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Formulation Scientist

San Diego, CA

Order: 226267
DirectHire

Job Title: Formulation Scientist

Location: San Diego, CA

Duration: Permanent

Salary: $120-$150k+

 

We are looking for a highly motivated and passionate Formulation Scientist to join the Assay Development group focusing on developing new blood diagnostic tests. The new team member will collaborate with the team to design, execute, and interpret experiments related to formulation and stabilization of assay products for clinical chemistry, immunoassay, and hematology. The ideal candidate is independent, innovative, and a critical thinker who is well-versed in formulating and stabilizing biological materials.

  

Responsibilities:

  • Develop robust assay formulations and stabilizing process to support the deployment of a commercial product containing multiple types of diagnostic assay chemistries

  • Design & manage studies for assay lyophilization cycle development, cycle optimization, lyo process scale-up, & tech transfer

  • Perform solid state characterization of stabilized assay materials (FDM, DSC, HPLC, Karl Fischer, FTIR, CD, DLS, and sub-visible particle measurement)

  • Investigate and elucidate the mechanism of assay instability during formulation (handling and manufacturing process) and product deployment

  • Contribute formulation expertise in cross-functional product development teams

  • Research, plan, execute, analyze and document activities with superb attention to detail; keep a detailed and up-to-date laboratory notebook and present data summary in regular team meetings

  • Perform data analysis with advanced analytical and statistical tools (Prism, Excel, R)

  • Communicate results and challenges with colleagues and R&D management in a timely manner

  • Generate and maintain technical documentation for the Design History File and Device Master Records

  • Develop and validate formulation methods for product evaluation and validation

  • Prepare documents such as SOPs, forms and reports as necessary

 

Qualifications:

  • Advanced degree in Biotechnology, Chemical Engineering, Pharmaceuticals, or Chemistry with >5 years hands-on industry experience in product formulation and lyophilization or direct drying methods

  • Strong scientific background in protein lyophilization cycle development, optimization, scale up, heat transfer coefficient and cake resistance determination, lyo modeling, and tech transfer.

  • Experience in protein lyophilization and characterization technologies, including FDM, DSC, HPLC, Karl Fischer, FTIR, CD, DLS, and sub-visible particle measurement.

  • Experience with scale-up and transfer of methods to manufacturing

  • Practical experience with equipment for drying product formulations, such as lyophilization.

  • Working knowledge of IVD assay formats, including clinical chemistry, immunoassay, cell-based assay, hematology, etc.

  • Proven track record in product development and capability to be an effective R&D team member working under aggressive timelines.

  • Experience with advanced statistical data analysis tools (e.g., Prism, Excel, R) and design of experiment (DoE) strongly desired

  • Must have exceptional analytical and problem-solving skills

  • Must be organized and efficient

  • Prior experience in IVD product development a plus

  • Effective interpersonal, communication, and presentation skills

  • Superb attention to detail; produces work of exceptional quality and accuracy

  • Ability to proactively identify issues and address with solutions-oriented approach