Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent will be considered. Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent is preferred.
At least 3 years in regulatory project management preferred, and/or experience in drug/biopharmaceuticals
Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology.
Knowledge of the drug development process ...
• Under supervision, provide strategic and operational global CMC regulatory direction and documentation for MARKETED PRODUCT maintenance. Experience desirable. The following activities may be performed within this capacity:
• Provide and/or implement global CMC regulatory strategy for products.
• Lead or contribute to global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned products, while applying the global strategy into ...
Provides expert technical input and leads the development of scalable, efficient manufacturing processes and control strategies for ensuring product performance in commercialization for oral and non-injection pharmaceutical dosage forms. Works as part of a cross-functional team to ensure design for robustness during product development and transfer.
Leads risk assessment for a range of manufacturing processes for pharmaceutical drug products.
Designs and drives ...
Drug Safety role.... Supporting firm directors and a MD.. pharma experience is ideal. Individual will mainly be collecting data & maintaining it. Individual must be flexible with meeting & greeting the VPs customers and bringing them to a different floor. Individual will have great exposure to executive leadership. She said someone who even went to nursing school but never finished would be ideal.
I. POSITION SUMMARY:
The Coordinator provides communication, coordination and administrative ...
As discipline expert, provides statistical expertise and support on cross functional product development teams to facilitate rapid new product commercialization and product transfers, assuring robust product performance.
· Collaborates with experts within function to integrate statistical methodologies and analysis including design of sampling plans, variance estimations, statistical modeling- to achieve product quality objectives.
· Works with manufacturing globally to maintain ...
Lead cross-functional device development programs from concept through commercialization.
Responsibilities include the selection, development, commercialization support, and lifecycle management of drug delivery devices for various drugs within BMS pipeline.
Identify new technologies for drug delivery and leverage technical judgment, understanding of first engineering principles, and customer needs to assess device platforms against internal and external requirements, with ...
Partner with commercial team to define the delivery device strategy for early pipeline products as well as establish effective commercialization materials for late stage combination products.
Responsibilities include designing market research studies to define and test patient needs and preferences, manage vendor relationships to evaluate device technologies, negotiate contracts and lead device feasibility work, as well as collaborate with cross-functional team members to define ...
Support cross-functional device development projects from concept through commercialization. Responsibilities include the selection, development, commercialization support, and lifecycle management of drug delivery devices for various drugs within BMS pipeline.
Responsibilities include establishing and validating user requirements, translation into product/engineering specifications, design verification and validation activities, design reviews, design transfer and process ...
As the subject matter expert for Quality Control analytical procedures the Associate Director, Global Analytical Technology is a technical expert and individual contributor that will be responsible for validation and operation of analytical methods and able to solve problems and arrive at root cause; will be knowledgeable and current with Health Authority, Pharmacopoeia, ICH, and Pharma Industry standards; knowledge of Research and Development of new drug analytics that will be transferred to Quality ...
Our client is small, unique Oncology company specializing in niche therapeutic products in several different areas of Oncology. Currently selling three unique Oncology compounds, our client continues to produce new breakthrough products as well as in-license products that improve human life, specifically in immune-based therapies. As part of our Clients efforts to expand their specialty sales force, they are looking for the best of the best talent. If you want to be part of this exciting growth ...
Oct 22 -
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