- Aequor (Pearl River, LA)
- …Substance in the downstream processing (Clarification and Purification) and buffer preparation areas of the cGMP commercial manufacturing facility. Requires good ... steam-in-place of process equipment. Other duties will include the cleaning and preparation of workspaces and biosafety cabinets. The incumbent should be proficient… more
- Merck & Co. (Millsboro, DE)
- …to approved proceduresAssist with performing aseptic procedures including media preparation , antigen inoculation and harvest, tissue culture preparation ... Culture, Manufacturing Documentation, Manufacturing Operations, Manufacturing Quality Control, Media Preparation , Process Improvements, Regulatory Compliance, Safety Practices, Science, Standard… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, ... (eg, preIND, EOP2, pre-NDA, Type C, Scientific Advice) with supervision, from preparation of the briefing book, to training and preparing the technical team,… more
- BioAgilytix (Durham, NC)
- …all aspects of bioanalytical studies-including project scope definition, proposal preparation , timelines, scheduling, budget, and revenue management. This role is ... aspects of bioanalytical studies including project scope definition, proposal preparation , timelines, scheduling, budget, and revenue management.Act as primary… more
- Aequor (Tampa, FL)
- …local and international tax laws. Tax Provision and Reporting Support the preparation of ASC 740 tax provisions for Latin American jurisdictions, ensuring precise ... ensure compliance and accuracy. Forecasting and Cash Flow Support the forecast preparation to determine tax payments annual estimations. Prepare and supervise tax… more
- Eisai, Inc (Exton, PA)
- …suites in a cGMP biopharmaceutical pilot plant, including scheduling of staff, preparation and close-out of documentation, manufacture of DS/ADI materials, and suite ... production schedules. Be responsible for the scheduling of staff and facility, preparation and close-out of documentation, and maintenance of the facility and… more
- Merck & Co. (Upper Gwynedd, PA)
- …in accordance with global regulations and guidances, and is-responsible for the preparation and submission of CMC dossiers for all assigned development products. ... Skills: The ideal candidate will have experience in Regulatory CMC or in preparation of regulatory filings with technical leadership skills, as well as demonstrated… more
- Merck & Co. (Rahway, NJ)
- …Detail-Oriented, Law Office Administration, Legal Compliance, Legal Documents Preparation , Legal Operations, Legal Research, Legal Services, Legal Strategies, ... Automation, Supplier Management, Team Leadership, Training and Development, Trial Preparation , Vendor Contract Negotiations, Vendor Management, Vendor Management Systems… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on and authors SOPS, SOIs, and process guides. Participates in inspection preparation activities and internal and external audits and audits CAPA preparation ... .Case Processing Training: Identifies case processing and related CRO/vendor training needs and reviews case processing project specific training materials. Manages and coaches the PV Vendor Training Coordinator. Qualifications: Successful candidates will be… more
- Merck & Co. (Rahway, NJ)
- …Loan Processing, Loan Underwriting, Management Process, Mutual Fund Operations, Preparation of Financial Reports, Team Leadership-Preferred Skills:Job Posting End ... Date:08/29/2025 *A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R356057 more
- Merck & Co. (Durham, NC)
- …monitoring, aseptic process simulation and support testing readiness in preparation for commercial production.- The selected candidate will participate in ... equipment validation, process validation, and GMP laboratory readiness.- The Quality Operations Laboratory Specialist performs laboratory testing on a variety of product samples and media. The selected candidate will also be expected to review and authorize… more
- Merck & Co. (Rahway, NJ)
- …and other project stakeholders. Primary Activities: PreNDA and PreBLA meeting preparation , study data standards plan, preparing questions for FDA e-data mailboxes ... (CBER/CDER), attendance at meetings with regulatory agencies (FDA, EMA, PMDA),Guiding project teams preparing submission deliverables including use of Pinnacle 21 Enterprise,Up-versioning activities to specific versions of SDTMDevelop SAS Macros and Python… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the creation of contingency/backup plans for CDx submission. Health Authority Submission Preparation : Assist with preparation of pre-submission documents and ... CDx related portions of therapeutic marketing applications and respond to regulatory queries/feedback from HAs. Contribute to providing timely feedback for Dx Partners to address regulatory questions from Global Health Authorizes (HAs) during review of device… more
- Aequor (Tampa, FL)
- …products. Support QC chemist to provide the method technology transfer and project preparation work, make sure the project runs on time and smoothly. Key ... Accountabilities Performs, analyzes, and interprets QC and microbial limits testing according to USP and regulatory requirements for raw materials, finished products, and stability samples. Perform environmental monitoring which includes water sampling and… more
- Merck & Co. (North Wales, PA)
- …site materials, system updates, investigator-meeting 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, country teams, vendors, committees) in support of clinical study objectives.Accountable… more
- Merck & Co. (Rahway, NJ)
- …the Clinical Supplies section of the study protocol as well as preparation and presentation of the clinical supplies information at Investigator Meetings for ... assigned protocols. - Support the collection of clinical suppl y chain metrics and/or participate in critical non-pipeline activities. - Participate in Interactive Voice Response (IVR) System d evelopment and User Acceptance Testing (UAT) for assigned studies… more
- Aequor (Athens, GA)
- …may include aseptic filling of vials under sterile conditions, vial preparation and sterilization, capping of vials under non-sterile conditions, and general ... support activities related to filling. Operates general manufacturing equipment in strict accordance with SOPs to complete tasks as noted above. Brings deviations in process protocols to supervisors attention. Maintains all associated documentation for… more
- Twist BioScience (South San Francisco, CA)
- …primer design)Hands-on experience with NGS and NGS applications (eg library preparation , target enrichment, sequencing and sequencing data analysis)High attention to ... detail. Ability to identify problems and use a combination of knowledge, intuition, and experience to solve problems in a timely mannerSelf-motivated and passionate about your workExcellent interdisciplinary communication skills requiredWilling and able to… more
- Merck & Co. (Minneapolis, MN)
- …conveying the value and benefits of our Company's Animal Health portfolio through: Preparation and delivery of technical lectures on our product line to key ... customers, strategic accounts, and professional veterinary organizationsOffering solutions that align with customer needs and business prioritiesPartner with Regional Sales Manager to develop and execute effective business strategy to reach and exceed regional… more
- Merck & Co. (Rahway, NJ)
- …Director of Launch Strategy and Operations, you will lead the enterprise preparation of multiple product launches in Immunology. You will collaborate closely with ... marketing leadership, as well as partner with cross-functional teams to develop and implement strategic launch plans, ensuring market readiness and optimizing commercial success. This role requires a blend of strategic thinking, operational excellence, and… more
