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Head of Product Labeling / Technical Communication Elmsford, NY - Full relocation provided Competitive Pay, Bonus, 4 weeks PTO, 6% 401K, Great benefits We have a new opening for a Head of Product Labeling / Technical Communication with a longstanding client; a multi-billion ($8B+) global medical instrumentation company. They have strong revenue growth, a stable environment, very low turnover, and offer the opportunity to work on customized, complex medical products that impact people's....

- San Francisco, CA
new job!

Vice President, Regulatory Affairs San Francisco Bay Area Our client is seeking a Vice President, Regulatory Affairs who will be responsible for regulatory strategy, oversight, and guidance drug development program. The successful candidate will bring strong leadership abilities to oversee the Regulatory Affairs team, a successful history of effectively leading IND and NDA filings through approval, and interacting effectively with the FDA and other foreign regulatory bodies. This position....

- KS
new job!

overall accountability for and provides oversight to all aspects of operation of the Quality Assurance and Quality Control Lab departments and to serve as a site agent to manage compliance to all cGMP procedures, standards, and common practices. Supports development of the site business and quality plans.Ensures that all operations supporting quality control testing requirements for manufacturing are performed in a regulatory compliant manner.LeadershipLeadership to direct reports, including....

- Danbury, CT

Our client - a growing Pharmaceutical company located in the Danbury, CT area - is looking for a Validation Associate. The Validation Associate will be responsible for supporting all aspects of equipment qualification (IQ/OQ/PQ) as well as supporting process validation programs. The Validation Associate will be involved with creating and implementing various protocols as well as Final Reports. The qualified candidate will have 1-5 years of Pharmaceutical Industry experience - as well as some....


Job Description: We are seeking an experienced and determined professional with a passion for Project Management. As a consultant you will primarily work with clients in the pharmaceutical industry. You will engage directly with key decision makers and have the potential to create true impact. Tasks will mainly relate to Project Management of or within large investment projects. We are looking for a candidate with strong leadership and communication skills who is driven by a desire for....

- Cincinnati, OH

Job Description: Responsibilities include supporting daily compliance and systems activities. Performs audits (internal and vendor audits), supports change control program, complaints and any customer services related to Documentation Center. Also works with manufacturing to identify resolution to events while working with Quality Management. The candidate will perform general QA work, using their ability as a skilled contributor in completing tasks where judgment is required in resolving....


The positions serves as the site’s Oral Solid Dosage (OSD) platform leader and reports directly to the Sr. Director of Process Development. Responsibilities include management and oversight of multiple early and late stage development projects and support personnel. Job Functions: Demonstrates technical expertise in OSD technology and methodologies. Lead site related process development, scale-up, commercialization and tech transfer responsibilities Collaboratively develop project strategies....


Company is seeking a Principal Engineer to lead projects in the Biologics process development and clinical manufacturing projects. The individual will design, develop, scale-up and optimize drug substance and drug product unit operations for protein therapeutics. Experience managing projects from Discovery integration through GMP manufacturing, with both internal and external partners are required. The candidate should have strong technical, communication and interpersonal skills, be able to....

- Buffalo, NY

Provides quality oversight to the Chemistry & microbiology laboratories and product transfer by supporting all work. Work in partnership with the aforementioned groups to produce quality work in compliance with all applicable regulations. - Review/approve deviations, OOS's, OOT's, EE's, and change controls. - Perform audits of the chem & micro labs. - Review/approve protocols, investigative studies, raw data and reports. - Establish and control quality programs to ensure conformance....

- Los Angeles, CA

Salary Range: $110,000 – $130,000/yr. base salary (bonus eligible role) Minimum Requirements:B.S. Chemical Engineering, Chemistry or Mechanical Engineering required7+ years of overall experience with at least 3 years of supervision experienceMust have a background in chemicals manufacturing, ideally compoundingBig pluses would be: lean six-sigma certification Job Description: This person will work in a 100-person manufacturing plant; one side of the plant does catalyst recycling and the....


