Job Description:

This position conducts tests to determine quality of raw materials, bulk intermediate, finished products, and cleaning verification/validation samples and ensure compliance with established standards. Lead method development and validation. Conducts routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples. Leads laboratory investigations and writes laboratory protocols and reports. This position may be called on to interact with clients on laboratory activities such as method development, data interpretation, investigations

· Assists 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.

· Write complex analytical development and validation protocols.

· 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 authors complex 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.

· Leads 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.

· Leads a team of analytical scientists and technicians.

· Performs other duties as assigned.

Job Skills & Qualifications:

· Bachelor’s Degree in Chemistry or relevant field with a minimum of 3 years of analytical laboratory experience.

· At least 3-5 years of experience with HPLC method development.

· Familiar with cGMPs, EU, 21 CFR Part 210, 211, and 820, ISO and ICH guidelines.

· Strong background and understanding of USP, EP, other pharmacopeia.

· Specific experience in either Dissolution testing or Aerosol testing.

· 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.

· Communicate with clients on topics such as method development, data interpretation, and investigations.

· Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios and proportions to practical solutions.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.