Scientist

Essential Duties and Responsibilities

• Supports the Analytical Laboratory Services in the development and maintenance of the analytical laboratory and its practices and procedures.
• Performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods.
• Develops, conducts, and validates various chemical assays.
• Develops, evaluates, and validates analytical methods for activities such as cleaning verification via HPLC.
• Collects and analyzes routine equipment cleaning verification/validation samples.
• Complies, interprets, and documents data from analytical tests.
• Troubleshoots analytical methods and equipment.
• Prepares Certificates of Analysis and analytical reports.
• Prepares and maintains raw data for review.
• Documents analyses in laboratory notebook, worksheets, or production batch records as applicable.
• Peer-reviews laboratory records.
• Communicates quality or compliance concerns to Line Manager and Senior Management with urgency as applicable.
• Supports Out-of-Specification (OOS) or Out-of-Tolerance (OOT) laboratory investigations and communicate findings to Quality and Operations per internal SOPs.
• Supports environmental monitoring activities as required.
• Complies with Standard Operating Procedures (SOPs), cGMPs, and other regulatory standards as applicable.
• Performs other duties as assigned.

Qualifications and Experience

• Bachelor’s Degree in Chemistry or relevant field with a minimum of 2 years of analytical laboratory experience.
• At least 2 years of experience with HPLC method development.
• Familiar with cGMPs, EU, 21 CFR Part 210, 211, and 820, and ISO.
• Strong background and understanding of USP, EP, other pharmacopeia.

Competencies/Skills

• Excellent written and verbal communication skills with ability to give internal and external presentations.
• Hands-on skilled coordination and dexterity and attention to detail.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) or related software.
• Excellent organizational and communication skills.
• Read and interpret documents such as standard operating procedures, manuals, experimental protocols, and analytical methods.
• Legible Handwriting.
• Communicate clearly in writing and orally including in the creation of standard operating procedures and work instructions.
• Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios and proportions to practical solutions.

Supervisory Responsibilities: None

Schedule: 5 days a week on site, M-F

Work Environment: This job operates in an office/lab setting.

Physical Demands: Capable of lifting 50 lbs. occasionally preferred.

Travel: Travel will be required less than 10% of the time, domestic and international.