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- Cambridge, MA
new job!

Global Pharmaceutical Company is hiring three Clinical Operations Directors (Vaccine or rare disease or Oncology) This position will be responsible for initiating and leading phase 1 and 2 clinical trials development, set-up, implementation and completion. This will be accomplished by working with the internal project team and through a preferred provider CRO and other external contractors. This role will report internally to the Head of Clinical Operations and work closely with the Regulatory

- OH
new job!

Job Description: The successful candidate will support and assist in the manufacture of pharmaceutical products for commercial and clinical supplies. Where applicable, the candidate may be tasked with scale-up and transfer formulations/processes to production facility, designing and recommending equipment purchases, writing and executing qualification/validation protocols. Troubleshooting of automated equipment for pharmaceutical formulation and packaging and identification and implementation....


POSITION SUMMARY: My client is seeking an engineer to lead projects in support of small molecule clinical and commercial manufacturing processes. The individual will design, develop, scale-up and optimize robust drug product unit operations that provide high product quality at various scales ranging from R&D to cGMP manufacture. Strong collaboration is expected with internal early R&D groups, internal commercial partners, and external third party CMOs. The candidate should have strong....

- Any US State
new job!

Six Medical Director Needs for Pharmaceutical Industry 1. Specializing in Oncology 2. Specializing in Psychology 3. Specializing in Endocrinology 4. Specializing in Neurology 5. Specializing in Rare Disease 6. Specializing in Generics The Medical Director will support the global clinical project team with expert knowledge and insight into the study. Provide medical support for the study team - Global primary contact person during the course of the study for medical/safety questions -....


POSITION SUMMARY: This position provides technical leadership and accountability for computer system validation and ensures compliance with internal and external computerized system policies and regulations. As the Subject Matter Expert, this individual will ensure sites are fundamentally aware of and proactively implement current computerized system validation practices with particular focus on impact to patient safety, product quality and record integrity. Position scope includes local and....

- OH
new job!

KEY AREAS OF JOB ACCOUNTABILITY: (list of key objectives and quantifying standards) The holder of this position is charged with leading effort to prove control of the critical aspects of company operations, whether these relate to process, cleaning, equipment, utilities, computers or other elements. Specific emphasis will be placed on Process and Cleaning Validation.Subject matter expert in at least two main area of validation ( Process/Cleaning/Equipment /Utilities /Facilities/Computer....

- NY
new job!

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....

- Swifwater, PA
new job!

Global Pharmaceutical and Vaccine company is expanding the Marketing division: Objective: To maximize company dose and dollar sales volume in a manner consistent with profit goals. Expectations: ·Achieve forecast as planned. ·Develop realistic and achievable forecast in concert with Marketing and Sales Management. ·Use information systems and reports to monitor and direct the progress of sales and profits toward monthly, trimester and annual sales objectives. PRODUCT LINE MANAGEMENT Objective:

- Mahwah, NJ

My client seeks a Toxicologist in their dermatology group to take on the following tasks:Plan, execute and direct toxicological studies and provide data assessmentsSelect, procure, and monitor toxicology studies at CROsEnhance current testing methods and provide regulatory supportUse and help develop in silico toolsOrganize and manage peer-review publication efforts including writing and editing papers for publication & corresponding with journal editors and publishersThe ideal candidate....


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....


General Job Description: This position would support drug product packaging and combination product development on cross functional teams through all phases of development. Engineer would evaluate materials and designs, execute design verification, prepare design control documents and support usability/human factors assessments. Key Area of Responsibilities: Key areas of responsibility for Human Factors and Design Control Engineer include:Evaluate materials, design, and configuration of....


Publicly traded Boston based pharmaceutical company is expanding and looking for: experienced Associate Director of Clinical Trial Disclosure and Transparency to lead, define, execute, and efficiently manage clinical trial disclosure and transparency activities. This newly created position will report to the Head of Medical Writing and will be a key player in evaluating, developing, and implementing efficient, quality compliant processes and systems to ensure overall effectiveness. In....


Process Controls Engineers with DeltaV experience needed for reputable award-winning Automation and Control Systems Integration company. Great chance to use your industrial automation experience within the Biotech, Pharmaceutical, and Food and Beverage industries. Why work here?:Stable business for 25 years and growing!Fun and professional environment with over 120 employees!Variety of projects in several industries, many pharmaceutical and biotech projects!Training provided on new technology....


Require a highly motivated and experienced individual for the position of Sr. QA Associate II. This individual will be part of the External Commercial QA group. Responsibilities include supporting Supplier Quality Management activities. Performs vendor audits, supports changes, complaints and queries related to external vendors. Troubleshoots issues, develops and implements effective risk mitigation strategies as required. Collaborates with site operations to insure site expectations of....


GENERAL DESCRIPTION:This position provides leadership to the manufacturing department engaged in the production of both clinical and commercial drug products. The Associate Director ensures that the production department is adequately staffed with properly trained, knowledgeable employees who perform their duties according to approved Manufacturing directions, Standard Operating Procedures, company guidelines for safety and environmental compliance, as well as current European and US Good....


POSITION SUMMARY: Seeking an engineer to lead projects in support of small molecule clinical and commercial manufacturing processes. The individual will design, develop, scale-up and optimize robust drug product unit operations that provide high product quality at various scales ranging from R&D to cGMP manufacture. Strong collaboration is expected with internal early R&D groups, internal commercial partners, and external third party CMOs. The candidate should have strong communication


Our client, a fast growing Pharmaceutical Company, is currently looking for a Manager - QC Microbiology. The Manager – QC Microbiology will be responsible for the labs that provide testing support for the Company's Sterile Products manufacturing sites. These labs are responsible for all microbiological related testing. The Manager – QC Microbiology will possess strong knowledge of cGMP's, FDA, USP etc. They will also possess the ability to lead and maintain the development of Microbiology....

- Cambridge, MA

Summary of Key ResponsibilitiesProduce high quality and on-time writing deliverables.Plan, write, edit, and format key documents with minimal supervision, including clinical protocols, investigator brochures, clinical study reports, integrated safety and efficacy summaries and related documents. Other documents may include informed consent forms, health authority briefing books, and scientific publications.Facilitate efficient review and finalization process for documents produced internally....

- Greenville, SC

Reporting directly to the Quality Systems and Compliance manager, the Quality Auditor will have responsibility to audit scheduling, planning, execution and documentation of quality system audits of internal processes for the Greenville location. This position will also be responsible for maintaining a library of standards and for reviewing all applicable regulations, standards and communicating requirements to site leadership. This position will provide cGMP / GXP, technical and auditing....


Global Pharmaceutical company is hiring a Director, Scientific Communications- VERY COMPETITIVE base salary, bonus, stock and other Long Term Incentives Succesfull Pharma with marketed products and pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Company has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing....

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