- Participates on transfer team for new products to internal and external sites (as required), reviews registrational stability studies and conducts gap analysis against Global Manufacturing & Supply requirements. Develops stability data where gaps exist.
- Develops and maintains expertise on the overall stability performance of products manufactured in the global supply chain, including maintaining a working knowledge of the attributes that impact the products' performance/stability profile
- Serves as stability representative on project teams covering postapproval changes, designs and executes required premarket stability program in support of the change
- Perform change control impact assessments and document the stability assessment in change controls. Review and endorse change controls as an expanded reviewer. Initiate change controls related to stability operations
- Provide the technical requirements in a Master Stability Protocol, review and approve study specific protocols and /or batch enrollment forms
- Responsible for the handling of annual commercial stability program for assigned products in coordination with sample management groups.
- Authors stability sections of CTD dossiers for postapproval filings, annual reports, product renewals, Annual Product Stability Reviews, and stability related responses to health authority inquiries.
- Serves as stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues and/or deviations from standards.
- Leads work activities involving Change Controls and CAPA's .
- Identify information regarding stability program that may impact lab capacity, product studies or regulatory commitments directly, escalate promptly to management and act as required.
- Responsible for stability procedures and ensures consistency with site department and Client groups procedures.
- Participate and/or lead OpEx initiatives to streamline and standardize management of stability programs
- Support health authorities inspection internal and external.
- Represents department in cross functional projects
- Ensure training requirements are met.
- Acts as an advisor and mentor to stability staff
-
Applications Scientist
3 weeks ago
Integrated DNA Technologies (IDT) New York, United StatesIDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health. · This position is part of the **_Scientific Applications Support team_** located in the **_United States of ...
-
Field Application Scientist
2 days ago
Leica Microsystems New York, United StatesFor over 170 years, Leica Microsystems has helped shape the future by developing groundbreaking optical and digital solutions. As a global leader, we're driven by continuous improvement to excite our customers and to create the best work environment for our people. Customer focus ...
-
Software Application Scientist
2 weeks ago
Integrated Resources, Inc New Brunswick, NJ, United StatesJob Title: Stability Scientist · Location: New Brunswick, NJ · Duration: 12 Months · Work Schedule: Mon - Fri, Business Hours · Job Description: · 100% onsite · Principle Objective of Position: · • The Principal Scientist Stability is responsible for stability product stra ...
-
Raman Application Scientist
1 week ago
Horiba Instruments Piscataway, United StatesJob Description · Job DescriptionHORIBA is a global group of companies that develops, manufactures and provides an extensive array of analytical and measurement equipment to countries around the world. Horiba Scientific which specializes in scientific instruments has an opening i ...
-
Application Scientist
3 weeks ago
Johnson & Johnson Raritan, NJ, United StatesAt Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. For more information on how we support t ...
-
Application Scientist
3 weeks ago
Synbio Technologies Princeton, United StatesAt Synbio Technologies, gene synthesis is in our DNA. We are at the forefront of innovation that enables researchers to discover more, while paying less. As we continue to grow and expand our horizons, we're in pursuit of an Application Scientist who can seamlessly blend technica ...
-
Rutgers University New Brunswick, United StatesThe Laboratory for Biomolecular Simulation Research ( and Institute for Quantitative Biomedicine ( at Rutgers, the State University of New Jersey, is seeking a drug discovery development and application scientist at the postdoctoral level. The LBSR i Drug, Application, Developmen ...
-
Applications Scientist
3 weeks ago
Danaher New York, United States Full timeIntegrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart de ...
-
Horiba Instruments Piscataway, United StatesJob Description · Job DescriptionThe HORIBA Group of worldwide companies provides an extensive array of instruments and systems for applications ranging from automotive R&D, process and environmental monitoring, in-vitro medical diagnostics, semiconductor manufacturing and metrol ...
