- United Therapeutics (Morrisville, NC)
- …are as follows:** **Who We Are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public ... a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.… more
- J&J Family of Companies (Raritan, NJ)
- …criticality analysis + Develop and implement manufacturing process improvements, validation strategies, and troubleshooting plans. + Support regulatory filings by ... technical projects + Present to health authorities during inspections + Develop validation approaches and technical strategy for implementation of key initiatives +… more
- Lilly (Lebanon, IN)
- …constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly's ... in and support training and engineering runs. + Responsible for supporting validation activities and ensuring GMP production areas are within compliance. + Support… more
- Cambrex High Point (Waltham, MA)
- …the transformation of research, development, and manufacturing across the pharmaceutical and fine chemical industries where organic chemistry underpins product ... campaigns. + Author and review process development reports, batch records, validation protocols, CMC documentation (eg, Module 3), and regulatory filings (IND,… more
- Reckitt (Parsippany, NJ)
- …and embellishment of finished products, custom manufacturing organizations, R&D projects validation and Consumer Relations. This position is responsible for ensuring ... Business Unit. + Quality oversight of R&D projects risk assessment, validation and implementation with manufacturing sites - specific coordination with internal… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to be a Product Quality Lead (PQL), Quality Assurance, in the Pharmaceutical Development and Manufacturing (PDM) organization. The PQL is a strategic matrixed ... The successful candidate must have experience in a biotechnology and pharmaceutical development environment and strong knowledge of cGMP quality systems. **This… more
- Cook Medical (Pittsburgh, PA)
- …end-users to ensure user requirements are met.* Actively participate in validation risk assessments and various reviews meetings supporting solution delivery.* ... Execute commissioning; supports computer system validation team's installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)… more
- Mentor Technical Group (PR)
- …MTG has the knowledge and experience to ensure compliance with pharmaceutical , biotechnology, and medical device safety and efficacy guidelines. With offices ... routine technical problems of limited scope. * Comprehensive understanding of validation protocol execution requirements. In-depth knowledge of validation … more
- Endo International (Rochester, MI)
- …in-process materials, stability & finished products, and testing to support process validation . Has demonstrated competence in conducting all types of physical & ... with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Participates in troubleshooting analyses and instrumentation. Trains… more
- Curia (Rensselaer, NY)
- …Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. Join our talented workforce, where a ... Change Control Management, and CAPAs + Supervise and perform pharmaceutical analysis to support drug product manufacturing Education, experience, certification… more