Vacancy expired!
Research Associate II - Intermediate LevelJOB DESCRIPTIONThe Method Development and Analytical Services (MDAS) Research Associate II is an experienced resource in performing sample testing and validating the methods necessary to support development and commercialization of pharmaceutical products. The MDAS Research Associate II is responsible for performing the bench chemistry testing of pharmaceutical products supporting development of new products, incoming transfer of existing products, and analytical support of product life cycle management. The MDAS Research Associate II will assist in performing method development, transfer, validation, and/or verification for methods related to analyzing raw materials, semi-finished/finished products, and stability. Customer communication and active participation as the analytical chemistry expert on work teams may be required.ORGANIZATION STRUCTUREThe Research Associate II typically reports to a Group Supervisor/Leader, Manager or Director. The Research Associate II may guide the activities of junior staff.RESPONSIBILITIES Performs hands-on laboratory bench work and sample testing supporting development of pharmaceutical products. This includes but is not limited to performing assay, related compounds testing, dissolution, uniformity, and other tests to characterize and demonstrate product performance. Perform laboratory bench work to develop, optimize, and troubleshoot analytical methods for testing raw materials and products (semi-finished and finished). Validate analytical methods necessary for commercialization of pharmaceutical products. This includes evaluating validation/verification/transfer requirements, equipment acquisition/installation, reference standards/reagents, drafting protocols, methods/reports, training, specification development, and other steps as required. Authoring and reviewing method validation/verification/transfer protocols and reports compliant with cGMP regulations, industry standards, and customer direction and consistent with the developed installation strategy and project scope. Conducts laboratory testing with high degree of accuracy and precision including but not limited to quantitative weighing and dilution, sample handling and processing, instrumental analysis using HPLC, GC, dissolution, UV-visible spectrophotometry, the person, and other techniques as required. Evaluates data to ensure conformance with specifications, expectations, and trends. Identifies and investigates unexpected results. Peer review experimental documentation, calculations, and results generated by other staff for conformance with established procedures and scientific integrity. Works in conjunction with staff to provide scientific contributions toward improvement, troubleshooting, method development and validation. Works through problems with method installation / acts quickly, efficiently, and relentlessly until root cause is determined and solution is found. Provides training and guidance to junior staff on specific techniques as directed by management and specified training plans. Interacts with project teams as required to obtain information, influence decisions, and drive the project forward. Serves as the analytical expert and contributing member on project teams. Works efficiently, minimizing distractions and manages time to accomplish work by expected deadlines. Provides regular reports on progress to leadership and during team meetings. Work in compliance of all US and international regulatory agencies and compliance requirements as they relate to analytical testing. Maintains laboratory equipment and facility. Performs laboratory housekeeping duties as required. Travel as required to outside laboratories to receive training from a qualified laboratory or provide training to a receiving laboratory. International travel may be required.Hard Skills
BS in Chemistry or related science, plus 4 years experience in a pharmaceutical development or QC laboratory (Equivalent combination of experience and education will be considered; ex. PhD in chemistry with analytical laboratory experience).
Familiar with GMP regulations and ICH guidelines
Extensive experience with expertise in the majority of the following: HPLC, GC, dissolution, UV-Vis, X-ray Diffraction, Karl Fischer, IR, PSD, wet chemistry, and USP/EP compendial test procedures.
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Vacancy expired!