11 jobs found in New Castle, DE

Apex Systems, Inc. Job#: 3014834 Job Description: Seeking a Microbiologist to join a Biotech company in the greater Philadelphia area. POSITION SUMMARY * The Microbiologist will perform routine environmental monitoring in a cleanroom environment and characterize and trend microbial recoveries for the program to support manufacturing operations. Essential Functions: * Aseptically collect viable and non-viable samples from the manufacturing cleanrooms. * Participate in the Qualification and/or Validation of Microbiological methods and equipment. * Enumerate, isolate, and identify microbial recoveries. * Perform routine testing utilizing Microbiological Test Methods under cGMP Guidelines such as Bioburden, pH, Osmolality, and Endotoxin. * Report and participate in Out of Specification/Out of Trend Investigations. * Participate in Deviations, CAPA's, and other continuous improvement activities. * Draft/Revise SOPs, Reports and other documents using sound...

Merck Job Description The West Point Technical Operations organization within the company's Manufacturing Division is responsible for providing technical support to vaccine manufacture through technical investigations, lifecycle-management driven process enhancements, and commercial vaccine expansions. We are seeking an experienced Associate Director, Engineering to join Technical Operations in West Point, PA. The candidate will have a primary role providing manufacturing process support to our company's portfolio of live virus vaccines. The candidate will collaborate with key stakeholders to design and analyze experiments to enhance production of these vaccines and to provide technical support to the manufacturing shop floor. The candidate will additionally serve as a resource for the broader vaccine manufacturing organization as a subject matter expert (SME). The ideal candidate will have a strong background in virology, host-cell interactions, cell biology,...

Merck Job Description The Associate Principal Scientist, Device Risk Management Lead, is a crucial member of our team, responsible for spearheading risk management efforts in combination product development, commercialization, and lifecycle management. This individual will oversee device risk management activities to ensure the delivery of high-quality products and efficient manufacturing processes. The role requires extensive collaboration with subject-matter experts across various cross-functional combination product development teams throughout all phases of the product lifecycle, from concept through launch and post-market surveillance. Key Responsibilities and Activities: The Associate Principal Scientist, Device System - Device Risk Management will be responsible for device risk management activities in the following aspects: Lead and contribute to thorough risk assessments for both inline and new products, guiding projects from early design concept...

Merck Job Description The Senior Scientist, Device Risk Management Lead, is a crucial member of our team, responsible for spearheading risk management efforts in combination product development, commercialization, and lifecycle management. This individual will oversee device risk management activities to ensure the delivery of high-quality products and efficient manufacturing processes. The role requires extensive collaboration with subject-matter experts across various cross-functional combination product development teams throughout all phases of the product lifecycle, from concept through launch and post-market surveillance. Key Responsibilities and Activities: The Senior Scientist, Device System - Device Risk Management will be responsible for device risk management activities in the following aspects: Lead and contribute to thorough risk assessments for both inline and new products, guiding projects from early design concept through commercialization and...

Merck Job Description The West Point Technical Operations organization within the company's Manufacturing Division is responsible for providing technical support to vaccine manufacture through technical investigations, lifecycle-management driven process enhancements, and commercial vaccine expansions. We are seeking an experienced Associate Director, Engineering to join Technical Operations in West Point, PA. The candidate will have a primary role providing manufacturing process support to our company's portfolio of live virus vaccines. The candidate will collaborate with key stakeholders to design and analyze experiments to enhance production of these vaccines and to provide technical support to the manufacturing shop floor. The candidate will additionally serve as a resource for the broader vaccine manufacturing organization as a subject matter expert (SME). The ideal candidate will have a strong background in virology, host-cell interactions, cell biology,...

Merck Job Description Job Description: Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough. The Process Operations Specialist is responsible for leading and executing GMP bioreactor operations in support of clinical manufacturing campaigns, ensuring consistent execution of upstream processes and supporting integration with other process areas. The Specialist applies technical knowledge, problem solving and leadership skills to deliver high-quality, compliant biomanufacturing operations. Key Responsibilities: Execute GMP batch records for upstream bioreactor operations across scales ranging from benchtop to 2000L in stainless steel, glass, and...

Merck Job Description Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough. The Senior Specialist, GMP Process Operations, serves as a technical expert and operational leader within the upstream bioreactor operations team. This role is hands-on, providing both direct process execution and leadership across multiple manufacturing campaigns. The Senior Specialist applies deep technical knowledge of bioreactor systems and GMP compliance to ensure successful production of clinical materials, effective technology transfer of new processes and continuous improvement of manufacturing operations. Key Responsibilities: Lead and execute GMP bioreactor operations...

Merck Job Description We are seeking a collaborative, self-motivated Senior Scientist to join the Drug Metabolism and Pharmacokinetics (DMPK) Group within the Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) organization at our Company's Research Laboratories in West Point, PA. The main goal of this position is to support the advancement of drug candidates through characterization of absorption, distribution, metabolism, and elimination (ADME) properties of therapeutics. Successful candidates will provide enzymology expertise and independently design and execute experiments utilizing in silico, in vitro, and in vivo methodologies to assess drug disposition and drugdrug interaction risk, and contribute to decisionmaking for lead discovery and development. The role requires strong laboratory execution, data analysis and documentation skills, the ability to work across interdisciplinary project teams, and the capacity to design novel approaches to solve complex...

Merck Job Description The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) function of our Research & Development Division in West Point, Pennsylvania, is seeking a dynamic and collaborative scientist for the Drug Metabolism and Pharmacokinetics (DMPK) group. The Principal Scientist will be a key contributor to multi-disciplinary drug development and discovery efforts providing an integrated understanding of DMPK properties, pharmacokinetics/pharmacodynamics (PK/PD), and drug interaction (DDI) risk of novel therapeutics. The key responsibilities will be to work within teams of highly collaborative, cross-functional scientists to contribute to the discovery and clinical development of therapeutics across various modalities. The Principal Scientist will guide the design and interpretation of in silico, in vitro, and in vivo analyses to support the discovery of therapeutics with the desired DMPK profile. They will assess DDI risk using static mechanistic...

Merck Job Description Principal Scientist (Director) - Outcomes Research - Head & Neck cancers This position resides within our company's Value and Implementation (V&I), Outcomes Research organization, which is responsible for real-world evidence generation and outcomes research to enable sustained patient access to our company's innovations and improve patient health outcomes. Under the guidance of an Executive Director, this individual will support the V&I, Outcomes Research teams in Head & Neck cancers. Primary Responsibilities: Support the value evidence teams in head & neck cancers and lead the execution of value evidence projects in head & neck cancers for in-line and pipeline products. Provide outcomes research leadership on cross-functional regional and global teams. Critically assess drivers and barriers to reimbursement and market access in collaboration with internal teams, and provide input into clinical, payer/access,...

Merck Job Description Principal Scientist (Director) - Outcomes Research - Gastric Cancers This position resides within our company's Value and Implementation (V&I), Outcomes Research organization, which is responsible for real-world evidence generation and outcomes research to enable sustained patient access to our company's innovations and improve patient health outcomes. Under the guidance of a senior leader, this individual will support the V&I, Outcomes Research teams in Gastrointestinal Malignancies with a primary focus on gastric cancer. Primary Responsibilities: * Support the value evidence teams in gastric cancer and lead the execution of value evidence projects in gastric cancer for in-line and pipeline products. Provide outcomes research leadership on cross-functional regional and global teams. Critically assess drivers and barriers to reimbursement and market access in collaboration with internal teams, and provide input into clinical,...