- Merck & Co. (Rahway, NJ)
- …responsible for device design control activities in the following aspects: Lead and contribute device development design controls for the assigned projects.- ... Job DescriptionJob Description The Senior Scientist, Device Design Control Lead , is a crucial member...and apply regulatory / compliance requirements relative to design controls and risk management activities. Contribute to… more
- Merck & Co. (North Wales, PA)
- …teams to deliver projects and products that improve human health and business .- -Under GPAM, the CMC Integrated Project Management (CIPM) organization supports ... the guidance of the CIPM Staff Manager & Portfolio Lead , the core responsibility of this senior Project Manager...will be to manage CMC programs, due diligence and business development activities independently, regardless of complexity, phase or… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionApplications are sought for a Process Engineering Lead position in o ur Reseach & Development Division Biologics Process Research & Development ... building a collaborative network, and will require agility and flexibility to meet business needs.As leader of the Process Engineering group, the incumbent will be… more
- Merck & Co. (Durham, NC)
- …technical business processes including:- technical documentation, change control , portfolio management, risk mitigation, deviation management, technical ... cross-site issues, identify trends and participate in proactively implementing risk mitigation actions.Collaborate with functional teams to contribute to strategic… more
- Merck & Co. (Durham, NC)
- …technical business processes such as:- technical documentntation, change control , portfolio management, risk mitigation, deviation management, technical ... issues, help identify trends, and participate in the implementation of risk mitigation actions.Collaborate with functional teams to contribute to strategic… more
- Merck & Co. (Rahway, NJ)
- …equipment, as well as qualification and validation, medical device design controls and device risk management, and design verification/ validation.Demonstrated ... and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible for technical leadership of key… more
- Merck & Co. (Rahway, NJ)
- …Expertise: Utilize extensive experience in design controls , device transfer, control strategies device risk management, and design verification testing to ... syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to...syringes, and complex drug delivery systems.Proven expertise in design controls , risk analysis, control strategies,… more
- Merck & Co. (Rahway, NJ)
- …equipment, as well as qualification and validation, medical device design controls and device risk management, and design verification/ validation.Demonstrated ... cross-modality technical team. As an individual contributor, the associate director will lead cross functional teams.- The leader will be responsible for executing… more
- Merck & Co. (Rahway, NJ)
- …Responsibilities:Utilize extensive experience in design controls , device transfer, control strategies, device risk management, and design verification ... expert on the device components and combination products and lead a cross functional team members to support global...in managing external partners and suppliers.Proven expertise in design controls , risk analysis, control strategies,… more
- Merck & Co. (Rahway, NJ)
- …and leadership skills, including conflict resolution expertise and discretion.Ability to lead cross-functional teams of business professionals within and outside ... Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM...`quality by design` within clinical development programs, using a risk -based approach.The incumbent will be accountable for the overall… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …escalation and the CAPA Management Process for the respective business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality ... monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process… more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... on the analysis of inputs, outcomes, risks, and company-wide prioritization.Essential Responsibilities: Lead , mentor, and develop a team of technical staff, fostering… more
- Merck & Co. (North Wales, PA)
- …Responsibilities:The engineer will be responsible to leverage their scientific, technical, and business expertise to participate or lead in capital equipment ... processes including packaging equipment design & development, ensuring packaging process control and efficiency and providing on-going packaging and device technical… more
- Merck & Co. (Rahway, NJ)
- …environment.Recognition:-Celebrate team achievements and foster a culture of appreciation.Innovation:- Lead business improvement initiatives and leverage your ... and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process… more
- Merck & Co. (Rahway, NJ)
- …inputs, outcomes, risks, and enterprise-wide prioritization. Primary Responsibilities include: Lead a sterile product group, accountable for people and operations, ... including managing a sterile portfolio budget, business process optimization, and employee development. Provide technical direction and oversight of engineering of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... and productivity improvements.Support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support… more
- Merck & Co. (Rahway, NJ)
- …analytical technical transfer, and Biologics License Application preparation. Responsibilities Lead method transfers and/or validations across vaccine and biologics ... programs including quality risk assessments/gap analysis.Provide sponsorship of both in-line and pipeline analytical methods. The candidate will interface across our… more
- Merck & Co. (Rahway, NJ)
- …include following current Good Manufacturing Practices (cGMPs), participating in risk assessments, and Good Documentation Practices (GDPs).-In addition to supporting ... and/or the Head of the Crystallization Lab, the principal scientist may lead strategic technical initiatives and support talent development of junior engineers.A… more
- Merck & Co. (Rahway, NJ)
- …of the following: process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, ... validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Change Controls , and other product life cycle management activities.Partner with… more
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