PLS Analytical Chemist

Analytical Chemist (Scientist I)

Pace® Life Sciences provides a full suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries from our network of CDMO sites, GMP analytical testing laboratories, and manufacturing support service centers. Our experienced, highly trained industry experts and our investment in state-of-the-art development and manufacturing facilities emphasize our commitment to efficiently advancing client programs through the clinic to commercialization. We share a common goal to bring real value to people, healthcare professionals, and health businesses around the world. Driven by our commitment to improving our health, we deliver services that offer hope and a better, safer, healthier life for everyone.  

This position would be at Pace Analytical Life Sciences in Norristown, PA. This is a full-time, 1st shift position. 

The PLS facility in Norristown focuses on preclinical, Phase 1, and Phase 2 studies of various pharmaceuticals, from new chemical entities (NCEs) to mature, marketed molecules in collaboration with a broad range of clients, from big pharma to academia to start-up biotechnology organizations. As an Analytical Chemist in the Analytical Development department, candidates will have the opportunity to work closely on cross-functional teams supporting the Pharmaceutical Development department at the facility. The incumbent will gain a thorough understanding of the early phases of the drug product development process and acquire invaluable experience in the analytical chemistry of small molecule pharmaceutical products.

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 is 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 (SOPs, cGMPs, 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 an employee must meet to perform the essential functions of the job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform 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 to 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.