- Merck & Co. (Rahway, NJ)
- …& Technology (DD&T) organization designs, develops, and commercializes novel biologic/ drug / vaccine - device enabled combination products to achieve safe and ... technical integration, assembly automation, etc.), as well as members of internal cross-functional product development teams from concept through product launch. The… more
- Merck & Co. (Rahway, NJ)
- …environment that provides substantial technical responsibility and leadership of internal and external work.The Senior Scientist, Engineering position leverages ... expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a pivotal… more
- Merck & Co. (Rahway, NJ)
- …Our Team as an Associate Principal Scientist/Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a significant impact in ... forefront of innovation in the-Manufacturing Division, specifically within the-Biologics Drug Substance Commercialization (BDSC) team. Our Downstream Purification-department is… more
- Merck & Co. (Rahway, NJ)
- …Clinical Research, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, Drug Development, Good Manufacturing Practices (GMP), Inventory Control ... contact representing the GCS Planning organization to customers both internal and external to GCS and serve s as...the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . - Works directly… more
- Eisai, Inc (Exton, PA)
- …with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control , Validation, and other internal (PST) and external functions ... focused on the technology transfer, scale-up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug Intermediate (ADI) production… more
- Merck & Co. (Rahway, NJ)
- …. This individual serves as the primary GCS point of contact to stakeholders both internal and external to GCS and serve s as the GCS spokesperson at clinical ... establish a consolidated , visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).- - Responsible for authoring clinical supply… more
- Tris Pharma (Monmouth Junction, NJ)
- …the organization. Ensures compliance with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Occupational ... continuity of supply while optimizing cost, quality and delivery for internal and external stakeholder satisfactionCollaborates cross functionally with internal … more
- Merck & Co. (Rahway, NJ)
- …strategies related to upstream processing and recombinant expression of drug candidates in early- and late-stage development.Responsibilities include, but are ... conference participation.Represent BPR&D as a upstream bioprocess expert/co-leader in internal and cross-functional project teams.Supervise, coach, and develop talent… more
- Insmed Incorporated (San Diego, CA)
- …As the Sending Unit, will facilitate transfer of analytical procedures to a Receiving Unit ( internal or external QC). May act as a program lead on a PDT as required ... Development Team representative as an Analytical Lead for a drug program.Key Responsibilities:Responsibilities include developing and optimizing analytical methods… more
- Insmed Incorporated (San Diego, CA)
- …business strategies.Facilitate collaboration with both internal and external drug substance analytical, quality control , quality assurance, and manufacturing ... and status of projects by giving oral updates or internal presentations.Actively seek opportunities for continuous improvement.Assist other departments and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …global manufacturing network for best-in-class CAR-T product.Work collaboratively with internal and external partners to drive global process platform improvements ... on process platform parameters, unit operations and analytical methods at both internal and external CMO sitesEnsure global records are consistent and maintained to… more
- Merck & Co. (Rahway, NJ)
- …(SM PR&D) organization. The SSO pilot plant enables gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing ... development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of a variety of reagents,… more
- Merck & Co. (Rahway, NJ)
- …advice to stakeholders creating optimal development, commercialization, and drug /delivery device supply strategies-Building our leadership and functional capability ... regulatory activities with cross- product or cross-functional impact, including drug device/combination products and software as medical device platforms.- Reviews… more
- Merck & Co. (Rahway, NJ)
- …processes while develop ing technical strategies related to downstream processing for drug candidates in early- and late-stage development . - - Responsibilities ... and patent - - Represent BPR&D as a downstream bioprocess expert in internal , cross-functional project teams and external conferences / consortia - Mentor and… more
- Merck & Co. (Durham, NC)
- …seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate ... Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply Chain Management:-Manage coordination with End-to-End Product Supply… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …assesses updates and impact.Key Relationships: establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels ... cGMP manufacturing and project planning experience preferred.Provide technical expertise of Change Control process as well as oversight of the MES team to ensure… more
- Compass Group (Boston, MA)
- We are hiring immediately for a full time QUALITY CONTROL COORDINATOR position. Location : Boston Medical Center - 751 Albany Street, Boston, MA 02118 Note: online ... work and clocked in properly; documents late or absent employees. Resolves internal /external guest complaints to ensure guest satisfaction. Documents call offs, and… more
- CRH (Kasota, MN)
- …to inspect, sample, and test aggregates for the purpose of quality control . Sample and test aggregates for compliance with contract specifications and quality ... control tolerance. Monitor and test process functions and materials...years in age or older. Must pass pre-employment physical, drug screen and criminal background check. Must have strict… more
- Ultragenyx Pharmaceutical (Bedford, MA)
- …templates including batch records, SOPs, OJTs and logbooks. Completion of change control forms and Deviations, plus subsequent implementation of changes and follow ... expert for all "assigned" equipment in the area of control . Identify and drive any Continuous Improvements to the...housekeeping are adhered to at all times. Participate in internal /regulatory audits as required. Attend project and other meetings… more
- Bosch Group (Washington, DC)
- …(including Executive Orders, EAR, OFAC and ITAR) and changes to US (re) export control and sanctions laws and regulations and assessing their impact on the business ... strongly contribute to the conceptual design and further development of the re-export control law process landscape at Bosch Group and its subsidiaries with focus on… more
