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Position Summary: The Senior Director, CMC Regulatory Affairs will be responsible for providing CMC regulatory leadership and strategy across the organization and to our global partners. The Sr Director, CMC Regulatory Affairs will collaborate with the clinical development team, including the Chief Scientific Officer and drug substance and drug product manufacturers, and others for drug development and manufacturing in the pharmaceutical and biotech industry in accordance with the protocol,....

- Waupin, WI

Provision of pharmaceutical services for offenders in Wisconsin's correctional system through the Bureau of Health Services Central Pharmacy Service in a manner consistent with professional standards and comparable to services delivered in non-correctional settings. Prepares, fills and dispenses prescriptions for drugs, chemicals and supplies on receipt of a proper order from a prescribing practitioner for an inmate/student. Prepares and fills extemporaneous prescriptions and orders....


Summary of the Position: We are looking for a Manufacturing Operations Manager to manage staff, processes, procedures and policies in effort to meet company goals and objectives, included but not limited to Safety, Quality, Compliance and Company Policies and Procedures. Responsibilities include, but are not limited to overseeing the planning, organizing, managing, controlling and evaluating the day to day operations of the department and area of responsibilities in order to optimize....

- Allendale, NJ

Senior MES Engineer Summary: The Senior MES Engineer is responsible for the design, implementation and testing of MES projects primarily for biotech and pharmaceutical clients. Prerequisites: Bachelors of Science degree, preferably in Chemical Engineering or Computer Information Systems is required. A minimum of five years' experience performing batch work, specifically S88 or S95 in FDA regulated industries such as life sciences and food & beverage is required. Prior experience with....


Pharmaceutical company in need of Director or Senior Director to join the Medical Affairs team. The Medical Director will provide support and expertise in the area of psychiatry either Schizo or Addiction as there are two needs In this newly created and high profile role you will serve as the medical affairs strategic lead for our combination oral schizophrenia treatment that is currently in phase 3 clinical development. The Medical Director is expected to establish key medical strategies for....


SENIOR RESEARCH INVESTIGATOR-Liver diseaseRare opportunity to transition from Academia for a specialist in liver disease research. You would work on interdisciplinary teams, where you will function independently in the execution of the experiments but will need to work collaboratively with other team members. Working independently, you will perform design, optimization and implementation of complex in vitro and in vivo experiments in rodents and NHP, and provide cross-organizational support....

- Philadelphia, PA

SENIOR RESEARCH INVESTIGATOR-TRANSLATIONAL RESEARCHRare opportunity to transition from Academia for a specialist in airway/pulmonary disease research. You would work on interdisciplinary teams, where you will function independently in the execution of the experiments but will need to work collaboratively with other team members. Working independently, you will perform design, optimization and implementation of complex in vitro and in vivo experiments in rodents and NHP, and provide....


Position Overview The Sr. Manager will represent Regulatory Affairs for pharmaceutical development projects and marketed products. Working with manager, responsible for development and communication of global regulatory strategy on R&D project teams. Main Areas of Responsibilities The Sr. Manager Regulatory Affairs will ensure technical accuracy and regulatory compliance of all submissions for which they are responsible and ensures that applications are executed appropriately and submitted


Position Overview Plans, directs, and executes product formulation and process development activities in support of development of new products intended for clinical trials and commercialization with focus solid and liquid dosage forms including immediate and controlled/modified release systems. Conducts research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products. Experience in the....


Medical Affairs – Fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. In this highly visible leadership role in Medical Affairs, you will work closely with a cross-functional group that includes....


JAVA SOFTWARE DEVELOPER / SOFTWARE ENGINEER / DEVELOPER Columbia, MD REQUIREMENTS:3+ years of current software development experience with the following technologiesJava and/or JavascriptOracle and/or SQL ServerSQLExperience working for a software development product companyStrong Problem solving skillsAbility to understand and translate business requirementsTeam Based AND individual contributor personality ADDITIONAL SKILLS THAT WILL BE USED IN THIS ROLE - IF YOU KNOW THEM ALREADY THIS IS


Our client - a growing Pharmaceutical company - is looking for Production Supervisors. These positions are all newly created as a result of an ongoing expansion. The Production Supervisors will be responsible for overseeing the activities of employees engaged in the manufacture of sterile pharmaceutical products. These activities will include preparation, compounding, filling and routine facility monitoring. Additional responsibilities will include:Completing production plan by scheduling and....


The Director of Maintenance and Engineering, under the supervision of the Site Leader has direct responsibility of the overall site and related equipment including two separate facilities in a single campus environment encompassing approximately 300,000 sq. ft. Areas of responsibility include project management of all significant site projects utilizing both internal staff and outside contractors, maintenance and procurement input on all equipment related needs for both manufacturing and....


Summary We are currently accepting resumes for the position of Research Scientist in Analytical R and D/Methods Development and Validation. ResponsibilitiesMust be fully capable of developing analytical methods based on experience, literature search, etc.Design, develop, conduct and/or review experiments including method development and methodtransfer; perform methods validations utilizing typical instrumentation including but not limited to LC,MS, GC, etc.Interpret data from routine and....


POSITION SUMMARY: Independently responsible for the efficient and thorough investigation of process deviations and customer complaints, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process. Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, the issuance of....


Accountabilities and Responsibilities: - Engage and lead local IT team resources and business personnel to plan, implement, and support local as well as enterprise IT, laboratory, and business systems. - Be an integral member of multiple global IT and system teams, planning and implementing a global IT vision and infrastructure. - Exercise project management of local IT projects, including schedules, updates, meetings, documentation, resources, and completion milestones. - Proactively....


POSITION SUMMARY The Analytical Instrumentation Manager will be responsible for the management of daily activities in support of all analytical equipment in Quality Control. The manager will assure that activities associated with the testing, release and results reporting of materials, products and components meet established and expected quality, Data Integrity requirements, regulatory and customer requirements. The Manager will regularly interact with departments on site and at a corporate....

- Northern, NJ

Minimum Requirements: B.S. Chemical Engineering, Mechanical Engineering, or Biochemical Engineering degree with 3+ years of post-college experience within a chemical, foods or pharmaceutical manufacturing environment. Candidate must have experience doing the complete design through installation of capital projects with a minimum budget of $50K. Job Description: Our Client is a world class leader in the production of food additives, pharmaceuticals and specialty chemicals. This site is a....


Medical Affairs – Fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. In this highly visible leadership role in Medical Affairs, you will work closely with a cross-functional group that includes....


Boston Biotech looking to increase it’s sales force in response to increased market penetration and product development. This company focuses on in-vitro tissue models in Lung, dermal, intestinal, and eye models as well as human primary cells for use in Pharma, Biopharma, and Academic research. These models replace some of the existing in-vivo models that are available for some testing to produce faster more economical results pushing drug candidates toward clinical endpoints faster. The....

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