- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to communicate the issues and support resolution development.Support IRT design for control of drug dispensing and inventory management. Understand User ... playing a supportive role in ensuring adherence to Project objectives, budget control and departmental collaborations. Work is escalated if outside of scope of… more
- Aequor (Thousand Oaks, CA)
- …requirements? Knowledge of analytical techniques used for protein molecule product quality control ? Understanding of drug substance and drug product ... with PQ staff and executive leadership, International Quality, Quality Control , Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance,… more
- Baylor Scott & White Health (Grapevine, TX)
- …factors. Protects patients and employees by adhering to safety requirements, infection- control , drug and radiation policies, protocols and techniques. Uses ... proper sterile techniques when setting up and performing invasive multimodality procedures and maintains hand hygiene requirements. Maintains equipment and work area to meet quality and cleanliness standards. Works with engineers and physicists to ensure… more
- Baylor Scott & White Health (Dallas, TX)
- …factors. Protects patients and employees by adhering to safety requirements, infection- control , drug and radiation policies, protocols and techniques. Uses ... proper sterile techniques when setting up and performing invasive multimodality procedures and maintains hand hygiene requirements. Maintains equipment and work area to meet quality and cleanliness standards. Works with engineers and physicists to ensure… more
- Merck & Co. (Durham, NC)
- …patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, ... product inspection, and quality control laboratories. The Quality Assurance Specialist will support this...the position includes all aspects of Quality oversight for drug product, drug substance, media preparation, and… more
- Merck & Co. (Rahway, NJ)
- …company's Device Development (DD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... development; manufacturing process development, qualification, and validation; and, design control and risk management techniques to positively support and influence… more
- Aequor (Seattle, WA)
- …Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development. Familiarity with alliance management Job Description The ... or the development portfolio as a whole, with a particular focus on Drug Product Process Development support and alliance management. The Technical PM will work… more
- Merck & Co. (Rahway, NJ)
- …a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... (SSO): - The SSO uses an Emerson DeltaV Distributed Control System.- The SSO is a Good Manufacturing Practice...to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for… more
- Aequor (Seattle, WA)
- …position also manages post-transfer life cycle activities to support Cell Therapy Drug Product Programs. Other accountabilities might be included for the same role ... of method lifecycle and method maintenance programs to support cell therapy methods ( drug product or as applicable). End to end management for method transfer &… more
- Lundbeck (Bothell, WA)
- …of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our ... programs with a focus on methods to determine the potency of drug product for early through late-stage clinical development programs. The successful candidate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of results with supervision. This position contributes to specific aspects of drug development plans with supervision and contributes to documents submitted to ... works closely with statistical programmers in statistical analyses execution, quality control , and data derivation; collaborates closely with data manager to ensure… more
- Merck & Co. (Durham, NC)
- …Always.The Associate Director, Engineering/Maintenance will support a new drug substance manufacturing operation's engineering, maintenance, and calibration ... MANAGEMENT Responsible for major equipment-related projects, including funding, change control and equipment qualification within their areaResponsible for obtaining… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …data and documentation generated from the Environmental Monitoring program, drug product and intermediates testing from the manufacturing facility utilized ... approve relevant QC documents, logbooks, SOP's and WI's. Ensure microbiological control strategy is consistent with cGMP requirements. Participate in training and… more
- Merck & Co. (Rahway, NJ)
- …partnering with team leaders to develop strategies, plan and execute our Company's drug and vaccine development and in-line portfolio efforts. - You will partner ... requirements. Gain insight to critical project management skills used in drug development through assisting in ensuring project schedules and risk management… more
- Catalent (Harman, WV)
- …Warehouse will lead a shift consisting of Warehouse Materials Control Associates and Materials Services Associates. Responsibilities include: project participation, ... technology, material availability, procurement, logistics, operational compliance, and inventory control .Assist in developing a site master plan and roadmap for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an exempt level position responsible for reviewing all data produced by the Quality Control Lab during In-Process and release Drug Product QC Testing, related to ... a biological and/or pharmaceutical industry is required. Experience in a Quality Control setting is preferred. Knowledge of cGMP and GDP regulations and FDA/EU… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …RWE studies such as early economic models, burden of illness studies, external control arms to support single arm trials, and drive the development, analysis, and ... strongly preferred- Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including clinical,… 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 ... precautions and hazardous and biohazardous chemical handling.Knowledge of change control practices for major equipment, important systems, instrumentation, and… more
- Aequor (Thousand Oaks, CA)
- …with diverse functional areas including Supply Chain, Manufacturing, Quality Control , Regulatory, Quality Assurance, Quality Engineering, International Quality and ... and reports Execute transactions in relevant GMP computer-based systems (change control , LIMS, etc.) Adeptly manage time-sensitive activities independently Win What… more
- Catalent (Philadelphia, PA)
- …to, good manufacturing practice/quality system requirements of the Food and Drug Administration, state boards of pharmacy, European, South American, Japanese, and ... Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control , and Customer relations.The Role: Provides direction and guidance to the… more
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