Scientist I, Formulation Development

This role will assist more senior Formulation Scientists to develop stable therapeutic pharmaceutical formulations. This position will work under general supervision as needed to support technical assignments. At times, may train or provide guidance to less experienced staff. This role will be responsible for maintaining a clean, organized laboratory and ensuring that instruments are calibrated and functioning properly. The Scientist I, Formulation Development will proactively monitor ongoing studies and tasks to propose alternatives or solutions in response to unanticipated data and results.

• Configures and operates laboratory instruments as needed to perform experimental studies.
• Prepares and characterizes test articles and certificates-of-testing to support non-clinical studies.
• Analyzes, compiles, and interprets the results of sample characterization tests (. e.g., UHPLC, etc.).
• Mentors and trains new laboratory personnel and interns.
• Maintains an updated inventory of chemicals, reagents and other laboratory supplies.
• Demonstrates a firm understanding of relevant technical/scientific literature, standard procedures, and pharmaceutical regulations relevant to the programs.
• Participates in laboratory meetings and planning sessions and preparing relevant materials (agendas, reports, presentations).
• Applies routine statistical tools to analyze and interpret data/results and identify relevant trends. Has awareness of more complex statistical tools (eg, DOE, ANOVA, etc) and actively works towards increased understanding.
• Assists with planning, and then executes routine and nonroutine laboratory experiments and technical assignments.
• Accurately collects data and appropriately records observations
• Interacts and coordinates with instrument manufacturers / vendors when repairs and maintenance are required.
• Maintains an organized and updated laboratory notebook per company policy.
• Develops and implements solutions to technical challenges of moderate scope and complexity.
• Prepares Standard Operating Procedures (SOP’s) for basic operation of laboratory equipment (balances, stability chambers etc.).
• Reads and interprets compendial monographs and procedures (USP/NF).
• Plans, designs, and executes designed experiments for optimizing formulation stability.
• Orders supplies, obtaining quotes, and preparing Purchase Orders for the Product Development department.
• Writes and reviews study protocols and reports (both formal and informal) to support product development studies and regulatory filings.
• Performs the duties of a Laboratory Manager (e.g., cleaning and organizing the lab) as required.

• This does not include laboratory course work but can include time spent performing dedicated research toward a graduate degree.
• A four-year college degree in a scientifically related field (e.g. biology, chemistry, biochemistry, pharmaceutical sciences, etc.).
• Working knowledge of Microsoft Productivity software (Excel, Word, PowerPoint etc.).
• Competencies Attention to Detail, Independent Judgement, Teamwork & Collaboration, Self-Starter, Adaptability, Professionalism, Written & Verbal Communication skills.
• Previous experience in a quality control or other regulated (FDA, EPA etc.) testing laboratory a plus.
• Able to prepare protocols, reports and presentations and maintain accurate and detailed records of work performed.
• Able to learn complex tasks with general instruction and perform them independently, efficiently and reliably.
• Basic knowledge and proficiency using experimental design software (e.g., JMP / MiniTab).
• At least 3 years of hands-on laboratory experience in academia and/or industry

Working Conditions

• Must be able to stand for extended periods of time. Must be able to lift 25 lbs. or more.
• Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
• Adequate vision (corrected or uncorrected) to read fine instruments such as caliper, instrument displays etc. and perform visual inspection for defects.