Principal Scientist - Norristown, PA

Pace Life Sciences

Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations.

This is a full-time Senior Scientist/Principal Scientist position located in Norristown, PA, Monday - Friday, from 8:00 a.m. to 5:00 p.m.

SUMMARY

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

The PLS facility in Norristown focuses on developing solid oral dosage forms of small molecule drug substances for preclinical, Phase 1 and Phase 2 drug development programs. The site develops and analyzes formulations for a variety of drug substances from new chemical entities (NCE's) to mature, marketed molecules in collaboration with a broad range of clients, from big pharma to start-ups, virtual organizations, and academia.

As a Senior Scientist/Principal Scientist in the Analytical Development department, candidates will have the opportunity to work closely on cross-functional teams primarily focused on supporting the Pharmaceutical Development department at the facility. The candidate will provide their expertise and thorough understanding of the application of analytical chemistry techniques related to the analysis of small molecule pharmaceutical products to development of early phase drug products.

Primary Responsibilities:

• Support preclinical through clinical phase small molecule pharmaceutical development activities by contributing to a team focused on instrumental analysis (UPLC/HPLC, GC, USP Dissolution, XRD, DSC, SEM, etc.) of preliminary drug product prototypes through to GMP release and stability samples.
• Serve as a technical subject matter expert in analytical chemistry, providing research, expert analysis and interpretation of data as well as counsel and training to staff, management, site leadership, and external clients regarding analyte molecules and their chemistry, analytical methods and instrumentation.
• Perform and coordinate complex R&D and GMP experimental studies, method development and validation experiments in support of methods for assay, related substances, content uniformity, dissolution, water content by Karl Fischer titration, residual solvents, and other tests of critical quality attributes.
• Participate as a key or lead member of a project team, participating in meetings by presenting data and other feedback to internal and external (client) team members.
• Serve as a technical leader to staff providing work direction, guidance, and training.
• Write/review test methods, analytical protocols, reports, and SOPs according to applicable regulatory and/or company guidelines.
• Author out of specification (OOS) and deviation investigations and contribute to their resolution.
• Support maintenance, calibration, and qualification of instruments and equipment as needed.

QUALIFICATIONS

Education and Experience

• Minimum of ten (10) years of experience, including experience with early phase small molecule pharmaceutical product development, specialized or technical programs or operations; PhD degree is strongly preferred, but an equivalent combination of education, training, and experience may be considered.

Required Knowledge and Skills

• Proficient and thorough understanding of principles, practices, and techniques related to an analytical development laboratory supporting early phase small molecule pharmaceutical product development.
• Proficiency in analytical chemistry laboratory techniques related to small molecule pharmaceutical products, along with knowledge of relevant CGMP and regulatory requirements and guidelines (FDA, USP, ICH, etc)
• Extensive experience with HPLC/UPLC analysis of small molecule pharmaceuticals.
• Self-starter with the proven ability to work in a team environment as well as independently while handling multiple projects
• Willingness to learn and expand their knowledge and technical expertise in a dynamic working environment.
• Proven ability to clearly communicate with coworkers, customers/clients in both oral and written form; fluency in English and use of business English, including proper spelling, grammar, and punctuation. Able to deliver oral presentations to large and small groups across departments and companies.
• Proficiency in use of MS Office tools (primarily Excel and Word), working knowledge of Empower chromatography software is strongly preferred. Ability and willingness to learn and master a variety of software platforms is required.
• Ability to take initiative and use independent judgment within established department guidelines.
• Ability to use tact, discretion, and prudence in working with those contacted during the work.
• Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.
• Establishing and maintaining effective working relationships with various individuals in the workplace and remotely.

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 to chemicals, fumes, gasses, noxious odors, and related items in a lab setting.