SUMMARY

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

 

ESSENTIAL FUNCTIONS 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, and related materials and information. Provides specialized to advanced analysis in support of various testing materials, products and/or devices utilizing various analytical instrumentation; follows Standard Operating Procedures and methods to perform testing. Provides specialized to advanced review, analysis, interpretation, and documentation of testing results. Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/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 specialized to advanced analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change. Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/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. Assists with developing or participating in chemistry/biochemistry/formulation or cross functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management and/or clients. Develop validate and transfer analytical methods. Provide routine and non-routine analysis using instruments such as HPLC, GC, LC-MS, and FTIR, among others. Design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products. Ensure all activities adhere to SOP's, regulatory guidelines, GLP and GMP standards. Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team. 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/biochemistry, or a closely related field Seven to ten (7-10) years of experience, including experience with specialized or technical programs or operations; project management, customer facing OR an equivalent combination of education, training, and experience. Master's degree preferred Required Knowledge and Skills Required Knowledge Specialized to advanced principles, practices, and techniques of chemistry/biochemistry and formulation development. Broad understanding of the administration and oversight of chemistry/biochemistry programs, policies, and procedures. Specialized to advanced methods to resolve chemistry/biochemistry problems, questions, and concerns. Broad understanding of applicable chemistry/biochemistry laws, codes, and regulations. Understanding of broad testing tools, equipment, and calibration. Computer applications and systems related to the work. Principles and practices to serving 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 specialized to advanced professional-level chemistry/biochemistry duties in a variety of assigned areas. Overseeing and administering broad and varied chemistry/biochemistry/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 a both a team and individual contributor environment. Interpreting, applying, and explaining applicable laws, codes, and regulations. Preparing specialized to advanced 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 in the course of 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 a variety of individuals contacted in the course of the work.