Scientist - Analytical Development
By Takeda Pharmaceutical At , San Diego $105,000 - $150,000 a year
Organization - Exercise good time management and prioritization skills
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Hands-on experience with various analytical methods such as GC, LC, LC-MS/MS, etc. to support analysis
Work cross functionally to build internal capabilities.
Analytical and Problem-Solving Skills - Able to troubleshoot critical issues and instrumentation, and determine causes and possible solutions
PhD degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science with 1+ years relevant experience, or
Senior Manager, Analytical Development
By Vividion Therapeutics, Inc. At San Diego, CA, United States
Previous stability management and analytical data review experience highly desired.
Maintains up-to-date knowledge of applicable industry/regulatory guidelines/requirements.
Database administration experience and demonstrated knowledge of quality systems.
Manages or supports investigations, change controls and CAPAs as required.
Collaborates with project teams to define stability commitments for study design, testing requirements and stability specifications, as appropriate.
Remain current with regulatory and industry requirements relevant to the stability program.
Temp - Associate Scientist, Biologics Analytical Development
By Neurocrine Biosciences At San Diego, CA, United States
Executes on strategy, vision, and direction set by line management
Master's/PhD in relevant discipline and Some similar experience as noted above
Knowledge of protein and gene therapy biology with a good understanding of testing/characterization methods required
Some experience with novel methods in AAV characterization (e.g. ddPCR, DLS, AUC, NGS, CE-SDS) preferred
Good knowledge of cell-based methods associated with bioanalytical analytical method development (e.g. TCID50, Potency assay, viral transduction, and ELISA methods) preferred
Familiar level knowledge of the biologics drug development process is recommended
Scientist 2, Analytical Development Jobs
By Catalent Pharma Solutions At San Diego, CA, United States
BS with 3+ years of experience in analytical development
MS with 2+ years of experience in analytical development
PhD with 0+ years of experience in analytical development
Demonstrated experience in physical characterization techniques such as TGA, DSC, PXRD, GVS, and SEM.
Must demonstrate excellent communication, critical thinking, and organizational skills.
Physical requirements: must be able to lift up to 25lbs, walk/sit/stand on regular basis, and regular use of computers
Analytical Development Scientist - Cdmo
By CSG Talent At San Diego, CA, United States
Prepare and review technical reports, method validation protocols, and other documentation to support regulatory filings and client requirements.
Maintain and troubleshoot analytical instruments and equipment, ensuring their proper functioning and calibration to deliver accurate and precise analytical results.
Collaborate with external partners, including contract testing laboratories and clients, to coordinate analytical activities and address technical inquiries.
Familiarity with regulatory guidelines (e.g., FDA, ICH, USP) related to analytical method development, validation, and GMP compliance.
Qc Manager - Analytical
By Wacker Chemie AG At , San Diego, 92101, Ca
Strong communication skills, both written and verbal in the English language, and outstanding interpersonal skills are essential job requirements.
Knowledgeable using Microsoft Office as well as developing any documentation and creating tables for laboratory inventory and data entry.
Experience in the development and establishment of operations of QC laboratories in a GMP regulated environment.
In-depth experience related to method development, optimization, validation, and tech transfers.
Strong leadership and motivational capabilities.
Strong scientific, analytical, and problem-solving skills as well as sound judgment, to identify problems and leads efforts to resolve them.
Director, Late-Phase Analytical Cmc Lead, Biologics Analytical Operations
By BioSpace At Oceanside, CA, United States
Practical working knowledge of cGMP; capable of assessing compliance to quality requirements using sound judgment and risk management.
Serve as an analytical representative on pharmaceutical development project teams and provides comprehensive project analysis to senior management.
Must have late stage development knowledge and BLA experience.
Must be familiar with ICH regulations and FDA/EMA requirements and expectations, plus experience with health authority inspections.
Must have experience in leading a team to support analytical development and process development.
Proven experience with managing CMO/CRO relationships and projects
Scientist I/Ii, Analytical Development
By Rejuvenate Bio At San Diego, CA, United States
Perform method qualification and validation activities in compliance with relevant industry guidelines and regulations (e.g., ICH, FDA).
Perform any additional duties assigned by supervisor or manager.
Strong understanding of biophysical characterization methods, protein biochemistry, analytical techniques, and regulatory requirements for biologics.
Experience with ELISA, SDS-PAGE, Western blotting, and qPCR.
Knowledge of relevant industry guidelines and regulations (e.g., ICH, FDA) for analytical methods development and validation for biologics.
Demonstrable experience keeping pristine records of experiments and DNA constructs produced using a digital laboratory notebook.
