Analytical Research And Development Scientist Jobs in California

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

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.

* 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.

Proven experience with assays, such as PCR, ELISA, and /or mammalian cell culture.

Positive, professional self-starter with a passion for science, innovative technical and analytical skills required to perform at the highest level

Excellent clear and concise writing skills for technical reports and documents along with strong verbal communication skills

Experience in analytical method development and assay transfer

Be BOLD (Find a Way)

Care Deeply – for our patients, each other and our work

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.

4.Knowledge of protein purification methods and chromatography techniques (e.g., Ni-NTA sepharose, Protein A/G resin, spin columns).

6.Experience with data analysis and scientific software tools, such as Snapgene, Prism.

7.Excellent organizational, communication, and problem-solving skills.

Research Associate/Scientist Molecular biology and protein purification

Multiverse Pharma, San Diego, CA

Send your letter of interest with credentials to:

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

A Manager with broad experience, passionate about the science, with an extensive research and development portfolio

Perform routine and novel testing to support biological therapeutic products from early-stage development through late-stage/commercialization and their lifecycle management.

A team with broad experience and passion for science

Excellent verbal and written communications skills

Experience troubleshooting and developing analytical methods.

Experience in analytical method troubleshooting, optimization, and validation.

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

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.

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.