Job Specifications
Scientist / Associate Scientist - Peptide Formulation
W2 Contract
Salary Range: $114,400 - $135,200 per year
Location: Newark, CA - Onsite Role
Job Summary:
We are seeking a highly motivated formulation scientist to support our clinical programs. The ideal candidate will have experience designing and developing early-stage clinical formulations and process development across multiple delivery routes, particularly oral and parenteral. Peptide experience is preferred, though relevant biologics or small molecule formulation experience will also be considered. This role requires independent laboratory work, cross-functional collaboration, and knowledge of preclinical and clinical formulation preparation.
Duties and Responsibilities:
Develop solid oral dosage forms for early- and late-stage clinical trials.
Conduct pre-formulation, formulation development, process selection, and scale-up.
Oversee GMP drug product manufacturing and comply with global regulatory CMC requirements (INDs, IMPDs, NDAs).
Design and execute laboratory experiments to optimize clinical formulations.
Provide formulation guidance to chemistry and biology teams to integrate formulation early into the discovery process.
Utilize modern delivery technologies to enhance the bioavailability of small molecules or peptides.
Generate and interpret pre-formulation data (e.g., logP, thermal analysis, moisture content, particle size, stability).
Apply laboratory techniques such as sterile technique, pH measurement, dissolution testing, lyophilization, and spray drying.
Oversee formulation screening studies in preclinical animal models.
Collaborate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical or procedural issues.
Represent pharmaceutical sciences in cross-functional meetings and present data and conclusions.
Travel domestically or internationally as needed for manufacturing oversight at CDMOs.
Requirements and Qualifications:
Hands-on experience in solid oral dosage form formulation and process development.
Knowledge of gastrointestinal site-specific drug delivery is a plus.
Proficient with analytical techniques such as HPLC/MS, UV, DSC, TGA, XRPD, FTIR, and DLS.
Understanding of pharmacokinetic data generation and interpretation.
Strong organizational, critical thinking, and problem-solving skills.
Excellent written and verbal communication skills.
BS in Chemistry, Pharmaceutics, Engineering, or related scientific discipline with 8+ years of formulation experience
MS in a related field with 5-8 years of experience
Desired Skills and Experience
Peptide formulation, solid oral dosage form development, parenteral formulation development, early- and late-stage clinical formulation, pre-formulation studies, formulation development, process development, process selection, scale-up, GMP drug product manufacturing, CMC regulatory support, IND/IMPD/NDA support, clinical formulation preparation, laboratory experiment design and execution, bioavailability enhancement, drug delivery technologies, small molecule formulation, biologics formulation, gastrointestinal site-specific drug delivery, pharmacokinetics data interpretation, formulation screening in preclinical models, analytical method utilization, HPLC/MS, UV spectroscopy, DSC, TGA, XRPD, FTIR, DLS, dissolution testing, lyophilization, spray drying, sterile technique, pH measurement, particle size analysis, stability studies, thermal analysis, moisture content analysis, cross-functional collaboration, formulation support to chemistry and biology teams, quality control collaboration, quality assurance collaboration, regulatory collaboration, CDMO manufacturing oversight, technical issue resolution, data presentation, scientific communication, independent laboratory work, problem solving, critical thinking, organizational skills
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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