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Title: Sr Reg Affairs Mgr Regulatory compliance with relevant regulations managing submissions with regulatory authorities. Ensures compliance with relevant regulations. Manage regulatory documents, pre and post approval.. Education: BS Science Minimum 7+ yrs animal health regulatory experience, Previous relationship with FDA


The successful candidate will be responsible for the development and validation of physicochemical characterization methods for topical drug products and raw materials with primary emphasis on particle size distribution (PSD) methods. In addition to the activities above, the successful candidate will conduct particle size method transfers and verifications, develop product specifications, troubleshoot process problems, lead physicochemical characterization outsourcing activities, evaluate....


JOB SUMMARY As a technical leader, the successful candidate will oversee and execute analytical development, strategies related to pharmaceutical product development, e.g. project planning and timelines, experimental design, data evaluation, report writing and review and forming scientifically based conclusions, coordinate studies with other technical groups (Formulation, and Production). The successful candidate will be expected to maintain a high level of expertise within their field and....


Top Tier Global Pharmaceutical company is expanding and looking for two Study Medical Experts (for Clinical) must be Medical Doctor with MD degree Can have experience in oncology or even internal medicine + endocrinology/rheumatology/gastroenterology/etc and have experience with research. Competitive salary and benefits and bonus, 401k, long term incentives and short term incentives and more Provide medical support for the study team:Global primary contact person during the course of the....


Process Development Engineer – Solids Processing Location: Pilot plant near Beaumont TX with main office in NY close to North NJ & NYC Here's an opportunity to make a big impact with zero “corporate red tape”. Get in near the ground floor in this established and well-funded startup company. They are working to develop a “Green” source of traditional petrochemicals used to make plastics! Your success in this position is a key step in the overall company’s success. In this role, you will be....


Top Tier Global Pharmaceutical company expanding in their Boston HQ: TWO POSITIONS AVAILABLE- Snr Scientist II level is Snr Manager at the organization Competitive salary, bonus, benefits - including LTI and STI, Full relocation, bonus, stock, 401k and match and more... If interested send resume to hbr at clinicaldynamix dot come Senior Scientist II, Immuno Biologics - OBJECTIVES: The Immunobiologics group within Immunology Research at Company Boston is seeking an experienced Immunologist with


Minimum Requirements:Ph.D. or M.S. in Chemistry or Chemical Engineering with 8+ years of experienceMust have experience in a PSM-regulated manufacturing or lab facilityMust have experience with: batch reaction, scale up, and ability to adapt new chemicals to existing equipmentIntimate knowledge of organic chemistryPluses would be the following: supervision, experience with process optimization, design through installation of projects, sourcing of improved chemicals, distillation and....


Head of Product Labeling / Technical Communication Elmsford, NY - Full relocation provided Competitive Pay, Bonus, 4 weeks PTO, 6% 401K, Great benefits We have a new opening for a Head of Product Labeling / Technical Communication with a longstanding client; a multi-billion ($8B+) global medical instrumentation company. They have strong revenue growth, a stable environment, very low turnover, and offer the opportunity to work on customized, complex medical products that impact people's....


The candidate must have a strong working knowledge of Materials Characterization methods including size exclusion chromatography, thermal analysis, and rheological analysis and a working knowledge of chemistries, processes, and formulation methods. The candidate should also possess excellent problem-solving capabilities, be able to perform failure analysis, develop testing methodologies, execute materials characterization studies independently, interpret results, and interact effectively with....


Job Summary: The successful candidate will be responsible for the formulation and development of prescription products that meet all technical requirements, such as efficacy, stability, rheological properties, and API particle size, and present aesthetically pleasing characteristics. In addition to the activities mentioned above, the successful candidate will assist in developing product specifications, presenting scientific results, troubleshooting process problems, evaluating stability data,


Job Summary: The successful candidate will take a leadership role in the scaling-up of topical products from the lab to bulk production in a cGMP environment. This entails working with formulators and analytical chemists to understand lab processes, selecting appropriate vessels and equipment for pilot batches, and assisting with start up in Manufacturing. Equally important will be taking a lead role in the development of an efficient, reliable scale-up methodology that can be consistently....


Position Summary: The Manager Strategic Analytics will work closely with members of the Marketing, Finance and IT departments. The analyst will be responsible for creating measurable campaign test designs, building statistical models (Regression, tree-based, time series and more), model implementation, and model monitoring, writing and maintaining SAS code. The ideal candidate will have a balanced background in both Statistics and Business Analytics. The ideal candidate will possess the....


Company BackgroundFor 30 years, this research laboratory has been manufacturing and distributing a variety of enzymes and cofactors used in coagulation research. Their sister diagnostics company provides general purpose and specialty assays to the clinical coagulation laboratory. This diagnostics division seeks an energetic Director of Research and Development with an entrepreneurial attitude and a desire to play an integral role in the growth of the company. Position Overview The Director of....


Our client is a global manufacturer of pharmaceutical products, seeking a Technology Transfer Leader for their facility in the Buffalo, NY area. The Technology Transfer Leader will be responsible for assisting with and/or coordinating the transfer and implementation of projects and technology from development groups to the plant manufacturing site. Responsibilities:Designs manufacturing procedures for new or modified productsPlanning, coordination and oversight of the manufacture of....

- West Palm Beach, FL

Minimum Requirements: B.S. Chemistry, 3+ years of post-college hands on industry experience with organic synthesis and microwave-reactor technology. Industry-wise, they will consider people out of pharmaceuticals, specialty chemicals, electronic chemicals/materials, or other industries closely-related. The ideal person would have experience with a variety of organic compounds and chemical processes. Job Description: This is an opportunity to get in on the ground floor of a new micro-wave....


J. Miles Personnel Services is the agency of choice for technical and professional Manufacturing recruitment across the country. We partner with food, beverage, pharmaceutical, medical device and other non-regulated clients to supply candidates for positions at all levels in the following disciplines: Operations, Engineering, Quality, R&D, Logistics, Materials and Procurement, Safety, Sales, Accounting, Human Resources, etc. Our group currently represents 1000+ open positions....


This position serves as the senior liaison between physicians and the company regarding technical issues. This encompasses, IDE clinical trials, troubleshooting and future product features. The incumbent is expected to act as a mentor for Field Clinical Engineers. The FCE collaborates with Regulatory, QA and R&D.Neuromodulation for chronic pain technology. Hugely successful IPO with a company market valuation currently over $2 billion USD. Ideal candidate will have Neuro and Cardiology....

- Harrisburg, PA

Put your career on track with this multibillion dollar international food company. Get in on the ground floor and grow grow GROW! Looking for individuals with a BS degree in Science, Engineering or Business. You need to have a minimum of an internship in a food manufacturing setting. One to three years operations or in-plant quality experience is preferred. Please note that you will need to be open to relocation and working all shifts. A full relocation package is provided. This position....

- Logan, UT

Put your career on track with this multibillion dollar international food company. Get in on the ground floor and grow grow GROW! Looking for individuals with a BS degree in Science, Engineering or Business. You need to have a minimum of an internship in a food manufacturing setting. One to three years operations or in-plant quality experience is preferred. Please note that you will need to be open to relocation and working all shifts. A full relocation package is provided. This position....

- Stephenville, TX

Put your career on track with this multibillion dollar international food company. Get in on the ground floor and grow grow GROW! Looking for individuals with a BS degree in Science, Engineering or Business. You need to have a minimum of an internship in a food manufacturing setting. One to three years operations or in-plant quality experience is preferred. Please note that you will need to be open to relocation and working all shifts. A full relocation package is provided. This position....

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