Analytical Chemist Jobs
By Magrathea At Oakland, CA, United States
Developing benchscale techniques to enhance Magrathea's analytical capabilities.
Experience with analytical techniques such as ICP-OES, titrations, TGA, dissolved organic measurements, calibrations, and other aqueous measurements
Leading analytical chemistry experiments and workstreams in support of Magrathea's engineering team.
Supervising elemental analysis of lab samples, conducting QAQC on data collection, and analyzing experimental results to accelerate development of our technology
Contributing actively to a safety culture that puts physical wellbeing ahead of all other company priorities
Occasional travel to off-site locations where the company is developing commercial smelter operations
Director/Principal Scientist, Analytical Methods Development - Expat In Korea
By Laguna Source At Los Angeles, CA, United States
* 8+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.
* Experience contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions desired.
* Experience working on technology transfer and validation activities within cGMP compliance.
* Leading technology transfer processes and working cross functionally with Quality Control departments.
* Designing and conducting stability, impurity and degradation studies.
* Leading analytical related process characterization studies.
Analytical Chemist Jobs
By Ambient Photonics At Scotts Valley, CA, United States
Proven experience working as an Analytical Chemist, preferably in a production setting.
Strong knowledge of analytical techniques such as chromatography and spectroscopy.
Experience in method development, validation, and troubleshooting of analytical instruments.
Excellent analytical and problem-solving skills, with the ability to interpret complex data and draw meaningful conclusions.
Effective communication skills, both written and verbal, to convey technical information to diverse audiences.
Develop and validate analytical methods to ensure accuracy, precision, and reliability of results.
Analytical Scientist Ii Jobs
By Scientific Search At Hercules, CA, United States
Analysis and evaluation of material and products at all stages of development process under stringent quality and time requirements.
A minimum of 3-7 years of industrial experience with hands-on experience in analytical chemistry.
Experience with the development of bioanalytical methods is a plus.
Excellent written, reporting, and verbal communication skills.
Candidates with hands-on experience in the operation of Sciex LC/MS/MS are preferred.
Review of data for technical content and regulatory compliance.
Associate Scientist, Analytical Development, Genomics
By BioSpace At Santa Monica, CA, United States
Experience working with Python/R in bioinformatics data analysis, SQL data management, and data visualization tools such as Power BI or Tableau.
Improve the data management of analytical laboratories, ex. automation, digitalization, and data visualization.
Experience in statistical analysis to analyze complex biological datasets.
Experience working with lab automation systems, including scripting, operating, and maintenance.
Hands-on experience in nucleotide extraction, PCR and library preparation.
Hands-on experience in Bioinformatic data analysis.
Qc Analytical Scientist Jobs
By Takeda Pharmaceutical At , Thousand Oaks, Ca $64,400 - $92,000 a year
Manage and perform assay control and important reagent qualifications, including monitoring and trending of method performance.
Excellent technical writing skills and able to write create technical documents and reports that meet company and regulatory requirements.
Knowledge about analytical method validation and important reagent qualification.
Basic knowledge about regulatory requirements concerning analytical instrumentation, test methods, and licenses.
Substantial knowledge regarding regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH
Support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.
Analytical Chemist Jobs
By UCLA At , Los Angeles, Ca

ICM is seeking an analytical chemist to join its latest cutting-edge action team with the potential for carbon removal at a global scale. This position will assist a team of dedicated researchers in ...

Qc Manager, Analytical Jobs
By ProKidney Corp. At Winston-Salem, NC, United States
Able to clearly communicate problems and observations with management from other departments.
Manages QC analytical testing and personnel.
Manages day to day operations and weekly testing schedule.
Must have experience in writing technical documents and protocols.
5+ years experience in QC analysis in a GMP environment required
Leads the stability testing program and raw material testing program.
Analytical Lab Director Jobs
By CannabizTeam - Executive Search and Staffing At Baltimore, MD, United States
Complies with and supports continuous improvement of the ISO 17025 accredited laboratory Quality Management System.
Performs labeling and logging of samples using the Laboratory Information Management System (LIMS).
Processes, organizes and summarizes data and computerized results of analysis through the Laboratory Information Management System (LIMS)
If necessary provide remedial training or continuing education to improve skills.
Experience with ISO 17025, GMP, GLP, or similar certification process
PRIOR CANNABIS LAB TESTING EXPERIENCE IS REQUIRED ***
Analytical X-Ray Systems Specialist-Xrd
By RIGAKU AMERICAS HOLDING INC At , Boston, 02108
B.S. Degree or equivalent experience.
Minimum 3 years' experience diagnosing and repairing mechanical, electro-mechanical and/or electronic equipment.
