About this role
Shift: Monday - Friday, 8:30 AM - 5:00 PM Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives. 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 This class specification lists the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform job-related duties other than those contained in this document and may be required to have specific job-related knowledge and skills. • Serves as a lead to staff to include providing work direction, guidance, and training. • Designs experimental procedures to define objectives and execution of studies based on industry guidelines. • Leads research and development projects, tracks progress to ensure on-time completion, within budget, and high-quality results. • Provides advanced to expert 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 advanced to expert 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 training and guidance on analytical tests, methods, and instrumentation, as required. • Provides advanced to expert 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 To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Education and Experience Bachelor's degree in chemistry/biochemistry, or a closely related field; AND at least (8) years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience.
A Master's or Ph.D. degree is strongly preferred. Required Certificates, Licenses, and Registrations Continued employment is contingent upon all required licenses and certificates being maintained in active status without suspension or revocation. • None. Required Knowledge and Skills Required Knowledge • Advanced to expert principles, practices, and techniques of chemistry/biochemistry and formulation development/ • Broad understanding of the administration and oversight of chemistry/biochemistry programs, policies, and procedures. • Advanced to expert 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 advanced to expert 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, and innovative practices related to the work. • Serving as a leader in the design, development, and management of projects. • Operating in both a team and individual contributor environment, as well as project leader. • Interpreting, applying, and explaining applicable laws, codes, and regulations. • 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 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. 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, gases, noxious odors, and related items in a lab setting.
Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work. Benefits When you join Pace®, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life.
Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft. Equal Opportunity Employer Pace® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.