-
Work Assistant, Part Time
2 weeks ago
Rutgers University New Brunswick, United States Part time**Position Details**: · - Position Information**Recruitment/Posting Title** · - Work Assistant, Part Time (Multiple Vacancies)**Job Category** · - Staff & Executive - Research Support (Laboratory/Non-Laboratory)**Department** · - RWJ-Child Health Institute**Overview** · - New Jer ...
-
Nutritionist I
1 week ago
Rutgers University New Brunswick, United States**Position Details**: · - Position Information**Recruitment/Posting Title** · - Nutritionist I**Job Category** · - Staff & Executive - Healthcare**Department** · - RWJ-Pediatrics-Gastroenterology**Overview** · - New Jersey's academic health center, Rutgers Biomedical and Health S ...
-
Research Assistant
3 weeks ago
Rutgers University New Brunswick, United States**Position Details**: · - Position Information**Recruitment/Posting Title** · - Research Assistant - Per Diem**Job Category** · - Staff & Executive - Research Support (Laboratory/Non-Laboratory)**Department** · - RWJ-Dept of Neurology · - Pisc**Overview** · - New Jersey's academi ...
-
Research Assistant, Multiple Vacancies
2 weeks ago
Rutgers University New Brunswick, United States**Position Details**: · - Position Information**Recruitment/Posting Title** · - Research Assistant, Multiple Vacancies**Job Category** · - Staff & Executive - Research Support (Laboratory/Non-Laboratory)**Department** · - RWJ-Medicine-General Internal-Meb**Overview** · - New Jers ...
-
Work Assistant
2 weeks ago
Rutgers University New Brunswick, United States**Position Details**: · - Position Information**Recruitment/Posting Title** · - Work Assistant**Job Category** · - Staff & Executive - Research (Laboratory/Non-Laboratory)**Department** · - RWJ-Family Medicine-Research**Overview** · - New Jersey's academic health center, Rutgers ...
-
Bristol-Myers Squibb New Brunswick, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
-
Scientist Iv, Global Pharmaceutical Technical
2 weeks ago
Boehringer Ingelheim Animal Health USA North Brunswick, United StatesUnder the general guidance of a more senior staff member or Head of the department, the incumbent is responsible for developing, validating and transferring robust analytical methods to support testing of APIs, excipients, raw materials and finished products related to marketed/c ...
-
Ad, Bioanalysis
3 weeks ago
Boehringer Ingelheim Animal Health USA North Brunswick, United StatesThe Associate Director, Bioanalysis is responsible for providing expertise in the areas of Ligand binding assay method development and sample analysis, representing Bioanalysis on the project team. Expertise in Mass Spectrometry, Ultra High-Performance Liquid Chromatography, plas ...
-
Labs Fsp
3 weeks ago
Thermo Fisher Scientific New Brunswick, United States**Title: Labs FSP - Associate Research Scientist - Project Management** · **Location: New Brunswick, NJ** · - **This is a Monday**-Friday position on first shift, hybrid position.** · At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a g ...
-
Scientist, Clinical Supply Operations
1 week ago
Bristol-Myers Squibb New Brunswick, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
-
Administrative Coordinator
5 days ago
Rutgers University New Brunswick, United States**Position Details**: · - Position Information**Recruitment/Posting Title** · - Administrative Coordinator**Job Category** · - Staff & Executive - Administrative & Support**Department** · - RWJ-Office of the Dean**Overview** · - New Jersey's academic health center, Rutgers Biomed ...
Software Application Scientist - New Brunswick, NJ, United States - Axelon Services Corporation
Description
Pay Rate :
$70$81
Job Description: 100% onsite
Principle Objective of Position:
The Principal Scientist Stability is responsible for stability product strategy and oversight of product stability programs for commercial small molecules Drug Substances and Drug Products Oral and Sterile.
Activities include those associated with product stability strategy, stability program requirements, authoring / approving stability protocols, and preparation, review and approval of stability reports and regulatory filings.
Major Duties and Responsibilities:
The Principal Scientist stability is accountable for the stability program on assigned brand (s) and acts as StabilityProduct Lead.