Specialists in Engineering & Manufacturing Recruiting

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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....

- NY
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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....

- Elmsford, NY
new job!

Software Architect Elmsford, NY / Relocation Assistance Available Competitive Pay, 10-15% Target Bonus, 6% 401K Match, 4 Weeks Vacation, Flex Hours Great Stability/Benefits This opening is with a world renowned medical instrumentation company; with strong consistent revenue growth, dynamic culture, stable environment, low turnover, and ability to work on challenging, complex projects/products. We are seeking an Architect who will provide leadership for a newly developed machine. You will make....

- Various locations NJ/NY, NJ
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 -....

- 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:

- 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....


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....


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


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....


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....

- Bridgewater, NJ

Global Pharmaceutical company in Bridgewater, NJ is looking to a hire a Manager, Medical Education one year, w-2 contract, full benefits and competitive salaryob Summary: The Medical Education Associate Manager is responsible for the development and management of a portfolio of non-accredited medical education programs and speaker management. Principle Responsibilities: (essential job duties and responsibilities) - Develop and execute medical education program plan o Initiate and lead....

- 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....


Global Medical Affairs Director, Immuno-Oncology Our client, a global pharmaceutical company is expanding their I/O portfolio. This is a full-time, onsite, Director level role with the primary focus on immuno-oncology drugs.Company prides itself on a collaborative culture and the opportunity to contribute to purposeful work. Work with Oncology PD-1 products and present data to stakeholders. Lead the medical information review of regulatory documents, publications, labeling, commercial, and....


The Supplier Relationship Manager manages supplier relationships. - Lead and be accountable to CDA, NDA, MSA, Quality agreement, and supplier agreements - Follow business processes and guidelines to act as the center of excellence for legal and financial aspects of the alliance - Contribute to negotiation of contract terms and conditions, including the management of amendment activities. - Contribute to tactical and strategic sourcing activity - Prepare and facilitate quarterly business review


Global Pharmaceutical company which focuses in Rare Disease, Oncology and Infectious Disease is hiring a Biosmaple Operations Manager Must have GCP experience and Sponsor experience (Biotech or Pharmaceutical) One year w-2 contract with full benefits offered Or can go permanent Full time Send resume if interested and qualified:Company is seeking a Biosample Operations Manager to support the clinical teams and to work across its projects as well as with the external biorepositories, assay....


The Clinical Research Physician will be dedicated to providing a leadership role on a matrix team dedicated to stage appropriate clinical development of multiple innovative compounds. He or she will lead the development of clinical strategies for compounds and drive their successful implementation. Essential Job Functions/ResponsibilitiesResponsible for drafting clinical development plans, clinical trial protocol synopses and protocols, and for leading discussions and revisions of study design


Primary Care facility providing services for a large pediatric population is expanding and needs to add a Nurse Practitioner for Pediatrics. * COMPENSATION is 79k to 87k. * JOB TYPE is Permanent/Retained Employee, Full-time. * WORK SCHEDULE is Monday through Friday, approximately 8am to 4:00 pm, which totals approximately a 36 hour work week. * LICENSE and EDUCATION required for a Nurse Practitioner is a application for or possession of a New York State license, DEA#, CPR, PALS, and ACLS. NEW....

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