- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Principal Scientist, Process Control and Data Analytics will be responsible for leading a team focused on developing and implementing product ... control strategies, statistical analysis, and advanced statistical methods for...a team of subject matter experts focusing on product control strategies, statistical analysis, and advanced statistical methods, including… more
- Merck & Co. (Rahway, NJ)
- …of DCT deliverables including - robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust ... experience, a Master's degree (MS) with 12 years of relevant experience, or PhD with 10 years relevant experienceMust have expertise in ADC development and… more
- Merck & Co. (Rahway, NJ)
- …modeling, CFD modeling, mathematical and statistical modeling of process control and characterization, and advanced process control .Collaborate closely ... Sciences, Chemical Engineering, Mechanical Engineering, Materials Science and Engineering, Control or Computer Engineering or other relevant background.Required Experience… more
- Merck & Co. (Rahway, NJ)
- …be expected to apply his/her knowledge of product development and design control principles to positively support and influence clinical and commercial combination ... degree in one of the above disciplines plus 7 years related experience OR a PhD in one of the above disciplines plus 5 years related experienceExperience with the… more
- Merck & Co. (Durham, NC)
- …-Responsible for major equipment related projects, including funding, change control and equipment qualification within their areaResponsible for obtaining bids, ... Discipline (6 Years with a master's degree or MBA: 3 years with a PhD ), or relevant military service (US Navy, US Army, US Marine Corps, US Air… more
- Merck & Co. (Rahway, NJ)
- …solutions that achieve quality by design targets with robust control strategies.Advancing the upstream platform processes through creative process improvement ... and advanced in situ analytics for process monitoring and control .Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch… more
- Formation Bio (New York, NY)
- …chemistry, or a related scientific discipline. Advanced degree (eg, Master's or PhD ) is preferred. Extensive experience (+12 years) in quality assurance roles within ... implementing, and managing pharmaceutical quality management systems, including document control , training management, change control , corrective action… more
- Merck & Co. (Rahway, NJ)
- …such as residual and PCR-based assays.Strong background in analytical control strategy development and execution.Demonstrated ability to develop talent through ... good mentoring skills.Demonstrated ability for taking initiative, creativity, and innovation in problem solving.Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis… more
- Merck & Co. (Rahway, NJ)
- …development and chemistryHigh-throughput experimentation, automation, and process control .Knowledge of microbial fermentationCell culture predictive modeling (omics ... (transcriptomics, metabolomics, or/and proteomics), metabolic flux analysis); statistics, data-science, machine learning, artificial intelligence#BPRD #PRDCurrent Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our… more
- Merck & Co. (Rahway, NJ)
- …using automation platforms such as TECANExperience using and/or programming process control systems such as DeltaV and PCS 7Experience with integrated and ... continuous processing and equipment including multi-column chromatography systems (BioSMB, PCC, or similar)Background or experience in data science approaches related to downstream processes and predictive modeling (multivariate data analysis, machine… more
- Merck & Co. (Rahway, NJ)
- …for delivering world class outcomes in the following areas:Deliver integrated control strategy and process design elements including process characterization and ... a Master's degree (MS) with 12 years of relevant experience, or PhD with 10 years relevant experienceRequired Experience and Skills:Must have expertise and… more
- Merck & Co. (Rahway, NJ)
- …10 years with BS, 8 years with MS, or 4 years with PhD .Required Experience and Skills: Technical expertise in purification of biological (including complex ... (JMP or Design Expert software).Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT)… more
- Merck & Co. (Rahway, NJ)
- …support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions such as ... BLAs, INDs, or other regulatory source documentationAbility to work effectively in cross-functional and matrixed team environment; collaborate with both internal and external partners including vendorsPossesses outstanding communication skillsAbility to coach… more
- Merck & Co. (Rahway, NJ)
- …and advanced in situ analytics for process monitoring and control .Expertise in media development, media/solution chemistry.Background in data science approaches ... related to cell culture and predictive modeling eg, metabolic flux analysis (MFA), omics, machine learning; experience integrating PAT efforts) and computational fluid dynamics (CFD).Experience leading cross functional, program development teams.Current… more
- Merck & Co. (South San Francisco, CA)
- …statistical hypothesis testing, and biological interpretationExperience in version control environments such as GitProficient in working with high-performance ... Linux clusters and cloud computing environments#EligibleforERP-Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process… more
- Merck & Co. (Rahway, NJ)
- …technologies - High - throughput experimentation, automation, and process control - Knowledge of protein expression, analytics, conjugation chemistry and ... formulation - Biophysical, mechanistic and facility modeling; statistical analysis, data-science, machine learning, artificial intelligence - - #BPRD #PRD - - - - - - - - - - - - Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto… more
- BioAgilytix (Durham, NC)
- …you'll be right at home here at BioAgilytix.Essential ResponsibilitiesPerform Quality Control (QC) technical, scientific, and compliance review of data and ... biotech, pharmaceutical, CRO/CMO or similar organization; or Master's or PhD . with equivalent experienceKnowledge and/or extensive knowledge of GxP… more
- Aequor (Framingham, MA)
- …factories of the future, and advanced analytics-based process understanding and control .RESPONSIBILITIES: Work with a global group of engineers and scientists to ... develop robust and scalable downstream processes for monoclonal antibodies, bispecific antibodies, Fc-, Fab-, and fusion proteins, enzymes, and other recombinant proteins to support GMP manufacture. Manage an MSAT development team, including regular team… more
- Formation Bio (New York, NY)
- …and governance, holding external partners to high standards of quality, cost control , and on-time deliverables. Serve as the Operations Lead for clinical assets, ... Ability to travel as required (up to 25%). Preferred: Advanced degree (eg, MSc, PhD , MBA) in a related field. Formation Bio is headquartered in New York City,… more
- Formation Bio (New York, NY)
- …are seeking a highly motivated and detail-oriented Analytical Development and Quality Control biologics expert to join our CMC team. The ideal candidate will ... play a key role in providing technical leadership for the development, optimization, and validation of drug substance and drug product analytical methods to support the development and manufacturing of large molecules including but not limited to proteins,… more
