Analytical Chemist

Analytical Chemist (Associate Scientist II/Scientist I)

Pace Analytical Life Sciences (PLS) is an industry leading contract lab supplying, formulation development, clinical trial manufacturing and analytical chemistry services to the Pharmaceutical, and Life Sciences industry.

This position would be at Pace Analytical Life Sciences in Norristown, PA. This is a full-time, 2nd shift position.

Summary:

Employees are exposed to a varied and challenging range of product development projects in a dynamic, fast-paced, rewarding, work environment, with state of the art equipment.

Primary Responsibilities:

• Support small molecule drug development through HPLC and GC based analysis of drug product prototypes, QC release samples, and stability samples.
• Perform testing including assay/related substances, content uniformity, dissolution, Karl Fischer titration, and residual solvents
• Write/review test methods, analytical reports, and SOPs according to applicable regulatory and/or company guidelines.
• Support maintenance, calibration, and qualification of instruments and equipment as needed.
• Support out of specification (OOS) and deviation investigations and resolution.
• Participate as a key or lead member of a project team, presenting data in group and department meetings.

Desired Skills:

• BS degree in Chemistry or related field required;
• A minimum of 3 years’ experience performing cGMP pharmaceutical analysis strongly preferred
• Experience with HPLC analysis for small molecules
• Proficiency in wet-chemistry along with knowledge of GMP and Regulatory Requirements (FDA, USP, ICH, etc.)
• Working knowledge of Empower software is strongly preferred
• Knowledge of various regulatory systems and guidelines (SOP's, cGMP's, IPEC, ICH requirements, stability and validation)
• Self-starter with the proven ability to work in a team environment as well as independently while handling multiple projects
• Proven ability to communicate with customers/clients in both oral and written form; fluent in the English language
• Willingness to learn and expand their knowledge and technical expertise in a fast paced environment.
• Strong computer skills; emphasis on Microsoft Excel and Word

Physical/Mental Requirements:

The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.

Working Environment:

Work is performed in a lab and office setting. Work is subject chemicals, fumes, gasses, noxious odors and related items in a lab setting.

OFCCP Statement

Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity