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Operations  [ 34878 ]

Job Category:  Operations Manager   Listed on: 08/19/2019
Location:  Summit , NJ 07901

Consent Specialist, Biospecimen Operations

PREREQUISITES: Bachelors Degree in a life sciences or healthcare related field with 6+ years related professional experience in an academic clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

Summary/Scope

The Biospecimen Operations (BSO) group focuses on management of biospecimens for Celgene sponsored clinical trials. The Consent Specialist will focus on patient informed consent and the management of consent parameters that govern the retention period, use and re-use of biospecimens collected during the course of a clinical trial.
This role will support the BSO Executive Director as a subject-matter expert in patient informed consent and regulatory topics around biospecimens from the perspective of Institutional Review Boards (IRBs), Ethics Committees (ECs), International Health Authorities and country laws/regulations. The Consent Specialist will be expected to optimize processes around interpreting and documenting clinical trial biospecimen consent parameters from study, country and site-specific consent templates for a specific study and upload these parameters into a technology tool.

The Consent Specialist will act as a mentor to peers and is expected to assist them with consent related IRB/EC queries as well as provide training to help develop a group of consent experts within BSO.

Responsibilities will include, but are not limited to, the following:

The Consent Specialist in BSO is expected to review consent documents and interpret consent allowable uses and retention periods in order to maintain adherence to the collection, retention and utilization of biospecimens in line with the informed consent signed by the subject. In doing so, the incumbent is expected to stay current on the broader regulatory landscape related to biospecimens.

• Apply subject matter expertise to the review of informed consent documents, including study, regional, country, and site-level documents, and summarize information regarding use and retention
• Guide CROs and clinical teams on the proper use of protocol and informed consent template materials for the collection and use of biospecimens in Celgene clinical studies
• Provide support for resolving IRB/IEC queries related to biospecimens for Celgene clinical studies
• Assist with the development and updating of policies, standard operating procedures (SOPs) and working procedures (WPs) related to consent oversight. Be able to identify complex biospecimen-related consent permissions. Play a key role in planning and designing clinical trial and biospecimen operations support internally and externally.
• Utilize software tools to track consent parameters, verify and document consent prior to release for utilization, and ensure compliant utilization of biospecimens by following written procedures

Skills/Knowledge Required:

The incumbent should have proficient skills in each of the following areas and have demonstrated application in the context of clinical trials and biospecimen management.

• Clinical Trials: Proficient knowledge of FDA regulatory requirements and GCP; have a demonstrated, intuitive understanding of clinical trials.
• Biobanking: Understanding of global biobanking issues; proficient experience working in organizations adhering to quality standards and working with regulations pertaining to general biospecimen transportation requirements.
• Informed Consent: Subject-matter expertise in patient informed consent and regulatory topics around biospecimens from the perspective of Institutional Review Boards (IRBs), Ethics Committees (ECs), International Health Authorities and country laws/regulations
• Drug Development: Proficient understanding of the drug development process.
• Professional inter-personal skills and excellent oral/written communication. Experienced in presenting to internal and external audiences.
• Basic leadership skills in conflict management, facilitation and negotiation.
• Proficient computer skills in Microsoft Office.
• Experience with consent tracking databases preferred.

Up to 10% travel to conferences to stay up to date on global regulations on biospecimens. The travel is not known at this time but may be required. It could include international travel given one of the legal groups the manager works with extensively is in Switzerland but more likely will be in the US.

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Senior Business Analysts  [ 32560 ]

Job Category:  Business Analyst   Listed on: 06/02/2019
Location:  Union , NJ 07083

Perform bus reqt elicitation, analysis & prioritization, bus process redesign, system testing & implementation. Work w/ relevant s/w technologies incl MS Office, MS Project, Visio or similar diagramming tool, & Excel.

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Validation Engineers  [ 10009 ]

Job Category:  Validation   Listed on: 06/02/2019
Location:  Union , NJ

Author assigned validation docs.  Develop bus. process maps, user req. spec’s, functional req. spec’s, & procedural spec’s.  Review compiled validation package.

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Senior Validation Engineers  [ 10010 ]

Job Category:  Validation   Listed on: 06/02/2019
Location:  Union , NJ

Author & review assigned validation docs.  Review bus. process maps, user req. spec’s, functional req. spec’s, & procedural spec’s. Lead project team & service providers to attain project goals, objectives & milestones. 

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Sales Engineers  [ 25013 ]

Job Category:  Software Engineer   Listed on: 06/02/2019
Location:  Union , NJ 07083

Develop financial & operational estimates based on info gathered from potential customers. Analyze & report on customer behaviors regarding utilization of services. Work w/ .NET, ASP.NET, Java, Oracle, C#, VBA & SQL Server.

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Programmer Analysts  [ 6200 ]

Job Category:  Programmer   Listed on: 06/02/2019
Location:  Union , NJ

Develop & test s/w programs.  Analyze & review user requests for modification.  Program, debug & document systems.  Work w/ relevant s/w languages & technologies. 
All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Computer & Information Systems Mgrs  [ 25012 ]

Job Category:  Information Security Consultant   Listed on: 06/02/2019
Location:  Union , NJ 07083

Plan, coordinate & direct design of computer apps.  Monitor & control project teams’ progress & provide mgmnt oversight. Work w/ MS Project, MS Visio, Oracle, .Net Framework, Erwin, SQL Server.  Travel/relocate to various unanticipated locations to interact with clients and train end users for different long and short term assignments. 

