Job Description:
Research Associate II (Stability & Surveillance)
Growing, international diagnostics company is expanding their research team! Come work on an amazing, beautiful campus with a team of skilled professionals. This is an exciting opportunity to expand your skills and advance your career!
Summary
This is a role in Stability & Surveillance (S&S) on our Oncology Assay Development team.
Responsible for real time stability testing to support expiration dating of reagents, as packaged under recommended storage conditions, to ensure that label claims are met throughout a product’s shelf life. Work closely across functions, including Life Cycle, Development, Operations/Manufacturing, Quality, Regulatory, and Global Organizations.
This individual will support post-launch monitoring of all on-market products supporting all critical stability activities; and work closely with other S&S, team members, technical leads and cross-functional stakeholders to maintain program compliance, achieve goals and drive improvement initiatives.
Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to support company projects. Exercises technical expertise and discretion in the design, execution and interpretation of experiments that contribute to project strategies. Prepares technical reports, summaries, protocols and quantitative analyses. Presents and discusses results of experiments within department and project team. Maintains high level of professional expertise through familiarity with scientific literature and may participate in conferences and professional societies. Follows company policies and procedures for GMP, GLP, Design Control and others as appropriate. Maintains complete and accurate laboratory documentation and electronic files.
Responsibilities
-Designs a wide range of experimental protocols.
-Executes bench experiments; makes detailed and general observations and analyzes data.
-Prepares technical reports, summaries and quantitative analyses.
-Maintains complete and accurate records.
-Normally receives general directions on routine and new assignments.
-Identifies and implements improvements to work processes and laboratory environment.
-Recognized expert for area of expertise.
-Recognizes and documents activities for publication and/or patent potential.
-Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
-Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
-Participates in cross functional technical teams such as a failure investigation or core team.
-Works well in a team environment by being a productive project team member, suggesting creative solutions to problems and providing input to project planning.
-Establishes interfaces across other organizational groups.
-Trains others in areas of expertise.
-Troubleshoots problems and institutes corrective action.
-Prepares and presents experimental procedures and results in group and project teams.
-Monitors work to ensure quality, and continuously promote Quality First Time.
Qualifications
Bachelor’s degree and 2 years of experience, or Masters – Entry-level
Science Degree in Biology/Biochemistry/Chemistry/Molecular Biology/Microbiology required. Background in immunohistochemistry, histology/pathology, pharmaceutical chemistry, analytical chemistry, biology, biochemistry, or biomedical engineering
Knowledge, skills and abilities
Knows wide range of experimental techniques and skilled in their applications.
Current or previous experience in small molecule or protein analytical methods.
Capable with searching scientific literature to gain general and specific information.
Skilled with use of word processing, spreadsheets, graphical and presentation software applications.
Apply today for immediate consideration to
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or