Stability Associate Scientist

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".Job Title: Stability Associate ScientistLocation: New Brunswick, NJ Duration: 06 monthsPay rate: $55.39 hr on W2Job Description:Min 50% onsite required(Need to be flexible to be onsite more than 50% if needed as instructed by manager)Work Schedule: Mon-Fri(normal business hours) Job Responsibilities:Provide administrative support to enrollment activities (form creation, archival, tracking, etc.)Draft stability requirement documentation and support management of enrollments as required.Enrollment forms: initiate GMP forms, and help ensure completion, review, and approval by contributing functions.Escalate information regarding impact to stability program promptly.Ensure training requirements are met.Maintain cGMP practices and comply with HA expectations.Designs and authors stability protocols in accordance with global stability guidelines to support clinical use and registration of biologics drug substances and products.Analyzes and trends stability data. Can identify issues, summarizes and presents results from stability studies and authors technical memos and reports.Authors the stability section in investigational and registrational global filings and responds to stability-related questions from health authorities within the established timelines.Proposes label storage statement and shelf life for drug substance and drug product.Manages protocol and stability data reports in LIMS. Knowledge And Skill:Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry, a related discipline.Minimum 4 years of experience.Problem solving ability, interpersonal, oral and written communication skills; as well as technical writing skills.Able to prioritize objectives from multiple projects, adhering to scheduled timelines.Work independently and contribute to a team based environment; promoting a high commitment to business goals and puter skills required: Microsoft Office applications. LIMS skills are desired.Excellent organizational skills.A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in a biologics manufacturing facility.Contacts:Direct daily interaction with all staff and management Global Biologics Stability. Regular interaction with network departments within and outside of the facility as required in the conduct of assigned work.Decision Making:Exercises judgment within generally defined practices and policies in developing improved business processes. Coordinates with customers and technical experts on decisions and applies appropriate notification to management.About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunitiesASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Created: 2025-02-21