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SR - Analytical Chemist
at Tunnell Consulting
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Greater Philadelphia Area
US - Pennsylvania
Client Project Number:
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.
- 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
- 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