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Quality Control Manager/Senior Scientist
New York
ContraFect Corporation, a clinical-stage biotechnology company focused on the discovery and development of protein therapeutics for life-threatening, drug-resistant infectious diseases, is seeking self-motivated and collaborative individuals to join its team and to contribute their talent and expertise. We are looking for positive individuals who will add to our committed and dedicated employee base and contribute to the development of novel therapeutic agents which have the potential to change the therapeutic landscape for treating serious infections.
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Director of GCP Quality | New York
This role will work closely with other departments and requires highly collaborative work ethic. This position is responsible for the leadership on the Clinical Development Team to provide oversight and ensure adherence to GCP Quality compliance. This includes, but is not limited to, hosting Regulatory Inspections as well as third party audits and managing the site response to any adverse findings, including CAPA completion on time and in full. This position defines and executes improvements to the Quality Management System with cross functional and cross-site team members.
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Health Economics & Outcomes Research Lead
Iselin, NJ
The Health Economics and Outcomes Research Lead will have the responsibility to develop and set the strategy for the HEOR function and ensure delivery of related tactics at Helsinn. This role will be responsible for the entire in-line portfolio of products as well as select products in development when required. Reporting to the VP of Medical & Scientific Affairs, the incumbent will work cross-functionally with all internal stakeholders to build a comprehensive HEOR plan with the responsibility to translate evidence into appropriate communication resources for clinical experts and customers.
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Clinical Trial Associate - Clinical Operations
New York
HOOKIPA is seeking a Clinical Trial Associate (CTA) to support our trial managers in the planning and implementation of clinical trials. The CTA will work collaboratively within study teams and across functional areas, under the guidance of a clinical trial manager. Direct prior experience in the field of clinical research is welcome but is not required. The CTA position is a great learning experience designed to introduce a new team member to managing clinical trials at a biopharmaceutical company and is a stepping stone for further development in the clinical trial operations field.
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Sr. Manager/Manager Manufacturing Support
Morris Plains, NJ
This position oversees a multi-shift, 7-day operation of manufacturing support personnel to ensure equipment and facilities are cleaned and sanitized and that assigned areas are in order and ready for manufacturing. This requires strong leadership and management to establish a zero overdue, zero accident and compliant operation. Additionally, the Senior Manager/Manager is responsible for overseeing all facets of media/supplement/buffer preparation including safety, quality, compliance, delivery and costs; as well as being accountable for all maintenance and execution of batch records, documentation of activities and on-time delivery to manufacturing.
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Senior Buyer / Manager, Procurement - Direct Materials | Morris Plains, NJ
The Senior Buyer/Manager Procurement will be responsible for supporting the needs of our Morris Plains sites related to Supply Chain and Manufacturing. This individual will evaluate inventory and demand, create requisitions, generate purchase orders, track orders and ensure timely delivery of requirements. This individual will be the point of contact for Direct/GMP Material Vendors and answer questions and provide them with additional order documentation as needed.
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Senior Manufacturing Specialist- Downstream Production | Morris Plains, NJ
This position is responsible for pharmaceutical manufacturing in compliance with current Good Manufacturing Practice (cGMP). Daily responsibilities include, but are not limited to, ensuring consistent completion of all the planned manufacturing activities assigned to him/herself, minimizing waste of the resources (worktime, materials, and components), organizing workplace to maximize the throughput and minimize risks of errors, documenting activities accurately and clearly as per GDP and operating manufacturing equipment according to well defined procedures.
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Associate Director – Advertising and Promotion Regulatory Affairs | North Wales, PA
Primary responsibilities of this position include being responsible for the review and approval of all U.S. promotional materials and submission of such materials to the Food Drug Administration (FDA) at the time of dissemination for assigned brands; providing promotional regulatory strategy and preparing submissions for advisory comments by FDA and negotiating directly with FDA any changes requested and providing regulatory, policy and standards consultation in the development and implementation of U.S. marketing strategy and promotional programs.
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Oncology Clinical Director | Rahway, NJ
The Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines. Our company's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting and publication. As part of our global team, candidate will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding his/her career.
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Project Manager | Paramus, NJ
PsychoGenics is seeking an experienced life sciences Project Manager who will be responsible for supporting cross-functional efforts for contract studies. Job responsibilities include developing, maintaining, tracking and managing project milestones and deliverables; communicating, documenting and archiving project team activities, risks, milestones, deliverables and decisions; working in partnership with project team members to develop and identify risks and opportunities and execute on project plan and strategy; and ensuring alignment within project teams.
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Senior Research Associate, Surgery/Behavioral Pharmacology |Paramus, NJ
We are looking for a highly motivated Senior Research Associate in behavioral neuroscience. The successful candidate will work in a team of scientists and researchers supporting preclinical studies using rodent models and tests. The main responsibilities of the candidate will include, but are not limited to, conducting preclinical research primarily in the area of pain, and other behavioral assays as needed. The candidate will be responsible for surgeries and/or behavioral studies, proper execution of experiments, and preliminary data analysis.
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Program Manager, GMP and Cellular Therapy QA/QC |New Brunswick, NJ
The Program Manager, GMP and Cellular Therapy (QA/QC) is responsible for ensuring the quality and safety of TCR engineered T Cell Therapy and other products and services by applying expert knowledge of quality principles and practices to the design, implementation, control, monitoring, assessment and continuous improvement of work processes. This role is responsible for overseeing and approving the design, implementation and management of the quality management system for the Cell Therapy Program.
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Manager/Associate Director, Manufacturing Science & Technology | Princeton, NJ
The Manager/Associate Director will principally support the company’s manufacturing commercialization activities by overseeing the successful completion of chemistry, manufacturing and controls (CMC) deliverables according to rigorous scientific and regulatory standards within agreed upon timelines and budgets. Additionally, this position will provide committed and accountable leadership for the team.
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