Scientist , Formulation Development

Overview

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.

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

• A four‑year college degree in a technically related field (e.g., biology, chemistry, chemical engineering, biochemistry, pharmaceutical sciences, etc.).
• At least 3 years of hands‑on laboratory experience in academia and/or industry. This does not include laboratory coursework but can include time spent performing dedicated research toward a graduate degree.
• Able to learn complex tasks with general instruction and perform them independently, efficiently and reliably.
• Able to prepare protocols, reports and presentations and maintain accurate and detailed records of work performed.
• Previous experience in a quality control or other regulated (FDA, EPA, etc.) testing laboratory is a plus.
• Working knowledge of Microsoft Productivity software (Excel, Word, PowerPoint, etc.).
• Basic knowledge and proficiency using experimental design software (e.g., JMP / Minitab) and statistical analysis software (e.g., Graph Pad Prism) is a plus.
• Competencies:
  
  Attention to Detail, Independent Judgement, Teamwork & Collaboration, Self‑Starter, Adaptability, Professionalism, and Written & Verbal Communication skills.
• Working Conditions:
  
  Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Must be able to stand for extended periods of time. Must be able to lift 25 lbs. or more. Adequate vision (corrected or uncorrected) to read fine instruments such as calipers, instrument displays etc. and perform visual inspection for defects. This role is based in Xeris’ Chicago office…