- Merck & Co. (Rahway, NJ)
- …in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide ... troubleshooting and people management.Serve as the scientific/technical mentor for junior staff .- Provide technical guidance in the various aspects of Cell Culture… more
- Formation Bio (New York, NY)
- …is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses… more
- Merck & Co. (Rahway, NJ)
- …team is responsible for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates and Small Molecules, including ... to commercial scale, step across boundaries and implement novel innovations during drug product development to enable best science at first filing for parenteral… more
- Merck & Co. (Rahway, NJ)
- …developing, and scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the benchtop to current Good Manufacturing Practice ... manufacturing facilities, our scientists use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients.The Director… more
- Merck & Co. (Rahway, NJ)
- …Our Team as an Associate Principal Scientist/Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a significant impact in ... forefront of innovation in the-Manufacturing Division, specifically within the-Biologics Drug Substance Commercialization (BDSC) team. Our Downstream Purification-department is… more
- Merck & Co. (Rahway, NJ)
- …accountable for establishing the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . - Works directly in the SAP system ... s used within the assigned program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug ...of expertise. - Mentors new team members and supports staff development, as needed. D emonstrates high capability to… more
- Merck & Co. (Rahway, NJ)
- …(FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply ... GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will leverage leadership skills in strategic… more
- Eisai, Inc (Exton, PA)
- …focused on the technology transfer, scale-up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug Intermediate (ADI) production ... individual performance and cost center budgets. The individual recruits staff as necessary and mentors, coaches, and develops ...staff as necessary and mentors, coaches, and develops staff to maximize individual potential and to grow and… more
- Merck & Co. (Boston, MA)
- …for all TK-related issues pertinent to the development of assigned drug candidates and closely interact with toxicology study directors, project representatives, ... bioanalytical scientists, drug metabolism and translational modeling representatives, and other relevant functional areas.Serve as a contributing scientist on… more
- Merck & Co. (Rahway, NJ)
- …and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and ... technical staff to support global and site-specific projects, facilitate technology...stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and… more
- Merck & Co. (Durham, NC)
- …role will contribute to the performance and results of a E2E drug substance/product department and provide technical guidance. Off-shift and weekend coverage will ... is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are not limited to… more
- Merck & Co. (Rahway, NJ)
- …and Skills:20+ years of deep and broad expertise in GMP biologics drug substance and sterile drug product manufacturingExperience across multiple biologic ... Cross-Functional Team Leadership, Empathy, Feasibility Studies, Management Process, Mentoring Staff , Performance Monitoring, Personal Initiative, Project Scheduling, Resource Allocation,… more
- Merck & Co. (Rahway, NJ)
- …:Develops, coordinates, and provides biostatistical support for related drug /vaccine projects under supervision in Late Development Statistics. --Interacts ... clinical trials, and in coordinating the statistical activities for clinical drug /vaccine projects.The incumbent may initially work in a specific disease therapeutic… more
- Merck & Co. (North Wales, PA)
- …trial projects; and may lead a group of statistical or programming staff assigned to a development project as needed. More specifically,-Develops, coordinates, and ... provides biostatistical support for drug projects under the supervision of management.-Lead a team...projects under the supervision of management.-Lead a team of staff assigned to the project as needed.-This includes the… more
- Merck & Co. (Rahway, NJ)
- …studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug ... for planning and management of an important inflection point in the drug development process, working closely with scientific, regulatory, statistical, and modelling… more
- Insmed Incorporated (San Diego, CA)
- …Development Team representative as an Analytical Lead for a drug program.Key Responsibilities:Responsibilities include developing and optimizing analytical methods ... various spectroscopic equipment. This involves assessing properties of AAV drug candidates and troubleshooting technical issues. Contributes to method qualification… more
- City of Hope (Monrovia, CA)
- …diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches ... and curing diseases, shaping the future of medicine through cutting-edge research. A Staff Scientist position is available in Beckman Research Institute of City of… more
- Merck & Co. (Rahway, NJ)
- …an experienced leader who will manage a team of scientists to support drug substance process development activities to enable and accelerate early and late-stage ... direct reports while effectively interacting with other teams within BPD and staff in Process Cell Science, US Operations, Clinical Manufacturing, and Commercial… more
- Aequor (Thousand Oaks, CA)
- …strive to serve every patient, every time. In this critical role for the Thousand Oaks Drug Product (DP) facility, - also known as ATO B20 - you will be responsible ... and/or indirect people management / leadership experience Understanding of Drug Product Formulation and Vial/Syringe Filling operations Experience with various… more
- Aequor (Thousand Oaks, CA)
- …program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas. Under general supervision, the role provides support and ... compliance oversight to Manufacturing and Facilities & Engineering areas/ staff in the execution of their processes, procedures, and use of quality systems. Duties… more