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- Buffalo, NY

Provides quality oversight to the Chemistry & microbiology laboratories and product transfer by supporting all work. Work in partnership with the aforementioned groups to produce quality work in compliance with all applicable regulations. - Review/approve deviations, OOS's, OOT's, EE's, and change controls. - Perform audits of the chem & micro labs. - Review/approve protocols, investigative studies, raw data and reports. - Establish and control quality programs to ensure conformance....

- Somerville, NJ

Our client - a growing Pharmaceutical company in central NJ - is looking for a Clinical Operations Manager. The Clinical Operations Manager will be responsible for the planning and execution of clinical trials. The Clinical Operations Manager will: Lead the study team in order to develop the study planHelp select the CROReview study feasibility assessmentsHelp oversee site selection/site qualificationOversee the management of the logistics of clinical material The qualified candidate will have


RequirementsAdvanced degree (PharmD, PhD) with at least three years pharmaceutical or related experience would be preferredOur pharma client needs a Medical Communications Specialist to work with team of medical information professionals to capture unsolicited medical inquiries from health care professionals, consumers, and corporate business partners. Research and respond to requests for scientific/medical information using various search and retrieval techniques and medical literature....

- Marlborough, MA

Top tier Pharmaceutical and Chemical Company in Marlborough, MA is expanding a 6 month full time w-2 contract with benefits (can be renewed up to 4 years) is looking to hire a Data Quality Facilitator This position is responsible for maintaining and/or creating customer contact data content in accordance with established guidelines within Hologic systems. The Facilitator is responsible for supporting the data quality strategy which is to ensure data integrity through data governance. The....


Top Tier Global Pharmaceutical company is expanding and looking for a new AD, Biostatitics Must have heavy statistics experience (ideally in a pharmaceutical or biotech environment. PhD preferred. Salary 130-145k plus bonus , FULL RELOCATION to Irvine, CA Additional financial incentives- Short term incentives, Long Term incentives and stock, tuition reimbursement The Associate Director, Biostatistics position can independently lead one or more projects ensuring the proper design, analysis, and


Have you ever wanted to truly make a difference? Here's your chance... Our client - a premier Pharmaceutical company located in NJ is looking for a Principal Scientist - Analytical R&D. In this role - you will provide Analytical support in the development of cutting edge pharmaceuticals that saves people's lives. The Principal Scientist with perform Method Development/Method Validation for both Drug Substance and Drug Product. This role will provide analytical support for projects from....


Here's another excellent expansion opportunity with a multi-site company! Looking for a high quality individual, groom-able for future advancement. Apply for immediate, confidential consideration. Sr. Quality Manager -- $100-140k plus bonus -- food or dairy product experience -- relocation assistance to Dallas TX area from anyplace USA GENERAL DESCRIPTION: This position reports to the Plant Manager and will direct 3 professional quality positions as well as 12 staff laboratory technicians.....

- East Hanover, NJ

To be considered for this position you must have at least 7 or more years of regulatory affairs experience in the area of In Vitro Diagnostics (IVD) along with hands-on preparation of 510K submissions for IVD products. Strongly prefer someone form the medical device industry (not pharmaceutical mfg). Any experience dealing with face-2-face meetings with regulators (like Pre-Submission meetings) will be considered a valuable asset. Provide regulatory strategies for products, including....


Senior Director / Vice President, Reimbursement and Payor Strategy San Diego, California - Remote is a possibility Join company doing purposeful work, where your leadership can drive success! Our client, a global, growing diagnostics company has a new opportunity for a Senior Director / Vice President Reimbursement and Payor Strategy with expertise to drive payor strategy and executing “in-network” contracts. This role manages private and Federal/State insurance, including Medicare and....


Regulatory Affairs Team Lead New Jersey Massachusetts Our client, a global pharma company has a new opportunity for a Team Lead level professional with Regulatory Affairs/Oncology expertise to drive US and Global Oncology projects. This is a full-time Team leader level role driving regulatory strategy of oncology drugs. Independently manages all regulatory business strategies for oncology products throughout lifecycle. Responsible for the regulatory strategy of submissions for all products as....


