Scientist II - Philadelphia, 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 Scientist II position located in Norristown, PA, Monday - Friday, from 8:00 a.m. to 5:00 p.m.

SUMMARY

Responsible for providing or overseeing the analysis, administration and oversight of comprehensive analytical chemistry policies, programs and practices; may provide feedback and guidance to clients regarding the analysis of raw materials, drug products and/or devices utilizing complex to specialized professional and technical knowledge of analytical chemistry/small molecule formulation development or related equipment, testing, and procedures. May design and develop robust analytical methods for small molecule pharmaceutical drug products for early-stage clinical trials. May interpret analytical data to guide formulation and process development decisions.

ESSENTIAL FUNCTIONS

• Develop, validate and transfer analytical methods. Provide routine and non-routine analysis using instruments such as HPLC, GC, Dissolution, among others.
• Design and develop robust analytical methods for small molecules for early-stage clinical trials.
• Ensure all activities adhere to SOP's, regulatory guidelines, GLP and GMP standards.
• Contributes to the efficiency and effectiveness of the Analytical Development department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
• Serves as a lead to staff to include providing work direction, guidance, and training.
• Overseeing or reviewing, completing, and processing comprehensive types of forms, documents, databases, related materials and information.
• Provides complex to specialized review, analysis, interpretation, and documentation of testing results. Analyzes and reviews complex to specialized operations, results, feedback, and related analytical chemistry/formulation information on an as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.
• Provides training and guidance on analytical tests, methods, and instrumentation, as required.
• Provides complex to specialized analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding analytical chemistry policies, programs, and practices; involves broad operations and leading implementation and change.
• Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/formulation information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.
• Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.

QUALIFICATIONS

Education and Experience

• Bachelor's degree in chemistry, or a closely related field.
• Three to five (3-5) years of experience, including experience with early phase small molecule pharmaceutical product development, specialized or technical programs or operations; OR an equivalent combination of education, training, and experience. Master's or PhD degree is strongly preferred.

Required Knowledge and Skills

Required Knowledge

• Complex to specialized principles, practices, and techniques related to an analytical development laboratory supporting early phase small molecule pharmaceutical product development.
• Broad understanding of the administration and oversight of analytical chemistry laboratory programs, policies, and procedures.
• Broad understanding of GMP/FDA/ICH regulations related analytical testing of small molecule pharmaceuticals.
• Understanding of broad testing analytical instrumentation, equipment, and calibration.
• Computer applications and systems related to the work (chromatography data systems, LIMS, etc.).
• Principles and practices needed to serve as an effective project team member.
• Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
• Correct business English, including spelling, grammar, and punctuation.

Required Skills

• Performing complex to specialized professional-level analytical chemistry functions in a variety of project applications.
• Interpreting, applying, and explaining applicable laws, codes, and regulations (GMP, FDA, ICH).
• Overseeing and administering broad and varied analytical chemistry/formulation functions.
• Ability to operate and train others in analytical instruments and manufacturing equipment.
• Training others in policies and procedures related to the work.
• Serving as a team member and the development and management of projects.
• Operating in both a team and individual contributor environment.
• Preparing advanced to expert functionals reports, correspondence, and other written materials.
• Using initiative and independent judgment within established department guidelines.
• Using tact, discretion, and prudence in working with those contacted during the work.
• Performing effective oral presentations to large and small groups across functional peers and the department.
• Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.
• Establishing and maintaining effective working relationships with various individuals contacted in the work.

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.