- Merck & Co. (Rahway, NJ)
- …development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that ... tools, and predictive approaches to inform molecule, formulation, and process selection . In summary, our team enables the translation of preclinical candidates… more
- Merck & Co. (North Wales, PA)
- …may develop, specialized methodology to project program/study milestones, create site selection criteria, and establish need for patient recruitment and retention ... organization strategies and tactics that will be used for identification, qualification, selection and preparation of sites and for recruitment and retention of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(or have subordinates) integrated CMC product level strategy (manufacturing site selection for internal vs. external manufacturing and CDMO selection , ... exit activity plan, etc.) based on a cross-functionally designed strategy, during (end-to-end) product life cycle.Develop (or have subordinates develop) activity plan, and budget for project in alignment with Unit strategy, plan, budget and CDP. Lead (or have… more
- Twist BioScience (South San Francisco, CA)
- …(Greenhouse) as the source of truth for all things related to the recruiting/ selection process.Partner with hiring managers to understand the specific needs of the ... G-Suite and Applicant Tracking SystemsExperience managing/rolling out programs to improve the selection processMust be customer focused and can provide a high touch… more
- Merck & Co. (Rahway, NJ)
- …development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that ... tools, and predictive approaches to inform molecule, formulation and process selection . In summary, our team enables the translation of preclinical candidates… more
- Aequor (PA)
- …promote our employer brand, internship programs, and career opportunities. Lead the selection and evaluation process for candidates, ensuring a fair and inclusive ... selection process. Track and analyze recruitment metrics to measure the effectiveness of campus recruitment strategies and identify areas for improvement. Stay… more
- Genmab (Plainsboro, NJ)
- …operational plans, manuals, and charters for the trialOversee the vendor selection processInitiate and verify the accuracy and completeness of initial Work ... Orders (WO) and Change Orders (CO)Guide the country selection processCoordinate responses to IEC/IRB commentsMonitor major protocol deviations (PDs) and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides information and insights to the lines of business Develops supplier selection criteria and facilitate team members through a disciplined strategic sourcing ... with suppliers to ensure optimal relationship with respect to product selection and delivery performance Establishes, directs and leads cross-functional teams in… more
- Merck & Co. (North Wales, PA)
- …(eg, data management-deliverables, trial level plans/timelines, country/site selection , site materials, system updates,-investigatormeeting planning, communication ... plans, preparation of status update reports, study close out-activities).Leads team for timeline management, risk identification and mitigation, issue resolution.May facilitate and collaborate with key internal/external stakeholders (eg, study team,… more
- Merck & Co. (Rahway, NJ)
- …verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans. Ensures measurement ... systems analysis (MSA's) for all finished product performance test methods as needed in tech transfer or lifecycle.Additional familiarity/experience with the following knowledge is a plus:21 CFR Part 421 CFR 211FDA Guidance for Industry, Container Closure… more
- Merck & Co. (Rahway, NJ)
- …early feasibility/development studies to determine viability and inform on technology selection and development strategies. This includes, but not limited to, design ... for manufacture/function analysis, preliminary supply chain development, and supplier risk assessment(s). This includes significantly workCollaborate with cross-functional teams to translate these technological insights into an actionable preliminary… more
- Merck & Co. (Rahway, NJ)
- …maintains an optimal agency roster in partnership with Procurement, ensuring selection of agencies that align with organizational goals and valuesLeads relationship ... during negotiations for value-based contracts with top Agency of Record (AoR) partners to maximize mutual benefits and performanceEffectively, accurately, and consistently records details of partnering calls, presentations, proposals, closed deals, and related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection process in collaboration with the study team and outsourcing procurement ... management.Lead the creation of the CRO scope of work in collaboration with Outsourcing Procurement Management.Lead trial feasibility and site identification activities in collaboration with the CRO and the study team. Oversee the site qualification… more
- Merck & Co. (Rahway, NJ)
- …analytical tools, and predictive approaches to inform molecule, formulation, and process selection . -We are seeking a motivated engineer / scientist to work ... collaboratively in a team environment to help solve key challenges in formulation development and manufacturing of parenteral pharmaceutical products. -The successful candidate will be a passionate scientist with strong academic fundamentals and a drive to… more
- Merck & Co. (Rahway, NJ)
- …ideas, but also have pragmatic approach to development options, technology selection and regulatory postureDemonstrated ability to identify, mitigate and clearly ... articulate program risks -Preferred Experience and Skills:Hands-on experience with physiologically-based pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product… more
- Merck & Co. (Rahway, NJ)
- …with line of sight to robust supply, pre-validation, and validation for a selection of portfolio projects and provide supply support. As the early-stage Research & ... Development Division led portfolio progresses to late-stage projects, the incumbent is expected to help transition characterization work execution/management to CCT ownership.The incumbent is expected to quickly develop and provide scientific expertise in… more
- Merck & Co. (Rahway, NJ)
- …drug-device combination product development programs ranging from concept generation/ selection , development, verification, and validation to launch readiness:Lead ... the cross-functional Device Working Groups to ensure full integration of the device development activities with the clinical, regulatory, formulation, commercial and other key Ofunctions.Lead the Device Development Engineering Core teams focused on development… more
- Merck & Co. (Durham, NC)
- …testing of vaccine products Participate in the equipment specification, selection /procurement, and qualification phases of new equipment Author, review, and/or ... edit technical documents to support regulatory filings including technical reports and risk assessments Author or approve Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes. Managing… more
- Merck & Co. (South San Francisco, CA)
- …teams to enable early, efficient, and successful decisions about PK/PD, modality selection , and dose prediction across all therapeutic areas for small molecule, ... peptide, and protein therapeutics.The Translational PK/PD Associate Director serve as an individual contributor, with the following responsibilities: Serve as expert representative for PDMB in cross-functional teams, to advance model-informed drug discovery… more
- Merck & Co. (South San Francisco, CA)
- …teams to enable early, efficient, and successful decisions about PK/PD, modality selection , and dose prediction across all therapeutic areas for small molecule, ... peptide, and protein therapeutics. The Translational PK/PD Director will serve as an individual contributor and mentor/supervise junior colleagues, with the following responsibilities: Serve as expert representative for PDMB in cross-functional teams, to… more
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