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- Lodi, NJ
new job!

The Manager Regulatory Affairs will be responsible for the following: Leading the preparation and filing of regulatory applications (IND, NDA, BLA).Coordinating/meeting with various functional areas in order to identify and obtain information required for regulatory submissions.Developing and/or reviewing regulatory documents (IND, NDA, BLA) in order to ensure that all submissions are of high quality.Leading the preparation of responses to questions from Regulatory Authorities.Developing and....


A large, independent engineering and technology services firm is hiring in multiple locations! Why join this company?Job security - due to the industry they serve their solutions are in high demand and they're hiring to try to keep up! However, they avoid having all their eggs in one basket and are diversified in other areas as well.Competitive Pay along with overtime and generous bonus planTravel is not excessive - you are only at job sites during installation, commissioning, and testing;....

- Boston, MA
new job!

NO VISA's Our client is a rapidly growing company that is on a mission to reinvent the way scientific research is done. They are a SaaS company that bridges software, hardware, and innovation. You will be responsible for architecting, managing and scaling the entire IOT platform that is built on Rancher/Docker and AWS. The RoleTake ownership for health, scalability and availability of our cloud services and IOT platform.Automate the deployment pipeline between our pre-production to production....

- Florence, SC
new job!

Great opportunity to join an expanding global leader as the site Manager, Analytical QC laboratory with responsibility to provide internal and external customers with accurate, reliable and timely test results for raw materials, in-process and finished goods for this cGMP compliant environment. Strong leadership skills are required to develop, train and manage a team of chemists and technicians supporting this 4 shift operation. Responsibilities: --- Manage and direct the Quality Control/....

- Greensboro, NC
new job!

Join a Global Company as the strategic North American (NA) Team Leader supporting Analytical/ Synthesis (Methods Development); Product Metabolism, Product Safety (registration); and Regulatory Compliance (EPA). Participate on the Global Leadership Team while developing a challenged, problem-solving analytical team responsible for performing/ delivering scientific studies to ensure a sustainable product safety and registration success. The successful candidate will have a strong background in....

- Pittsburgh, PA
new job!

Director of Regulatory and Clinical Operations The ideal candidate will take on the following tasks: · Contribute to the strategic planning of the company’s regulatory affairs · Lead the implementation of the company’s regulatory strategy and provide evidence-based opinions and advice · Manage all relations with FDA and 510k submission · Provide management with continuous input on regulatory matters and their interactions with business development, clinical development, commercialization,....

- Madison, NJ
new job!

Top Tier Global Pharmaceutical company is expanding and looking for two Medical Director (for Clinical) must be Medical Doctor with MD degree Can have experience in oncology or even internal medicine and have experience with clinical development. 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 study for medical;Responsible for content of....


QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES: Good understating of cross-contamination, personal hygiene and GMP's Good written/verbal skills Follow all applicable safety....


Director of Regulatory The ideal candidate will take on the following tasks: · Contribute to the strategic planning of the company’s regulatory affairs · Lead the implementation of the company’s regulatory strategy and provide evidence-based opinions and advice · Manage all relations with FDA and 510k submission · Provide management with continuous input on regulatory matters and their interactions with business development, clinical development, commercialization, financial planning,....


SENIOR SALES ENGINEER - FACTORY AUTOMATION - CHICAGO IL The role is based in the Midwest Region and offers a company vehicle and the flexibility of working in the greater Chicago, IL Under minimum supervision, you will execute a comprehensive sales effort focused primarily on securing new OEM customers for the company in order to grow revenue and increase market share. OEMs utilizing servo motion, robots and variable frequency drives will be the primary target focus.Position Duties and....

- Cranford, NJ

Global Pharmaceutical company is hiring a Clinical Trainer for their growing company. salary 80-110k with full benefits ad long term incentives Our Clinical Trainer is responsible for identifying and implementing Clinical Development staff training needs. They may benchmark Athenex Clinical SOPs and insure SOP training is completed and up to date. The Clinical Operations Trainer may also periodically co-monitor and evaluate staff performance and provide guidance for performance, improvement....


Job Description: We are seeking an experienced and determined professional with a passion for Project Management. As a consultant you will primarily work with clients in the pharmaceutical industry. You will engage directly with key decision makers and have the potential to create true impact. Tasks will mainly relate to Project Management of or within large investment projects. We are looking for a candidate with strong leadership and communication skills who is driven by a desire for....


The Head of Device SRM (Supplier Relationship Management) manages device supplier relationships. This is a strategic role that will develop and implement internal policies and be influential in decision making across major functional areas: - Develop and manage Suppliers for clinical and commercial devices - Development and implementation for legal and financial aspects of the alliance - Contribute to negotiation of contract terms and conditions, including the management of amendment....


Director Analytical Method Development & Validation (GMP BiopharmaceuticalPhD preferred or MS with LOTS (5+ mgt, 10+ GMP)Analytical Method Devt, qualification and validation experience requiredComplex and New Method workLarge Cell experience is a mustWould love to have protein Characterization and analyticsGMP and STRONG leadership (team up to 60-100), Financial Management


Specialty Pharmaceutical company is expanding the Somerset, NJ location- Looking for a Supervisor, QA Documentation This position serves as a dedicated resource for the administration of controlled documentation and documentation systems at the companys Somerset site. Associated documentation, systems and activities provide support for all facets of material, process and product development, validation, manufacture, testing, storage, service and distribution. It also applies to controlled....


Global Pharmaceutical company in Northern NJ is expanding and is looking for Packaging Mechanic Serialization Our company is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmic, injectables, oral liquids, OTCs, topicals, inhalants, and nasal sprays. We market our products to....


What We Are About: If you are looking for a stable, reputable and dynamic company to work with a rich tradition of meeting the construction needs of the East TN region, our is unparalleled. It is of the highest importance to us, to provide the best service to our large number of relationships we have been able to make and maintain throughout the community.Our clients seem to be drawn to the fact that we strive to understand their business and how they got to where they are. They recognize that


JOB PROFILE: Responsible for the laboratory testing, formulation modifications, quality assurance functions of a growing Sanitation Chemicals operation. This is very much a hands-on role requiring a chemistry background. ISO compliance REQUIREMENTS: BS Chemistry or similar degree Laboratory testing, formulation experience ISO experience No state income taxes, reasonable cost of living in Central Florida

- work from home, FL

Global Pharmaceutical company (headquarted in West Palm BEach, Florida) is growing and needs a Strong Clinical Research Associate for oncology trials. Must have five to eight years of experience with at least two years of oncology experience. CRA can work remotely form home but be willing to travel to and from sites (see travel information below) This job includes base salary and generous benefits and long term incentives. Role: We are seeking an experienced Clinical Research Associate for....


Top Tier Global Pharmaceutical company is expanding their Austin, Texas location $25-30/hour on w-2 with full benefits For the perfect fit for the level III position, it would be someone who also possesses the below mentioned level II experience, with possible experience as a supervisor. (This role is an introductory lead/supervisor position who will oversee the work that the two level II specialists will be producing). Furthermore, previous experience interacting with sites of manufacture.....

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