- Novo Nordisk Inc. (Durham, NC)
- …business and regulatory requirements. Support training for lower-level peers. Demonstrate subject matter expertise in assigned area. Provide process solutions ... of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable… more
- Merck & Co. (Rahway, NJ)
- …industry experience.-Required Experience and Skills: Strong fundamental knowledge and subject matter expertise in downstream processing of biologicsExpertise ... Job DescriptionAs part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the BioSeparation Sciences (BSS)… more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutical/Biotech industry Required Experience and Skills: Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing ... Job DescriptionAs part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation… more
- Merck & Co. (Rahway, NJ)
- …products and robust manufacturing processes.-- This position interacts extensively with subject - matter experts on the DPPD team and members of internal ... expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation; and design control and risk… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …plan, data maintenance plan and security/access policy Serves as the subject matter expert (SME) of the Engineering Data Management System (EDMS) including ... depository of engineering data Provides leadership and technical subject matter expert (SME) for drawing/drafting/modeling programs including software… more
- Merck & Co. (Rahway, NJ)
- …in their respective area(s) of expertise.The Associate Director brings forward strong subject matter expertise to lead studies and evaluations, determine ... and Skills: Minimum 7 years of experience in Pharmaceutical/Biotech industry in engineering or manufacturing .5+ years engineering or operations experience… more
- Insmed Incorporated (San Diego, CA)
- …on potency assay transfer into Analytical Development.Serve as a subject - matter -expert for cell-based potency assay cell line engineering , development and ... CMC development status. They will collaborate with R&D and lead cell line engineering efforts focused on CMC bioassay development activities to ensure an appropriate… more
- Merck & Co. (Rahway, NJ)
- …quality risk management activities as facilitator, project lead and/or quality subject matter expert. Proactively identify, execute and manage independent ... the clinical supply QMS through participation as topic team member and/or subject matter expert. Represent Development Quality on inter-departmental and… more
- Aequor (Thousand Oaks, CA)
- …you will actively provide quality assurance support to the PQ organization as a subject matter expert of quality system records. In this team-based role you ... team by collaborating with diverse functional areas including Supply Chain, Manufacturing , Quality Control, Quality Assurance, Regulatory, Quality Engineering ,… more
- Merck & Co. (Durham, NC)
- …including the development and implementation of corrective actions.Over time, become a subject matter expert (SME) in specific process steps, automation ... embrace an empowered team culture including significant interaction with manufacturing , quality and engineering groups.- This position...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Merck & Co. (Durham, NC)
- …- Serves on safety, quality and other committees as required . - Serves as the subject matter expert within the processing suite and trains new team members - - ... AM - 6:30 PM rotation (2-2-3). - The Vaccine Manufacturing Facility Senior Production Technician is an excellent opportunity..., or a Bachelor's degree in Life Science or Engineering Must be willing to work 12-hour day shift… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …functional and process risk assessments in conjunction with Quality and Manufacturing subject matter expertsOversee development and execution ... of deviances and variances that occur during production or validationWork with Quality, Manufacturing , Regulatory, and subject matter experts to prepare for… more
- Merck & Co. (Durham, NC)
- …support for the facilityLeading routine process support, projects, and improvement activitiesServing as subject matter expert on the process for daily work and ... 140 countries, we offer state of the art laboratories, manufacturing plants and offices that are designed to Inspire...chest x-ray Required Experience and Skills:Bachelor degree in an Engineering or Science related field with minimum 2 years… more
- Merck & Co. (Rahway, NJ)
- …can thrive. Responsibilities include but are not limited to: Act as a subject matter expert in process development and characterization of engineered enzymes ... operations for new team members. Partner with functional area project teams and subject matter experts to establish and implement the scientific strategy for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …designs.Participate in design testing, release planning, and demos with partners.Serve as a Subject Matter Expert of MES for CAR-T and site initiatives requiring ... of multiple myeloma.Legend Biotech is seeking MES Engineer as part of the Manufacturing Excellence team based in Raritan, NJ. Role OverviewThe MES Engineer will be… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to make improvement to existing systems as needed. This role is the site Subject Matter Expert (SME) for site GMP Clean Utilities infrastructure and systems ... efficiency of operation. Responsibilities will include:Strong technical skills, be the Subject Matter Expert (SME) from equipment Utilities-HVAC systems. Deep… more
- Merck & Co. (Rahway, NJ)
- …primary activities include and are not limited to the following: Function as a Subject Matter Expert on all power generation equipment and processes.Lead power ... engineer with strong analytical and problem-solving skills to provide engineering support for our campus facilities, master planning, and...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Merck & Co. (Rahway, NJ)
- …global Technical and Quality Agreements,Participating in contractor GMP audits as a Subject Matter Expert,Conduct of contractor "deep dive" quality assessments ... and large molecule development programs.-Additional experience in drug substance manufacturing and medical device and/or combination products would be preferred.-… more
- Merck & Co. (Rahway, NJ)
- …manufacturing processes. The role requires extensive collaboration with subject - matter experts across various cross-functional combination product development ... and training programs, facilitating knowledge transfer for internal and external manufacturing sites to strengthen awareness of risk management principles across… more
- Merck & Co. (Rahway, NJ)
- …number of trials, clinical trial design and Go/No Go decisionsServe as a subject matter expert and foster collaboration within QP2 and across functions ... the above duties and to develop the above capabilitiesLeverage significant pharmacometric and subject matter expertise in a broad range of therapeutic areas,… more
