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In this role, you will be responsible for oversight of manufacturing engineering projects including: programming modifications of machinery and equipment, specification and procurement of new equipment and tooling, equipment installation and start-up, and supervision of team members (which can include maintenance, CAD operators, mechanics, and electricians). Responsibilities: Perform automation/controls programming and engineering functions in accordance with accepted practices and company....


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....

- Lexington, KY

Company Overview: This company has been a client of mine now for almost 3 years and I can definitively say that they are unique. From people I have placed here, to my own firsthand experience in visiting their facilities and talking with their people, they do things differently. They take care of their employees, they (truly) care about their customers and they are growing quickly. Their offices in Lexington KY (population 300,000+) are right off of the Bourbon Trail and are located 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....


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....


The Director, Clinical Pharmacology acts as the primary clinical pharmacology lead providing clinical pharmacology expertise to a multidisciplinary study team. The Associate Director/Director, Clinical Pharmacology is responsible for clinical pharmacology programs for assigned projects and will be the key expert on all clinical pharmacology & pharmacometrics matters relating to assigned projects. The Associate Director, Clinical Pharmacology will work in close collaboration with different....


Reporting to the Vice President, Drug Development-Generics, the Director, Project Management will use the global PDP (Product Development Process), allied systems & tools, to plan and manage/coordinate resources and activities related to product development and maintenance of business projects throughout Global R&D, and other company organizations. Responsibilities: Responsibilities:Champion and lead projects for new generic product development.Management of project team members from....


POSITION OBJECTIVE: The Senior Manager, Clinical Supply will be responsible for end-to-end drug supply planning activities across the Client clinical portfolio and for leading the clinical drug supply team. Responsibilities include forecasting supply requirements across the clinical portfolio and managing IP (Investigational Product) production and distribution process on time, with good quality, in compliance with Health Authority regulations/guidelines and Client SOPs. Collaborates and....


Associate Director Global Process Automation and Manufacturing SystemsSummaryResponsible for all process automation systems and manufacturing execution systems used to support Pharmaceutical Operations. Responsible for managing a global group of engineers accountable for the development, implementation and operational support of the next generation manufacturing execution philosophy and associated computerized systems for all batch processing activities.Job DescriptionThis leader in the global


POSITION OBJECTIVE: Responsible for leading the CMC (Chemistry, Manufacturing and Controls) regulatory function, the Senior Manager, Regulatory CMC will collaborate cross-functionally to develop the CMC regulatory strategy, provide guidance to broader CMC functions, and drive CMC regulatory filing(s). Working collaboratively with senior leadership to develop CMC regulatory strategies for one or more investigational and/or commercial products this position will lead the preparation and filing....


POSITION OBJECTIVE: The Director of Clinical Pharmacology and Drug Metabolism and Pharmacokinetics (DMPK) is responsible for overseeing internal and external activities associated with understanding the absorption, distribution, metabolism and excretion properties of multiple drug candidates in preclinical and clinical development. The person will play an active role on cross-functional program teams, this includes planning development strategies and interpreting data, as well as making....


Overview: The Surgical Regulatory Affairs Sr Manager handles all regulatory development aspects of surgical devices. The incumbent participates on the product development team to provide regulatory guidance for surgical devices assigned. They also manage relevant regulatory strategy components and interactions with Regulatory Authorities for their assigned surgical products and may perform due diligence efforts on new product opportunities. Responsibilities: Responsibilities may include but....


Executive Director, Clinical Operations The Executive Director of Clinical Operations is accountable for the overall operational strategic planning, oversight and delivery of clinical development programs. The Executive Director is accountable for the line management of Clinical Operations staff, including development, coaching, talent planning and performance management. The Executive Director will also lead key strategic Clinical Operations organizational initiatives and be a member of the....


Our client seeks a Clinical Research Operations professional to plan their Phase I Clinical Trials Requirements Bachelor’s Degree in life sciences or healthcare field. Additional coursework in clinical trial design.Ability to travel as required (up to 25%).12+ years of proven experience in clinical research and/or clinical trial operations, including a minimum of 7 years in a supervisory role managing (internal/external) clinical operations staff.Industry experience within pharmaceutical....

- Greenwich, RI

The Senior Automation Engineer reports to the Director of Information Systems. The position is responsible for providing project leadership and daily operational support to the Automation Engineering team. Sr. Automation Engineer for new plant being built at this site. Responsibilities: Applies advanced Automation engineering principles to the design and implementation of system modifications, experiments and/or capital projects; develops, organizes, analyzes and presents interpretation of....


We have a critical opening for a Director of Systems Engineering with a global medical manufacturer; an organization dedicated to ongoing success by hiring top talent, investing in R&D, and commitment to engineering excellence for over 100+ years. This role will manage a team responsible for the integration, verification and characterization of automated medical devices to provide rapid and accurate diagnostic testing for clinical laboratories. From an engineering standpoint these....

- Madison, WI

Our client is a biopharmaceutical manufacturer and they need to add a couple of Maintenance Mechanics to their operation, both first and second shift. You will be responsible for the maintenance of machinery, buildings, and equipment. This is a growing organization that you can build a career with. Duties:Conduct daily reviews of utility and production support equipment.Make preventative maintenance checks and inspections in area of trade specialty. Adjust and calibrate equipment when....

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