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.                      

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Senior Validation Engineers-Pharmaceutical Systems  [ 31912 ]

Job Category:  Validation   Listed on: 06/02/2019
Location:  Union , NJ

Create validation lifecycle deliverables. Review user & functional specifications, design/configuration specifications, SOPs, & change requests. Develop validation protocols (IQ, OQ, PQ) & create/review test plans, test scripts & traceability matrices. 

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Senior Drug Safety Specialists  [ 32869 ]

Job Category:  Drug Safety   Listed on: 06/02/2019
Location:  Union , NJ 07083

Senior Drug Safety Specialists: Collect, enter data and submit (to FDA) study and post-marketing adverse event drug/device reports received from clinical sites, call centers & GPVs per Local SOPs and Study Protocols. Provide guidance to US PV team on data entry of study cases. Train and mentor new hires on safety database and other applications.

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Drug Safety Specialists  [ 32868 ]

Job Category:  Drug Safety   Listed on: 06/02/2019
Location:  Union , NJ 07083

Drug Safety Specialists: Administer the electronic adverse event database & validated tracking spreadsheets. Collect, enter data and submit (to FDA) study and post-marketing adverse event drug/device reports received from clinical sites, call centers & GPVs per Local SOPs and Study Protocols.

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Research Associate  [ 34780 ]

Job Category:  Research Associate   Listed on: 06/02/2019
Location:  Union , NJ

Carry out lab experiments & analysis for analytical development, as well as provide analytical support for process development & quality control. Conduct experiments/analysis independently & may assist other scientists/analysts with experiments.

Multiple positions available. All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Lab Systems  [ 34633 ]

Job Category:  Specific   Listed on: 04/12/2019
Location:  Morris Plains , NJ 07950

Desktop Lab Systems Engineer

Experience in Pharmaceutical GxP regulated lab area. Perform installation and support of various standalone laboratory instruments following SDLC methodology and utilizing reusable validation tools.


Responsibilities:
• Execution installations of instrument builds/images on laboratory workstations
o Ensure all desktop software is installed, communicating as intended
o Complete desktop installation(s) documentation and collect necessary supporting evidence
• Review instrument software requirements ensuring compatibility and compliance prior to installation
• Troubleshoot and issues that arise during installation or during operational use
• Update installation documentation as necessary to accommodate new or changed requirements
• Ensure resources performing IT activities are knowledgeable of and in tune with latest company policies and Health Authority Regulated (HAR) regulations
• Provide input and guidance for technical strategy as it relates to all GMP computerized systems and address any compliance gaps.
• Ensure all computerized systems remain in compliance post-production
• Troubleshoot client instrument workstation and information technology issues
• Provide feedback and suggestions to the client for future process improvements

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Reliability Engineer  [ 34659 ]

Job Category:  Specific   Listed on: 04/12/2019
Location:  Morris Plains , NJ 07950

Reliability Engineer

Originates and develops analysis methods to determine reliability of components, equipment and processes. Acquires and analyzes data. Prepares diagrams, charts, drawings, calculations and reports to define reliability problems and make recommendations for improvements. Conducts an analysis of reliability problems and investigates to determine the required reliability approach for the particular situation, with consideration given to the cost limitations for equipment uptime/downtime, repair/replacement costs and weight, size and availability of materials/equipment. Determines cost advantages of alternatives and develops action plans that comply with internal/external customer demands for reliability processes/equipment to avoid failures.

Education: B.S. degree in engineering, statistics, mathematics, or equivalent

Experience: Entry level with three to 10 years’ experience

Position Responsibility:
Works under general direction of project engineers or section head, or under general administrative instruction in performing detailed reliability studies and calculations of component/system reliabilities.
Considers impact of costs on recommended action plans for avoiding/correcting problems during the design phase or remedial action for correcting reliability problems on installed equipment; performs root cause failure analysis to help prevent failures.

Plans and performs engineering research, design development, or manufacturing/process engineering assignments, including responsibility for major subsections of complex projects using general engineering practices influenced by the general theme of reliability principles.

Estimates engineering personnel needs and coordinates and supervises the use of other engineers and technicians to accomplish the objective of cost-effective reliability improvements for projects.

Recognizes that assignments are broad in nature and require appreciable originality and ingenuity to complete them and considerable latitude for unreviewed actions or decisions.

Follows company safety and health guidelines and other company policies.

Performs other work as assigned.

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Project Manager  [ 34660 ]

Job Category:  Project Manager   Listed on: 04/12/2019
Location:  Morris Plains , NJ 07950

Need a PM to manage a server upgrade project that will require management of the server configuration, os install, application install and any validation work that will be required.

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Pharmaceutical Change Engineer  [ 32801 ]

Job Category:  Regulatory   Listed on: 04/07/2019
Location:  Union , NJ 07083

Review, approve & provide regulatory triage to change management for records as a quality supporter supporting manufacturing, packaging, testing and release of clinical supplies in GxP environment. Review & approve temporary changes as well as support effort to improve change management. Review/approve GMP Lifecycle Documentation.

Travel/reloc. to various unanticipated locations as req’d.

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