Formulation Scientist

Industry: Biotech

Job Type: Contract - remote with some travel to site in NJ or PA

Position Summary:

A leading pharmaceutical/biotechnology company is seeking a highly motivated and detail-oriented Pediatric Formulation Scientist to join their Research & Development team. This role focuses on developing innovative, patient-centric small molecule formulations tailored specifically for pediatric populations, spanning preclinical through commercial stages. The ideal candidate will combine strong technical formulation skills with a passion for improving pediatric drug delivery—making medicines safer, tastier, and easier for kids to take.

Key Responsibilities:

Formulation Development:

• Design and develop age-appropriate oral, parenteral, and alternative dosage forms (e.g., suspensions, granules, chewables, mini-tablets) for pediatric use.
• Address key pediatric formulation challenges including taste masking, dose flexibility, excipient safety, and ease of administration.

Preformulation and Compatibility Studies:

• Perform comprehensive preformulation characterization of active pharmaceutical ingredients (APIs).
• Assess excipient compatibility, stability risks, and manufacturability to inform formulation design.

Process Development:

• Translate laboratory-scale formulations into scalable processes for clinical and commercial manufacturing.
• Support technology transfer activities to contract manufacturing organizations (CMOs) or internal production teams.

Regulatory and Compliance:

• Author formulation development reports, Chemistry, Manufacturing, and Controls (CMC) documentation, and regulatory briefing materials in alignment with FDA, EMA, and ICH pediatric guidelines.
• Ensure compliance with current Good Manufacturing Practices (cGMP) and Quality by Design (QbD) principles.

Cross-Functional Collaboration:

• Partner closely with Analytical Development, Clinical Pharmacology, Regulatory Affairs, and Clinical Operations teams to ensure alignment of formulation strategies with overall program goals.
• Provide formulation expertise to support pediatric study designs, including pharmacokinetic bridging studies and age-group stratification plans.

Problem Solving:

• Proactively identify, troubleshoot, and resolve formulation, stability, and manufacturability challenges to ensure successful program execution.

Qualifications:

• Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or a related discipline with 0–3 years of relevant experience, or
• M.S. degree with 4–7 years of hands-on experience in pediatric or small molecule formulation development.

Required Technical Expertise:

• Deep knowledge of pediatric formulation principles, with a strong understanding of excipient safety and regulatory requirements (e.g., FDA/EMA excipient guidelines for pediatrics).
• Practical experience developing various pediatric dosage forms, including solutions, suspensions, orally disintegrating tablets (ODTs), and mini-tablets.
• Familiarity with taste-masking technologies (e.g., coatings, ion-exchange resins, flavor profiling).

Additional Desired Skills:

• Experience supporting regulatory submissions (IND, IMPD, NDA, MAA).
• Working knowledge of biopharmaceutics concepts such as BCS classification, dissolution, and permeability.
• Exposure to stability testing in accordance with ICH guidelines.