- Merck & Co. (Rahway, NJ)
- …& Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... with subject-matter experts on the DPPD team and members of internal cross-functional product development teams from concept through product launch.- Additionally,… more
- Aequor (Thousand Oaks, CA)
- …can support core hours. This will be an office based role, utilized for quality control of the instruments the Scientists are using. We are looking for a candidate ... with skills to support the quality control /review of nonclinical scientific reports. Title: Associate Research Operations,...the scientific staff in TS&BA and the Pharmacokinetic and Drug Metabolism (PKDM) groups. This role will provide oversight… more
- Merck & Co. (Rahway, NJ)
- …environment that provides substantial technical responsibility and leadership of internal and external work.The Principal Scientist, Engineering position leverages ... their expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales. --The successful candidate will play a… more
- Tris Pharma (Monmouth Junction, NJ)
- …Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.The incumbent uses ... and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and quality and regulatory requirements important to pharmaceutical and combination drug manufacturing labs.Help with plant audit ready status efforts for assigned ... areas and participate in internal and external audits as SME for department and...precautions and hazardous and biohazardous chemical handling.Knowledge of change control practices for major equipment, important systems, instrumentation, and… more
- Merck & Co. (Rahway, NJ)
- …Lab Lead advocates technical growth opportunities through collaboration with internal resources and academic or industrial partnerships.- In partnership with ... support pilot plant operations, and interface with cross-functional colleagues/customers in drug substance, drug product, and material science. Mentoring… more
- Merck & Co. (Rahway, NJ)
- …DescriptionAs part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences ... generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Successfully support the implementation, execution, and improvement of the internal audit process.Support the planning and execution of internal ... and follow-through to ensure satisfactory resolution and closure of each internal audit.Coordinate front room/ back room activities for health authority audits… more
- Insmed Incorporated (San Diego, CA)
- …for transfer of research bioassays into the CMC space prior to elevation of a drug candidate to CMC development status. They will collaborate with R&D and lead cell ... Mechanism of Action potency assay is introduced into the control system prior to BLA submission. They will be...evaluating selecting the appropriate cell line(s), based on the drug product MoA. They will be involved in engineering… more
- Merck & Co. (Rahway, NJ)
- …within our company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our company's biologics pipeline. We work ... solutions that achieve quality by design targets with robust control strategies.Advancing the upstream platform processes through creative process improvement… more
- Merck & Co. (Rahway, NJ)
- …such as residual and PCR-based assays.Strong background in analytical control strategy development and execution.Demonstrated ability to develop talent through ... assay optimization and documentation to meet program deadlines.Authoring and reviewing internal technical reports, sections of regulatory filings (eg, IND, BLA) and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Quality driven initiatives related to facilities work such as change control , deviation, and corrective actions.Ensure collaboration with key stakeholders and ... / GMP facility experience preferred.An ability to build strong partnerships with internal customers and effectively integrate with external vendors to drive facility… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Sterility Assurance Technician is responsible for working to maintain the Contamination Control Strategy for Exela Pharma Sciences, LLC. This individual should be ... maintain sterility assurance of aseptically filled and terminally sterilized drug products.Job ResponsibilitiesAssist with implementation of continuous improvement initiatives… more
- Merck & Co. (Rahway, NJ)
- …while developing and applying -strategies related to downstream processing for drug candidates in both early and late-stage development.Responsibilities include, but ... conference participation.Represent BPR&D as a downstream bioprocess expert/co-leader in internal and cross-functional project teams.Supervise, coach, and develop talent… 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
- Merck & Co. (Rahway, NJ)
- …within our company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our company's biologics pipeline. We work ... work in a matrixed team environment and collaborate with both internal and external partners including vendorsKnowledge of biologics CMC development… 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
- Aequor (Devers, TX)
- …across the Devens campus. This may include Commercial and/or Clinical drug substance manufacturing, support of Site Engineering (Maintenance and Metrology ... activities), Supply Chain/Warehouse, Laboratories (Quality Control and Process Development), or Cell Therapy Manufacturing.Act as a key contact for internal … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal ... company, with five (5) years of direct QA experience Experience in a licensed drug or biologic facility regulated by the FDA, EMEA or a leading international… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and assessment of the impact of different statistical methods for RWE/external control arm (ECA), AI/ML including generative AI/LLM using Real-World Data, and ... potential development, optimization and validation of methods used in the drug development cycle. Data Analysiso Apply statistical techniques to analyze data sets… more
