Scientist

SUMMARY/OBJECTIVE:

This position supports the R&D scientists and conducts tests to determine quality of raw materials, bulk intermediate, finished products, and cleaning verification/validation samples and ensure compliance with established standards. May perform method development and validation. Conducts routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Supports the Analytical Laboratory Services in the development and maintenance ofthe 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

SALARY:

$80,000 - $100,000

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