Biologics developer seeking PhD or MD plus minimum 8 years industrial experience to lead development of translational strategies and identification of drug-related biomarkers and companion diagnostics, for the support of Oncology clinical trials
*** Conceive, initiate, and execute biomarker strategies for Oncology therapeutics in various phases of clinical development.
*** Identify and implement biomarker assays.
*** Analyze drug pharmaco-dynamic data from various ...
Seeking experience with translational medicine, biomarker identification and companion diagnostics in the contect of Cancer therapeutics development to oversee operations and project management for globa pharmaceutical company.
Shall manage lab and clinical operataions including following activities:
*** Participate in the identification, selection and development of biomarkers and diagnostics for trials.
*** Manage, track and coordinate associated regulatory activities as well as lifecycle ...
Director Regulatory Affairs, Area & Affiliate US/Canada-
PRIMARY JOB FUNCTION:
Candidate will be responsible for contributing to and implementing strategies to support assigned projects within Therapeutic Area (e.g., HCV).
CORE JOB RESPONSIBILITIES:
• Review, compile, and submit variations, new applications, supplements and amendments, as well as responses to Health Authorities as needed
• Development, defense, and implementation of robust Regulatory Strategy and Tactical plan for ...
Senior Director, Regulatory Affairs, Area & Affiliates US & Canada
Primary Job Function:
The function of a Senior Director Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has division and corporate level influence and is generally considered a key opinion ...
Director, Regulatory Affairs CMC
• Lead a team of global regulatory professionals who develop strategy for development and marketed products, and manage the content of global regulatory dossiers
• Key internal leader and driver of regulatory policy and strategy
• Influence the development of regulations and guidance
• Provide executive management with meaningful regulatory measurements and regulatory opinion
• Partner with outside regulatory agencies and trade ...
:: If you meet the qualifications listed below and would like more information contact Mary at 815-756-1221. Attach resume when responding to this posting ::
The Corporate Quality Manager will be responsible for providing assigned customer(s) with senior level quality support throughout the product life cycle; development, testing, auditing, improving and production. Travel a minimum of 25-50%
-BS in biology, microbiology or related field
-5-7 years leading quality initiatives in a ...
Design and implement cross-functional projects related to the research, development, and continuous improvement of Multiplex PCR Assay development pipeline by coordinating application of fundamental biochemical methods, genetics and genomics.
Working closely with bioinformatics, will design assay schemes, define protocols and conduct optimization and validation experiments acting as a project lead.
*** PCR primer, probe and oligonucleotide design and development.
Seeking degree in chemistry, biology, engineering or similar and leadership track record in biological pharmaceutical manufacturing quality compliance who is expertly familiar with biopharmaceutical manufacturing operations, documentation management, training, and auditing.
*** Supervising RA and QA associates and contractors.
*** Oversight of corrective and preventive actions.
*** cGMP and GMP Document management.
*** Coordinating and maintaining cGMP and GMP training program.
Jan 21 -
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