Working knowledge of MS Office.
Excellent communication skills with the ability to communicate complex technical issues in an easy-to-understand manner.
Strong organizational and prioritizing skills.
Basic troubleshooting on-site using Digital Voltmeter (DVM).
Analytical Chemist Jobs
By Lantheus Medical Imaging, Inc. At , Billerica, 01862
Typical Minimum Skills and Experience and Education
Strong organizational, presentation and communication skills, both written and verbal
BS/BA usually requires 6 -10 years direct related industry experience
MS usually requires 4 - 8 years direct related industry experience
Ph. D. usually requires 2 - 4 years direct related industry experience
Experience working in a GxP environment a plus
Director, Analytical Development Jobs
By Icosavax At , Remote $175,000 - $215,000 a year
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Proven ability to function in multidisciplinary cross functional team environments using clear communication and matrix management skills.
Excellent self-management, organizational, and verbal/written communication skills.
PhD in chemistry, biochemistry, or closely related field, or equivalent experience applicable to the job responsibilities
Industry experience that includes transition of early-stage QC methods to late-stage programs including preparation of regulatory filings.
Experience with vaccine development and interactions with the Essential Regulatory Laboratories, desired
Analytical Chemist Jobs
By Johns Hopkins Applied Physics Laboratory (APL) At , Laurel, 20723
Have 2 or more years of direct analytical chemistry experience working with LC and GC instruments
Have 5 or more years of direct analytical chemistry experience in method development, instrument repair, and leading small teams
Are highly skilled at research and able to propose new projects and novel techniques
Have experience working in the field with analytical equipment or in austere environments
You'll go above and beyond our minimum requirements if you...
Your primary responsibility will be supporting method development and analysis using LC instruments
Qc Senior Scientist, Analytical
By Evotec At , Redmond
Experience with the operation, deployment, and administration of laboratory information management systems (LIMS).
Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and team milestones are achieved
Extensive knowledge of GdPs, GMPs and DS / DP multi-compendial assays (USP, EP, JP)
Excellent communication and collaboration skills
Experience with Waters HPLC, UPLC and Beckman PA800 CE systems
Experience with ELISA based impurity or potency methods
Development Scientist Ii, Analytical Development And Clinical Qc
By AstraZeneca At , New Haven, 06510
Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein)
Extensive experience in separations science (e.g., SEC, RP, IEX). Experience in Molecular biology (PCR, DNA extraction) and immunoassay (ELISA) techniques.
Experience of testing strategy for late-stage program in preparation for BLA filing
Excellent written skill for drafting all the GMP related documents.
Ensure communications occur with stakeholders and partners for all the analytical topics
Author analytical method transfer/validation related protocols and reports for late stage clinical and commercial programs.
Analytical X-Ray Systems Specialist-Xrd
By RIGAKU AMERICAS HOLDING INC At ,
B.S. Degree or equivalent experience.
Minimum 3 years' experience diagnosing and repairing mechanical, electro-mechanical and/or electronic equipment.
Working knowledge of MS Office.
Excellent communication skills with the ability to communicate complex technical issues in an easy-to-understand manner.
Strong organizational and prioritizing skills.
Basic troubleshooting on-site using Digital Voltmeter (DVM).
Analytical Chemist Jobs
By Vici Health Sciences At , Elkridge, 21075

Vici Health Sciences is an exciting and growing pharmaceutical R&D company located in Elkridge, Maryland. The work environment will be fun, flexible, and fast-paced. All Vici employees receive a ...

Associate Scientist/ Scientist- Analytical Chemistry
By NJ Bio, Inc. At Princeton, NJ, United States
Ph.D. in Analytical Chemistry, Organic Chemistry, Biochemistry or related areas with 0- 2 years industry experience
M.S. in Analytical Chemistry, Organic Chemistry, Biochemistry, or related areas with 2-4 years industry experience
More than 6 years of relevant experience with Bachelor’s degree
Must have practical experience with Mass Spectroscopy instruments such as QDa, QQQ, TOF & QTOF etc.
Experience in HPLC method development (SEC, RP, IEX, HIC etc.), , GC, for characterization of small molecules and/or large molecules characterization.
Ability to apply critical thinking and good problem-solving skills.
Quality Control Sr Associate Scientist, Analytical Chemistry
By Pfizer At North Carolina, United States
Experience with Laboratory Information Management System (LIMS)
Basic computer skills (data entry and attention to detail) in Microsoft
Excellent effective written and verbal communication and interpersonal skills
Experience in biotech or pharmaceutical industry
Experience leading continuous improvement projects.
Laboratory experience, including HPLC with Empower