12 facilities jobs found

We are currently looking to fill a Facilities Compliance Specialist (Technical Writer) position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Facilities Compliance Specialists ensure cGMP compliance for the Facilities Management Department. *This is an onsite position located in Rensselaer, NY* As a Facilities Compliance Specialist, a typical day might include the following: Acting as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance Managing and participating in Facilities Department issues of non-compliance to ensure all activities related to the investigation and resolutions of non-conformities are performed in a timely manner...

The Manager, Global Procurement – Facilities & Capital Equipment, will report to the Associate Director, Global Procurement – Facilities, Capital & Logistics (FC&L) and is responsible for developing and driving strategy for our responsible categories such as facilities services, capital equipment, and construction. They work collaboratively with teammates as well as cross-functionally with partners across all Regeneron campuses. The Manager owns supplier relationship, actively participates in supplier selection, and manages ongoing performance and service delivery. A Typical Day may include: Leading and collaborating with others to solve issues of diverse scope and provide analysis considering current business trends Continuous Improvement projects to improve efficiency and produce high quality work Negotiating internally and externally to get the best value for Regeneron Drafting and negotiating contracts (regional/global), while working with internal legal...

Job Title Legal Counsel, North America Sales and Service (Cambridge, MA) Job Description In this role, you will be a key member of the Philips Legal Function, providing strategic legal support to Philips’ North America Sales and Service organization. Your primary responsibility will be to advise on a broad range of legal issues related to the sale and servicing of Philips’ medical devices and digital health solutions in the U.S. This includes navigating complex sales and technology transactions, as well as ensuring compliance with applicable laws and regulations. This is a high-impact, visible position where you will serve as a thought leader within the Legal Function, offering insights on evolving legal and market trends that influence Philips’ engagement with its U.S. customer base. You will regularly collaborate with stakeholders across all levels of the organization, including executive leadership, to deliver practical, business-oriented legal guidance. Your role:...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

National Account Manager –Government & GPO Who We Are Essity is a global leader in health and hygiene with our corporate headquarters in Stockholm, Sweden, and North American headquarters in Philadelphia, PA. We are a multi-billion-dollar company that is committed to breaking barriers to well-being. Essity does this through innovative brands in the areas of Professional Hygiene, Consumer Goods, and Health & Medical Solutions. Working at Essity is not just a career; it is a chance to directly make the world a healthier, more hygienic and safer place. With impactful innovations coupled with sustainable solutions, we strive to reach more people every year with the necessary and essential solutions for well-being. At Essity you will find a caring and compassionate culture where we remain grounded in our beliefs & behaviors. About the Role Essity’s Health and Medical team is seeking an experienced National Account Manager focused for leading the...

The successful candidate will manage and support the external testing activities within the Quality Control group in support of the company’s quality program. A typical day might include, but is not limited to, the following: Organizing and scheduling external testing to support product release/stability testing under cGMP Managing external data review per production schedule and stability program Performing the single point of contact role with contract laboratory facilities Evaluating and monitoring the performance of the contract labs Coordinating investigation activities at contract laboratories to ensure thorough technical content and compliant documentation Communicating and soliciting input from Regeneron SME’s and Quality Assurance Coordinating the issuance and approval of Quality Agreements with contract labs Authoring Master service Agreements, as necessary Participating in GMP audits to the contract labs Coordinating and leading quarterly meetings...

Regeneron is currently looking for a Principal QC (Quality Control) Micro Specialist to join our Micro Tech Team. This position will specialize in in developing QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods. As a Principal QC Micro Specialist , a typical day might include the following: Identification, introduction, onboarding and initial qualification of alternative and rapid technologies applicable to microbiological assays and procedures. Become the SMEs of this technologies, assays and procedures. Coordinating Test Method validations, studies, and troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime. Builds processes where gaps have been...

This is a leadership role providing Quality and Compliance oversight of site operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. As a Associate Manager Quality Compliance , a typical day might include, but is not limited to, the following:   Ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities and materials management Overseeing site quality systems including but not limited to; Deviations, CAPA, Change Control, Audits (Internal and External) and Customer Complaints Being responsible for review and approval of the following types of documents, relating to area functions: failure investigations, change control documents, corrective/preventative action documents, standard...

Regeneron is currently looking for a QC (Quality Control) Micro Specialist to join our QC Microbiology Tech team. This is a lab based position that will specialize in developing new QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position will be actively involved in supporting Change Controls, data review, and compliance records for the microbiology verification team. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods.    As a QC Micro Specialist, a typical day might include the following:   Leading Test Method verifications, designing studies, and assisting on troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime.  Implement verified methods...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls (CMC) quality and compliance excellence by ensuring Regeneron IOPS maintains effective systems for monitoring, analyzing, communicating, implementing, and influencing global regulatory and industry trends, regulations, and pharmacopoeia. In this role, you will be expected to develop and implement strategies to translate CMC intelligence gathering into action and influence policy and standards for all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence , a typical day might include the following Provides oversight on the IOPS CMC intelligence program Collaborates with the Regulatory Intelligence and GMP Compliance and Inspections teams to support and drive activities that ensure appropriate regulatory intelligence and compliance information is maintained and made available throughout IOPS Monitors and assesses...

This role supports and maintains compliance of QA Operational Team, inclusive of but not limited to QA Operations; Document Control; QA Raw Materials and QA Systems with mandated regulatory requirements and site expectations. As a QA Specialist/ Sr QA Specialist a typical day might include, but is not limited to, the following:   Maintaining regulatory compliance in accordance with current Good Manufacturing Practices (cGMP). Collaborating with Cross functional teams to resolve issues, complete investigations and maintain compliance. Reviewing and approving of the following types of documents: Failure investigations associated with deviations, Corrective and preventative actions (CAPA), Standard operating procedures (SOP’s), GxP documents & Change control documents. Supporting root cause analysis ensuring appropriate CAPA are implemented to prevent recurrence where relevant as a quality approver. Reviewing procedures, policies and other...