  • Utilize chromatography (i.e. LC, IC, and GC), UV-Vis, dissolution, and other associated analytical techniques.
  • Experience with Cytiva platform using Unicorn software (revision 7.0 preferred) for purification of PCR-produced DNA product highly desired
  • Support the development of new products and resolve customer concerns; Interact closely with R&D, Technical Support & development and QC teams.
  • Provide support to manufacturing and quality associates in resolving production process issues and provide methodology.
  • Maintain a laboratory notebook, provide insightful analysis reports; prepare monthly project reports and utilize database.
  • Provide technical direction within own area of expertise (GC) within the team while independently performing a range of GMP analyses by GC including method development / optimization and validation.
  • Always provide high quality customer service by ensuring effective organization of assigned workload, integrity of analytical data and timely/accurate provision of results.
  • Liaise with business development and management to ensure effective communication and operations plan for project proposals and results.
  • Write and approve SOPs and test methods.
  • Take responsibility for specific project management and/or specific areas of general laboratory/sample administration and assignment of housekeeping tasks as required.
  • Work to the highest standards of safety and quality by ensuring that appropriate COSHHs, risk assessments and SOPs are understood and followed.

 



Job Requirements:

Qualifications:

  • Bachelor's, Master’s or PhD with corresponding years of experience in chromatography, dissolution, pre-formulation, postproduction, and analytical development.
  • Minimum of 8 years (BS), 5 years (MS), or 3 years (PhD) of related laboratory work experience (HPLC, UPLC, UV-VIS, IC, Dissolution) in a pharmaceutical or biopharma environment.
  • Significant operational experience with all chromatographic analytical instrumentation (GPC, LC, LC/MS, GC, GC/MS) applied in an industrial setting.
  • Demonstrated ability in chemical/physical procedures for isolation of impurities, optimal instrument configuration for the specific chemical matrix and the application of statistical data analysis methods are required.
  • The chromatography instrumentation the candidate will be responsible for using and maintaining includes Cytiva platform with Unicorn software (rev 7.0 preferred), Agilent GC’s and GC/MS, Agilent LC’s, Agilent Q-TOF, Wyatt GPC/MALS, and Dionex IC. Chromatography software includes Agilent Chemstation and Mass Hunter, Perkin Elmer Total Chrom, and Wyatt Astra.
  • Significant research record in Chromatography and demonstrated history of chromatographic method development using a variety of isolation/concentration techniques.
  • Experience specifically in small molecule, surfactant and polymer analysis is desirable.
  • Critical thinking, problem solving and troubleshooting capabilities.
  • Experience with design and troubleshooting experiments and interpretation of data.
  • As a strategic thinker with the ability to anticipate future problems you like to drive change.
  • Experience with current Good Manufacturing Practices (cGMP)                                          

 

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Contact Details:

Scott Passeser, Sr. VP

Executive Alliance

Commack, NY 11725

scott@execsallied.com