Associate Scientist III – Finished Products
Pace Analytical Life Sciences (PLS) is an industry leading contract lab supplying analytical chemistry and microbiology services to the Medical Device, Pharmaceutical, and Life Sciences industry. Since our formation in 2006 we have grown at a rate of over 10% per year and established ourselves as one of the top ten contract laboratories within the United States providing cGMP services to a wide range of clients worldwide. We attribute our rapid growth to our solid quality system combined with an exceptional culture of client service.
We are actively seeking highly skilled candidates with strong analytical chemistry experience who are interested in a lab position that would support the development, validation, and transfer of methods for analysis of active pharmaceutical ingredients (APIs) and pharmaceutical finished products. The ideal candidate is one who will thrive working in a highly dynamic, team oriented environment; sharing the common goal of providing reliable data to our clients that can be used to improve the safety and effectiveness of pharmaceutical products.
Candidates should have prior analytical experience with various wet chemistry techniques, HPLC, GS, Dissolution, and UV-VIS preferred candidate has experience with and Waters Empower Software and be able to demonstrate their interest in continuing to acquire new analytical knowledge and skills. Additionally, a four year degree in a physical science field, such as chemistry, is required. Experience in cGMP & GDP environment preferred. Experience with the United States Pharmacopeia and the European Pharmacopeia is preferred.
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.
- Provides complex to specialized analysis in support of standard testing materials and products utilizing standard analytical instrumentation; follows standard operating procedures and methods to perform testing.
- Provides complex to specialized review, analysis, interpretation, and documentation of testing results.
- Overseeing or reviewing, completing, and processing a comprehensive range of standard analysis forms, documents, databases, and related materials and information.
- Provides training and guidance to analytical tests, methods and instrumentation, as required.
- Provides complex to specialized analysis and interpretation/counsel to staff, management, and functional leaders regarding the chemistry/biochemistry policies, programs and practices; involves standard operations.
- Provides broad research, feedback and decisions to resolve management and employee questions and requirements; assists with receiving customer feedback and coordinating resources and responses as required.
- Analyzes and reviews very complex to specialized operations, results, feedback and related scientific information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals and recommendations to management.
- Ensures the accuracy of broad tests, equipment, actions, procedures and operational databases, reports and related details through audits, queries, and operational reviews; resolves discrepancies or escalates discrepancies to ensure quality assurance in testing.
- Assists with developing or participating in Biopharmaceutical Services or cross-functional project or program objectives, which includes timelines, materials, personnel, and other project requirements, receives direction and presents information to management.
- Cleans, maintains, prepares and calibrates equipment, samples, and related areas.
- 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 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.
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, materials science, or physics or a closely related field; AND at least five (5) years of experience, including experience with specialized or technical programs or operations; OR equivalent combination of education, training and experience.
- Five years or more experience with HPLC, GC, and UV-VIS, and Waters Empower software
- cGMP experience preferred
- Demonstrated ability to work independently
- Ideal candidate is self guided, motivated, and possesses a strong sense of initiative
Required Knowledge and Skills
- Very complex to specialized principles, practices, and techniques in the field of chemistry/biochemistry.
- Broad understanding of the administration and oversight of area programs, policies, and procedures.
- Very complex to specialized methods to resolve chemistry/biochemistry problems, questions, and concerns.
- Broad understanding of several key testing tools, equipment, and calibration including HPLC
- Computer applications and systems related to the work.
- Principles and practices 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.
- Ability to perform very complex to specialized professional-level lab work in a high paced environment.
- Oversee and administer standard functions in the Biopharmaceutical Services group.
- Training others in policies and procedures.
- 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 fundamental functional 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.
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.
Work is performed in a lab and office setting. Work is subject chemicals, fumes, gasses, noxious odors and related items in a lab setting.
Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.
This is a 40 hour a week position. Working Monday through Friday between the hours of 8:00am and 5:00pm