- Company Name
- Bayside Solutions
- Job Title
- Scientist / Associate Scientist - Peptide Formulation
- Job Description
-
Job Title: Scientist / Associate Scientist – Peptide Formulation
Role Summary: Formulation scientist responsible for the design, development, and scale‑up of solid oral and parenteral peptide formulations for early and late‑stage clinical trials, including GMP manufacturing and regulatory support.
Expectations: 8+ years of formulation experience (BS) or 5–8 years (MS) in solid oral dosage forms with expertise in peptides, biologics, or small molecules. Proven track record in pre‑clinical and clinical formulation development, GMP manufacturing oversight, and regulatory submissions (IND/IMPD/NDA).
Key Responsibilities: • Develop early‑stage solid oral dosage forms and advance to late‑stage clinical formulations. • Conduct pre‑formulation studies, formulation development, process selection, and scale‑up. • Oversee GMP drug product manufacturing and comply with global CMC regulations. • Design and execute laboratory experiments to optimize clinical formulations. • Provide formulation guidance to chemistry, biology, and discovery teams. • Utilize modern delivery technologies to enhance bioavailability of peptides/small molecules. • Generate and interpret pre‑formulation data (logP, thermal analysis, moisture content, particle size, stability). • Perform laboratory techniques (sterile technique, pH measurement, dissolution testing, lyophilization, spray drying). • Lead formulation screening studies in preclinical animal models. • Collaborate with quality control, quality assurance, and regulatory teams to resolve technical and procedural issues. • Present data and conclusions in cross‑functional meetings. • Conduct domestic or international travel for CDMO manufacturing oversight.
Required Skills: • Solid oral dosage form formulation and process development. • Peptide formulation experience (preferred). • Proficiency in analytical techniques: HPLC/MS, UV, DSC, TGA, XRPD, FTIR, DLS. • Knowledge of pharmacokinetic data generation and interpretation. • Strong organizational, critical thinking, problem‑solving, and communication skills. • Ability to work independently in a laboratory setting.
Required Education & Certifications: • 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. • Knowledge of GMP manufacturing and CMC regulatory processes (IND/IMPD/NDA).
Santa clara, United states
On site
Senior
04-02-2026