Bayside Solutions · 14 hours ago
Scientist / Associate Scientist - Peptide Formulation
Bayside Solutions is seeking a highly motivated formulation scientist to support their clinical programs. The ideal candidate will have experience in designing and developing early-stage clinical formulations and will be responsible for overseeing GMP drug product manufacturing and collaborating across teams to integrate formulation early into the discovery process.
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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
Qualification
Required
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
Preferred
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
Pharmacokinetics data interpretation
Formulation screening in preclinical models
Analytical method utilization
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