- Formation Bio (New York, NY)
- About Formation BioFormation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug ... clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical… more
- Insmed Incorporated (NJ)
- …for creating and implementing programs that ensure workplace safety, regulatory compliance , and environmental protection for all Insmed locations.Key duties include ... risk assessment, developing safety policies, managing training programs, and ensuring compliance with regulations like OSHA, EPA, and other federal, state and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Syner-G BioPharma Group (Boston, MA)
- …expertise to streamline operations, enhance quality systems, and ensure regulatory compliance , empowering our clients to navigate complexity and deliver impactful ... commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit.Lead start-up activities, including… more
- ValSource, Inc. (Rahway, NJ)
- …projects simultaneously. Strong understanding of EPCMV, Quality by Design and risk -and science-based approaches for compliance are desired. Experience with ... overseeing on-site validation and equipment qualification activities, and ensuring compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- AUROBINDO (Durham, NC)
- …and execute CSV protocols (IQ, OQ, PQ) for GxP systems.Prepare Validation Plans, Risk Assessments, and Traceability Matrices.Ensure compliance with FDA 21 CFR ... or Life Sciences.3-5 years of experience in CSV within a regulated environment ( pharma , biotech, medical devices).Strong knowledge of GAMP 5, FDA 21 CFR… more
- Merck & Co. (Rahway, NJ)
- …ensure successful implementation of project plans.- Escalates issues through the risk log and drives problem-solving and resolution within the team.Operating Model ... experience/deep understanding in drug substance and drug product in biotech or pharma across small and large molecules is preferred Education Minimum Requirement: BS… more
- Merck & Co. (Millsboro, DE)
- …relation to establishing supply strategy and proactive mitigation of supply risk /issues. Lead Stakeholder engagement meetings, schedule routine reviews and be able ... Skills:3-5 years' experience in procurement within the Life Sciences/ Pharma IndustryDemonstrated strong negotiation/commercial skills.Must be capable of prioritizing,… more
- Catalent Pharma Solutions (Kansas City, MO)
- …including equipment, instruments, and software systems, as applicable. Perform support compliance activities such as risk assessments, data integrity effects, ... **Senior Validation Specialist I, BioAnalytics Computer System Validation (CSV) & Compliance ** **Position Summary:** Catalent, Inc. is a leading global contract… more
- Sumitomo Pharma (Providence, RI)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo ... Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in...with PV and cross-functional team members to manage the benefit/ risk profile of assigned products and ensure patient safety.… more
- Sumitomo Pharma (Indianapolis, IN)
- Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the US (Sumitomo Pharma America, Inc.), focused on addressing ... to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo- pharma .com or follow us on LinkedIn. **Job Overview** We are currently… more
- W. R. Grace (Columbia, MD)
- Category Manager - Pharma Chemicals and CDMO Apply now " Date:Nov 20, 2025 Location: Columbia, MD, US, 21044 Company: W. R. Grace & Co. Annual Wage Range:$103,975.20 ... Columbia, MD and locations worldwide. Job Description The Category Manager - Pharma Chemicals and CDMO is responsible for leading strategic sourcing initiatives for… more
- Ascendis Pharma (Palo Alto, CA)
- …and ready to help lead a fast-paced, global pharmacovigilance organization? Ascendis Pharma is seeking an experienced Program Safety Lead to champion safety ... excellence, drive compliance , and shape strategy across our growing portfolio. We...CA and Princeton, NJ. Come join us at Ascendis Pharma , where our core values Patients, Science & Passion,… more
- Astellas Pharma (Northbrook, IL)
- …of America), FDA, EMA, PMDA, ACCME and OIG. Is able to apply legal and compliance knowledge to Medical Affairs activities + Experience in managing large budgets ... ** Medical Affairs Global Strategic Brand Lead, Ophthalmology** Do...of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in… more
- ThermoFisher Scientific (Bedford, MA)
- …Office **Job Description** **Job Description: Director, Quality - Purification & Pharma Analytics (PPA)** **How You'll Make an Impact** Leading quality efforts ... - Develop and implement the Quality strategy for Purification and Pharma Analytics (PPA), guaranteeing consistency with Bioproduction Group and Company objectives.… more
- Ascendis Pharma (Princeton, NJ)
- …including purchase requisitions, purchase orders, and ACH funding for copay programs. Compliance and Risk Management: Ensure compliance with regulatory ... Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company...developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled,… more
- Catalent Pharma Solutions (Morrisville, NC)
- …healthier lives. Catalent is dedicated to delivering unparalleled service to pharma , biotech, and consumer health customers, supporting product development, launch, ... commercial manufacturing for pMDI, DPI and Nasal Sprays. Catalent Pharma Solutions in Morrisville, NC is hiring a Senior...Patient First culture through excellence in quality and** ** compliance , and to the safety of every patient, consumer,… more
- AssistRx (Orlando, FL)
- …consultation to internal leadership, commercial teams, and clients regarding risk , opportunity, and strategic response frameworks. Cross-Functional Collaboration + ... Partner with Product, Marketing, Client Services, Compliance , and Data teams to forecast impact and align...of US healthcare delivery, financing models, reimbursement, and specialty pharma . + Proficiency with data analysis tools (Excel required;… more
- Guidehouse (Chicago, IL)
- …course of study. + 10 years of Life Sciences (Pharmaceutical, Biotech, Specialty Pharma and/or Medical Technology) consulting experience or blend of consulting & ... program design, implementation, and monitoring services to pharmaceutical, biotechnology, and medical device, companies. We support our clients across the lifecycle… more