Responsibilities for 3rd Shift Sanitation Supervisor:Manage cleaning and sanitation employees in a food manufacturing facility on the 3rd shift;Train new sanitation employees in proper cleaning SSOPs, chemical use and safety procedures;Ensure uniform pre-operational standards through inspection and training;Solve concerns in regards to GMP, SSOP, SQF, SDS, and Process Control programs;Inspect plant, stored equipment, and environment for cleanliness;Establish and maintain a Master Sanitation....

- Seattle OR San Fran, Cali, WA

Top tier Pharmaceutical company in Seattle, WA is expanding They are opening new office as well i nthe San Francisco Bay area of Califronia- this role can be located in either location Full benefits-medical/health, 401k and match, stock, LTis and STis...many progressive benefits...competitive compensation and bonus and more... Full relocation to either area The Sr. Director, Clinical Operations Program Management will be responsible for leading all aspects of clinical operations within the....


Top Tier Global Pharmaceutical Company is looking for a Supervisor for Print PRoduction= this is a w-2 contract (for one year and then up for renewal)- includes health, Medical benefits, vacation and more Company is in Jersey City and is moving to Madison, NJ in October (position sits in JC for now and then Madison) Oversees print production of promotional collateral from development to final distribution. Collaborates with creative agencies, marketing teams, and vendors to develop....


Top tier Pharmaceutical company (one n Boston and one in NJ nd one in Seattle)Required:Has completed management of a study or group of studies from planning through close out (Phase 3)Experience with managing VendorsExperience working on global studies with CROs Nice to Have:Experience supporting writing clinical study reports,Supporting sNDA or NDA submissions, Supporting pre-Inspection preparation,Participating in Sponsor Inspections by Regulatory BodiesExperience managing or leading teams....

- Southwest USA, ON

Title: Sr Reg Affairs Mgr Regulatory compliance with relevant regulations managing submissions with regulatory authorities. Ensures compliance with relevant regulations. Manage regulatory documents, pre and post approval.. Education: BS Science Minimum 7+ yrs animal health regulatory experience, Previous relationship with FDA


This world class chemical client is seeking postdoctoral scientists to develop new models and algorithms in the area of Supply Chain and Production optimization, transportation, planning and logistics to improve the sustainability of products and our business in line with the Growth Plan. In this position, you will have the opportunity to help shape how the clients approaches complex problems such as demand forecasting, product placement and supply optimization. Responsibilities: --- Create....

- Greenville, NC

Excellent opportunity for Sr. Chemist to supervise and direct a staff of 6 Laboratory Technicians, conducting non-routine analyses and analyses on substances as part of research projects to evaluate chemical and physical properties. Will provide technical expertise for commissioning and support of all laboratory analytical systems/ instruments (ICP-OES, GC, XRF, N-TOC, IEC, Colorimetry, and Density Meters), promoting the accuracy of analytical data, optimum productivity. Responsibilities....

- Hopkinsville, KY

Our Food Safety Manager is responsible for managing our in-house Micro-Lab and implementing and managing process control systems and preventative actions in the food safety area. You will manage all HACCP and Regulatory compliance issues at this processing site. Client company cannot sponsor or transfer Visa's at this time. Qualifications:Bachelor’s degree in Food Science, Microbiology, Chemistry, Biology. An advanced degree is preferred.A minimum of two years’ experience in Food Safety....


POSITION SUMMARY: Working with minimal supervision, manage complex projects/products, including responsibility for the content, assembly, pre-final review, and filing of major medical device applications (e.g., IDEs, PMAs, 510(k)s) submitted to the FDA and foreign regulatory agencies. Applies regulatory expertise to the evaluation and solution of product development issues. SPECIFIC DUTIES AND RESPONSIBILITIES: - Draft, assemble, and file original documentation and submission materials for new

- Any US State

Our client needs a doctor with experience in oncology clinical drug development to serve as a medical monitor. Work is estimated to take 10 hours per week to start.RequirementsMedical Doctorate (MD) or equivalent5 years clinical drug development experience in oncologyPhase 1 and phase 2 studiesResponsibilities1. Available to clinical investigator sites as a go-to person in the US for checking eligibility2. Be responsible for interacting with sites on safety management of the study. This will....

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