Data Manager / Biostatistics Consulting role – RemoteContribute to helping define data standards and data collection modulesReview data with clinical teams for quality and compliance with CDISC data standardsCompile data for outcomes for audits and reviewsAbility to add and extract data from Study Metadata repository and work with tablesWork with clinical trial and R & D teams for accurate data collection and reporting Requirements BS /MS degree in statistics or biostatistics7-10 years’....


Unique Opportunity!This position intersects Coatings / Formulations / Process Engineering / New Application Development / Manufacturing.Looking for a SME Principal Engineer in Oral Solid Dose, preferably an Organic Chemist that has moved from the bench to a coatings manufacturing environment but still involved in formulations, troubleshooting. Company offers cutting edge technology, a leadership role, an opportunity to interface with executive management and provide manufacturing solutions to....


Director, Medical Publications and Communications Northeast Our client, a global pharmaceutical company has a new opportunity for a Director, Medical Publications and Communications professional in the Northeast. Looking for a leader to drive the publication and communication strategy for the pharmaceutical pipeline in a specific therapeutic area. This full-time, onsite, highly visible role will engage key thought leaders while collaborating cross-functionally with project teams in Medical....


Senior Clinical Data Manager, CDM - San Francisco Bay Area Ideal candidate will be onsite in the San Francisco Bay area. Will consider remote with travel into the office for meetings, etc. Candidate must be on the west coast preferably: San Francisco Bay area, Seattle, Los Angeles, San Diego. Our client, a progressive biopharmaceutical company with multiple trials in Phase I-III, has a new opportunity for a Senior Clinical Data Manager professional with oncology expertise in the San Francisco....


SENIOR DIRECTOR, REGULATORY AFFAIRS – CMC Our client, a progressive biopharmaceutical company, has a new opportunity for a Senior Director level Regulatory Affairs professional with CMC expertise in the San Francisco Bay area, to drive US and Global Regulatory projects. This is a full-time Senior Director level role with a primary focus on the discovery and development of oncology drugs. Independently manages all regulatory CMC business for oncology products throughout lifecycle. Senior....

- South Region, MD

Choose a hospital-based career opportunity within our newly renovated laboratory, equipped with the latest technologies! During the consideration and selection process both your interests, skills and our immediate needs will assist in placement within our Core Lab. Hiring Med Lab Technicians and Medical Technologist. Must be able to run chemistry, hematology, coagulation, and urine analysis in accordance with written policies and procedures. Properly ascertain results, make necessary....


Title: Pharmaceutical CMC Manager Oversees research efforts of the CMC team within the Pharmaceutical Development Group. Evaluates needed resources to meet the project expectations for CMC support and anticipates gaps to avoid project delays. Formulates a plan for building the CMC section of each project. Coordinates with key players inside and outside Research & Development to ensure CMC needs are met BS in Chemistry, Engineering, or related science10 years experience in chemistry-related


Requirements BS or higher, life or health sciences 7-10 years of relevant pharmaceutical /biotech industry experience RESPONSIBILITIESStudy Planning & Management Site Start-upPatient Enrollment and MaintenanceStudy ClosureCross-functional Representation Train and mentor junior regional team members such as CRAs and CTAsPrepare regional standard metrics (KPIs, SQMs)Ensure compliance with regional regulations, GCP, and SOPs during the execution of the studyContribute expertise to....


Responsibilities:Develop and implement new food products;Meeting with customers and other departments to target formulations, conduct prototype development and coordinate on-site commercialization of new products;Understands production capabilities;Participates in employee training activities;Maintain records, tests, customer feedback, etc.;Assist quality assurance and food safety efforts for SQF requirements;Maintain membership in food related organizations, publications, personal....


REQUIREMENTS: Looking for advancement opportunities in a small industry leader organization where you can wear lots of hats, make an impact and still maintain work life balance? Do you have the following?Minimum of a BS in Chemistry or Chemical Engineering, advanced degree preferredAt least 5 years of related experience in direct glazing, adhesives, sound damping or polymer/water-based coatingsExperience must include either: 1) Waterbased coating chemist for liquid applied sound dampening.....

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