Scientist Ii Analytical Jobs in San Diego, 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

Excellent verbal, presentation and written communication skills are essential and capacity to effectively work in a team environment

Experience working with internal and external teams in a collaborative environment to deliver on goals and deadlines

Outstanding problem-solving and data analysis skill and ability to independently record scientific progress and maintain detailed laboratory notebook

Previous industry experience in Biotech or Pharmaceuticals

Experience reviewing the proper operation and maintenance of current laboratory equipment and analytical instruments

M.S. with minimum of 2-4 years or B.S./B.A. with 3-5 years Biotech or Pharmaceuticals industry experience preferred

Minimum Qualifications – Education And Experience

Preferred Qualifications – Education And Experience

Other projects or responsibilities as may be required.

M.S. with generally more than 8 yrs of relevant working experiences.

Ph.D. with generally 2-4 years of post-doctoral training or relevant working experiences

Experience in process development and optimization for stem cells and/or hybridoma cell culture

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

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

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.

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.

PhD in chemistry, chemical engineering, or a related field or MS +3 years of experience

Demonstrated experience with the design and synthesis of complex novel targets

Relevant laboratory experience in life science applications.

Experience executing molecular biology assays.

Experience in surface chemistry, polymer chemistry, bioconjugation and surface functionalization.

Experience with imaging of biological samples

Excellent oral (including public speaking) and written communication skills

Experience building and/or working in collaborative, diverse and inclusive team environments

Strong interpersonal skills, demonstrated through mentorship, listening and good communication

The following qualifications are required:

Develop and/or refine existing open-source aquatic algorithms for SBG, and lead their validation

Lead SBG DEIA collaborations and activities with minority and underrepresented groups

iota offers a very competitive benefits package that includes the following:

Maintains in-depth scientific knowledge in relevant therapeutic areas

Bachelor's degree with 2+ years research experience in biology, oncology, or immunology

Experience with molecular and/or cell-based assays or histopathology

Experience in independently optimizing experimental methods and assays

Experience working in interdisciplinary environments and building relationships with key external partners

* 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.

Wellness, caregiver and ergonomics, mental health and education benefits

1+ years of hands-on experience designing and analyzing CRISPR gene editing or epigenetic editing experiments in mammalian cells

1+ years hands-on experience in three of the following areas:

1+ years experience developing novel CRISPR tools for gene and epigenetic editing

1+ years experience developing novel assays in human cells for high throughput tool evaluation

1+ years experience working with disease-relevant human cell lines and primary cells

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.

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.

Prior experience binding adsorbents into structured forms/materials, such as integration of adsorbents into polymers, membranes, films, fibers, pellets, or extrudates

Minimum of 3 years of research experience post the PhD degree

Experience in synthesis and analysis of MOF and COF materials

Analyze and optimize the heat-transfer properties of different binder systems to achieve optimum MOF/COF system scale performance

Evaluate MOF/COF coatings and structured material stability to various process conditions (temperatures, flow rates, mechanical vibrations)

Quantify adsorption capacity and rates of MOF/COF coatings and structured materials as compared to pristine MOF/COF materials

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.

Track record of challenging oneself to enhance scientific skills and knowledge

Experience working in a cross collaborative team including bioinformaticians and project managers

Ph.D. in biology or a related discipline with relevant research experience

Experience with chromosomal rearrangements and translocation analysis

Excellent organizational skills and both oral and written communication skills

Ability to think strategically, manage time and workflow, and work independently as well as in a results-oriented research team

Broad knowledge and application of business concepts, procedures and practices. Will perform this job in a quality system environment.

Has broad knowledge of various technical alternatives and their potential impact on the business

Career development with an international company where you can grow the career you dream of .

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

An excellent retirement savings plan with high employer contribution

Develop the scientific podium and publication strategy in close collaboration with cross-functional teams, and lead the execution of the publication strategy

Manage CRO activities and collaborate with other functional teams to support and advance all Pheast programs

PhD. in Molecular Biology, Cancer biology, Immunology or related fields with minimum 2 years of post-doc or industry experience

Experience with various molecular biology techniques (e.g. tissue culture, gene overexpression/knock-out) is required

Experience in high-throughput screening methods and/or conducting omics-data analysis (e.g. single cell RNAseq, NGS) is highly preferred

Experience with in vivo studies is highly preferred

Experience in flow cytometry and/or working with immune cell is highly preferred

Lead AbbVie global drug product initiatives and manage direct reports.

Prior experience demonstrating independent critical thinking for technical problem-solving and driving fundamental science through innovative science is highly desirable.

Excellent communication and written skills are required.

Generate high-quality data based on sound scientific principles and prepare formulation data summaries, technical reports, scientific presentations, and regulatory documents.

Raise the external influence of Abbvie in the scientific community through external presentations, patent applications, and publications.

South San Francisco-based position with 10-20% business travel.