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Director of Quality Microbiology To build and run a new fully compliant QA department for a cGMP sterile 503B manufacturing facility. Key responsibilities:Implement and ensure compliance with US Food, Drug &Cosmetic Act, 21 CFR parts 210 and 211 Section 503A and 503B, and all its related elements such as facilities, documentation (SOPs and validation protocols, etc.), training, reports and recordsManage 503B facility chemistry and microlab for end product testing and environmental....


Top Tier global Pharmaceutical and Manufacturing company in Philadelphia is expanding and looking for a vivacious Customer Service Rep Great opportunity to get your foot in the door with Top company! 50k a year and benefits ($25/hour) send resume to hbr at clinicaldynamix dot com This position independently resolves complex, non-standard or high impact customer related issues. This is not a call center position; rather the scope of this position includes many of the following functions on a....


Senior Director/Executive Director, Clinical Research San Francisco Bay Area The primary responsibility is to provide medical guidance, medical review, analysis and data interpretation from clinical studies. This individual will act as the primary Medical Monitor and oversee the safety of clinical programs. In addition, provide scientific support to the Clinical Development team in the development of various oncology and hematology projects. Responsibilities: Acts as a medical resource to the....

- Somerset, NJ

Global Pharmaceutical company in Northern NJ is expanding and is looking for Tech Reviewer Global 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: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Company markets its products to retail pharmacies,....


Reporting to the Executive Director of Early Development this physician will serve inside the medical sciences group as a leader in Hematology/Oncology early development. This Oncologist will lead early phase clinical development of oncology compounds from first-in-man studies through proof of concept. They will define, design, and execute early phase clinical and translational projects as the initial strategy for drug development. This physician should be trained in Oncology and have....


Specific Responsibilities and Skills:Practical knowledge of GMP, GAMP5 software development lifecycle (SDLC) and experience in the generation of controlled documentsExperience creating, updating and maintaining engineering functional specifications design documents and standard operating procedures (SOP)Experience with Emerson DeltaV Distributed control system (DCS), hardware wiring, applying ISA S88 programming and system infrastructure Experience in Virtualization (Hyper-V), DeltaV Virtual....


Global, Top Tier Pharmaceutical company is expanding and looking for a Strong Leader : Associate Director, US Pipeline Launch and Strategy- Amazing benefits, competitive salary, bonus and other Long Term incentives The AD, US Pipeline & Launch Strategy, is responsible for determining the value and the value-maximizing strategy for a portfolio of new product assets and lead launch commercial execution. ? (MUST HAVE GENERICS, COMMERCIAL OPERATIONS AND FORECASTING) This role also leads the....

- Bethesda, MD

Clinical Advisor needed for prominent Government Program w-2, full benefits and competitive salary and many long term incentives For the Clinical Advisor position, they are looking for someone with:Bachelor’s or Master’s degree in Nursing, Public Health, or a health-related or allied science field.Experience as a study coordinator or a clinical research associate (monitor).Minimum 5 years of experience in an HIV/AIDS clinical research setting.Knowledge of FDA regulations and ICH guidelines....


Research Scientist I/II FOrmulation & Process Development with expertise in pre-clinical and clinical operations related to recombinant proteins.Specific Responsibilities and Skills:Lead development projects, and demonstrate hands-on technical expertise/leadership in the laboratory, independently champion technology development projects, be involved in new formulation evaluation and optimization, define formulation platforms, and write/review development summary reports.Oversee or execute....


Associate Manager on Biologics Outsourcing will work onoutsourced R&D activities related to biologics analytical and process development efforts, including planning and financial tracking, contract establishment, work order and purchase order generation, and timeline and deliverable monitoring. This individual will assist in monitoring the organizations progress against their plan and forecast (Latest Estimate), and for developing and initiating appropriate interventions with key....

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Unless noted above, applicants MUST be authorized to work in the US without Visa Sponsorship. US citizens and Green Card holders ONLY. We do not provide relocation assistance for those living outside the continental US. Please only click apply if you meet the specific requirements of the job listing, you are able to work in the location listed, and are comfortable with the salary range indicated above. Thanks for your interest. We look forward to working with you.