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We are looking for a Calibration / Instrument / Metrology Technician who will initiate, coordinate, and administer the calibration program for the facility. They will conduct/coordinate the inspection, calibration, and repair of all instruments, equipment and systems used for the manufacturing and measurement and determination of quality attributes of pharmaceutical products in accordance with current industry regulations and practices in the U.S.A. and the state of North Carolina.Under the....

- Lancaster, SC

We are looking for a qualified individual who has the understanding and knowledge of development of chromatographic, spectroscopic, titrimetric and wet chemistry methods. Implements strategies to ensure effective achievement of scientific objectives. Monitors and evaluates completion of tasks and projects.Roles and Responsibilities:Has hands on knowledge and can begin the development and validation of scientifically sound analytical methods for Product release and stability testing.Familiarity


We are looking for a Quality Control Analyst who will support the Quality Control group to maintain process optimization and manufacturing activities. This person will be reporting to the QC Manager. Primary responsibilities for this position will be: perform QC analysis in compliance to cGMP in line with standards prescribed by USFDA. Maintain compliance to data integrity and cGMP in QC lab in line with standards prescribed by USFDA. Perform IOQ/Calibration for instruments in the QC lab with....


We are looking for Technical Document Reviewer with pharma experience. This position will be responsible for working within the Quality Systems organization supporting the review, development and implementation of harmonized documents, processes and systems. General Responsibilities:Review of documentation from various suppliers and other sites for use at site.Creation of site-specific specifications, standard test procedures, general test procedures, test data sheets and any other....

- Any US State

Position Summary: The Senior Director, CMC Regulatory Affairs will be responsible for providing CMC regulatory leadership and strategy across the organization and to our global partners. The Sr Director, CMC Regulatory Affairs will collaborate with the clinical development team, including the Chief Scientific Officer and drug substance and drug product manufacturers, and others for drug development and manufacturing in the pharmaceutical and biotech industry in accordance with the protocol,....

- Any US State

The Senior Director, CMC Regulatory Affairs will be responsible for providing CMC regulatory leadership and strategy across the organization and to our global partners. The Sr Director, CMC Regulatory Affairs will collaborate with the clinical development team, including the Chief Scientific Officer and drug substance and drug product manufacturers, and others for drug development and manufacturing in the pharmaceutical and biotech industry in accordance with the protocol, standard operating....


Position Overview Plans, directs, and executes product formulation and process development activities in support of development of new products intended for clinical trials and commercialization with focus solid and liquid dosage forms including immediate and controlled/modified release systems. Conducts research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products. Experience in the....


Top Pharmaceutical company is looking for a Senior Clinical Data Manager Contractor in their Madison, NJ office one year contract and can renew up to 4 years at a time, benefits included Description: Position Summary The Senior Manager, Clinical Data Management is responsible for leading internal and outsourced Clinical Data Management activities in support of Clinical Research studies, managing the definition of Case Report Form (CRF) requirements, creation of the Data Management Plan,....


Position Overview The Director Real World Evidence Analytics ensures that real-world evidence (RWE) studies and queries are strategically designed and optimally executed to the highest standards. This research includes data management, programming, and statistical analysis of health claims, electronic medical records, and other observational data sources. The Director also keeps current with healthcare policies, RWE data trends Biopharmaceutical industry, and other developments with other....

- Morristown, NJ

Our Client - a growing NJ Based Pharma company with a focus in Oncology - is looking for a Director Clinical QA This person will be responsible for the management/evaluation of compliance of clinical studies for both the FDA as well as international health authorities. This position will focus on the following activities:Managing clinical records & documentation systemManaging improvements of GCP processesManaging internal audits Assisting with inspection readinessManaging the GCP training

- Rockford, IL

As a key program leader and change agent, our Project Manager is responsible for acting as a business partner to key business leaders in identifying, aligning and prioritizing large cross-functional programs and/or change initiatives. The Project Manager will deliver tangible business results through deployment of project management techniques involving Operations, Packaging, Sales, Marketing, Procurement, R&D and Quality. About the job:Partner with key functional areas to manage the....


Assist in the development of and implement the data management plan for clinical trials. * Pepare data reports, tables and graphs for regulatory submissions, IRB submissions, presentations and publications. * Maintain traceability of data sets used for various reports. * Perform consistency checks and data cleaning functions. * Review data on a regular basis for trends and relationships. * Liaise with Clinical and Scientific research teams on data presentation. * Interact closely with....

- New York, NY

Head of Gene Therapy CMC My client is expanding and looking to bring on a new person to lead CMC for Gene Therapy. The ideal candidate will take on the following tasks:Plan, lead and communicate the CMC related strategies for gene therapy products, including selecting CROs and CMOs.Actively manage CRO/CMOs for process optimization, scalable cGMP manufacture (both Drug Substance and Product) to supply a multi-product portfolio of pre-clinical and clinical gene therapy development....


Director of Clinical Development Cardio This global Pharmaceutical company is the worldwide biologics research and development leader. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Director, Clinical Development in Gaithersburg MD or Cambridge UK, you’ll play a pivotal role in....


Our client is a fast-growing established world leader in laboratory equipment and services, and has an opportunity for a Technical Sales Representative selling out client's line of microwave synthesis, extraction, and digestion instruments and will also include a line of Raman spectrometers. The territory includes ND, SD, NE, IA, MO, KS, MI, WI, MN, OH, IL, IN, KY, and TN. Candidates will ideally be located in Chicago, but other major cities in the territory will be considered.....


Our client is a world leader in laboratory equipment and services, and has an opportunity for a Technical Sales Representative (TSR) for its industry leading analytical instrumentation used in R&D laboratories. The Technical Sales Representative will be responsible for direct sales of mechanical surface characterization instrumentation and services to customers covering OR, WA, ID, MT, CO, WY, & UT with an ideal base close to Portland or Seattle. The product lines include Atomic Force....


This role is for a physician who is excited to help implement a US Medical strategies for a product launch in the migraine space.This physician will be apart of the team providing strategic input and oversight on the development and life cycle management for a monoclonal antibody targeting a novel pathway for migraine. This is a high profile asset getting some impressive results in on-going trials. This is the opportunity to join a growing Neuroscience Therapeutic Area that has commitment from


Senior Analytical Chemist Location: Rockland County, NY (Near Ramapo, Nanuet, & Tappan NY and Park Ridge NJ) Unable to publish the full confidential salary range but we can talk about it! ( I filled in the low salary box but not the high level) An opportunity for a Senior Lead Analytical Chemist to support a process development effort. This is a critically important position since ‘reliable data’ is a key to success as they work to develop a novel process. The position will include a....


POSITION SUMMARY: The Principal Scientist is responsible for method transfer/method verification/co-validation of compendial and non-compendial analytical methods utilized across the company according to written procedures. The testing of routine and non-routine samples where specialized training is essential. Planning and coordination of method transfer/method verification activities in the transfer of analytical methods from the Product Development department or between its facilities.....


Essential Functions: - Knowledge and experience in technologies such as continuous processing, flow chemistry, microwave chemistry is preferred. - Knowledge of and experience with in-situ reaction monitoring technology is preferred. - Knowledge or expertise in principles of operational excellence, six-sigma, and process optimization preferred. - Application of key principles of chemical engineering to work within a matrix-based chemical development team to construct systems and design chemical

41-60 of 92 results