Tunnell Consulting

Receive alerts when this company posts new jobs.

Similar Jobs

Job Details

SR - Analytical Chemist

at Tunnell Consulting

Posted: 3/9/2019
Job Reference #: 9180

Job Description

 If you are not sure if you already have a profile in our system, please click on the "Forgot Password" Link below. Our system recognizes previous applicants by the applicant' email address.

Please Note: If you submit your application with an existing email address, you will be notified once you click on submit and you will have to resubmit your application. 

Job City:
Greater Philadelphia Area

Job State:
US - Pennsylvania

Client Project Number:
9180

The client is looking for an energetic and talented individual to join their Tech Transfer team. The
candidate will independently transfer bio-analytical methods typically used to characterize vaccine drug substance and drug products (including but not limited to: ELISA, different modes of chromatography, spectrometry such as MS and NMR, CE, colorimetric and light-
scattering technique ) from a development site to a commercial manufacturing site.  The successful candidate will also provide scientific
mentorship and technical guidance to junior colleagues working on bio-analytical method transfer.  The successful candidate will review analytical data, author protocols and reports, coordinate and oversee the assay transfer.

Essential Functions:

  • Independently lead the transfer of analytical methods for purity, content, and other quality attributes of biologic drug substances, carbohydrates, vaccine targets and drug product.
  • Perform appropriate CRO/CMO oversight by reviewing analytical method development data, reviewing and approving analytical method validation protocols and subsequent reports, and reviewing and approving analytical method SOPs
  • Provide technical oversight to drug substance/drug product release and stability testing, as well as trouble shooting and analytical investigation at CRO/CMOs
  • Author protocols, reports, and regulatory submissions as appropriate


Requirements:

  • PhD or Masters Degree in Bio-Chemistry, Molecular Biology or Microbiology with 8+ years of industry experience.  Those requirements can be lessened for candidates that have significant relevant work experience.  
  • Expertise in Bio-Assay transfers.
  • Knowledge of vaccine manufacturing and chemistry preferred.
  • Ideal candidate will have a strong theoretical understanding of various analytical chemistry methodology principles and successful track record of method development trouble shooting and validation.
  • Extensive hands-on experience with modern analytical instrumentations commonly used in the analysis and characterization of vaccines, biologics, carbohydrates and conjugates.
  • Experience working in a regulated (GLP / GMP) environment
  • Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to analytical method development and qualification/validation for biologics and vaccines, and demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical strategy
  • Attention to detail and excellent skills in record keeping / documentation
  • Extensive technical writing experience in drafting method protocols, SOPs and reports
  • Project management skills including the ability to manage one’s project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
  • Strong interpersonal skills; ability to communicate effectively both verbally and in written formats
  • Self-starter; ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members