Experienced GMP Analytical Chemist

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, and UPLC
• 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.

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.