Scientist Genomic Medicine Bioanalytics Qc Jobs

Knowledge of GMP compliance requirements for Quality Control Laboratories

Knowledge and practical application of relevant techniques – classic microbiology techniques as well as rapid microbial techniques, desired.

Experience with LWLIMS, MODA, EAMS, QTS and PDOCs is a plus.

Normal lifting, sitting, standing and walking requirements to facilitate testing in a laboratory environment.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Perform bioburden, endotoxin, and TOC assays

B.S. degree in biochemistry, molecular biology, chemistry, or other related fields with 5+ years of relevant working experience.

M.S. degree in biochemistry, molecular biology, chemistry, or other related fields with 3+ years of relevant working experience.

Strong laboratory skills with an understanding of molecular biology techniques, optical spectroscopy methods and instrumentation including absorbance and fluorescence.

Conduct analytical and functional testing of raw materials, intermediates, and finished goods.

Work in a Biosafety Level II (BSL2) laboratory, using blood, tissue, and cultured cell lines.

Researching issues which arise during routine analysis.

1+ years of relevant experience within a laboratory setting.

Equivalent experience working in a cGMP environment preferred

Knowledge of GMP regulations in cGMP manufacturing environment preferred.

Excellent problem solving and critical thinking skills

Excellent organization and planning skills.

Medical, Dental, & Vision benefits-effective Day 1

Comprehensive and solid experience in general molecular biology and cell culture techniques are required for this role.

Extensive experience in bioanalytical methods and assay development across multiple platforms (e.g., ELISA, MSD, Luminex) is highly desired.

In-depth experience in multi-parameter flow cytometry (e.g., surface staining, nuclear antigens, viability, proliferation, cytokines, etc.), including panel development and troubleshooting.

Experience in gene editing and genome engineering technologies.

Experience in stem cells and/or tissue biology.

Experience with performance of experiments in mouse models is a plus.

Experience with the transfer/qualification/Validation of GMP assays.

Experience in writing SOPs and Test Methods as well as method qualification/validation, method transfer and verification documentation.

Broad experience with biochemistry and biological assay support, as well as generating/reviewing the documentation that supports such work

Possesses the knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks

Specific vision requirements include reading written documents and frequent use of a computer monitor

Medical, Dental, Vision, and 401K are all offered from day one of employment

Strong interest and experience in machine learning and deep learning

Strong communication skills and ability to present the research findings to the team

Developing machine learning models to investigate functional implications of in-vitro and in-vivo perturbations

Data visualization and interpretation of biological findings

Presenting research findings to the team in weekly and monthly meetings

Currently pursuing B.S., M.S., or Ph.D. degree in computer science, computational biology, bioinformatics, biostatistics, statistics, or related quantitative fields.

Knowledge of clinical trial research; ideally, 1-2 years experience working in clinical trials for a pharmaceutical company.

Ensure vendors are properly managed and supported to perform cultures and other related TB specific testing; including

Excellent understanding and knowledge of microbiology aspects related to tuberculosis identification and treatment.

Laboratory experience with automated microbiology identification and susceptibility test systems, preferably hands-on Bactec MGIT experience.

Strong knowledge of quality control and quality assurance systems.

International work experience in resource-limited countries desired.

Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.

Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs.

Prepare and present continuous improvement projects to management.

Advanced hands-on experience with various analytical techniques primarily flow cytometry and scientific knowledge in the characterization and transfer of analytical methods.

Advanced ability to communicate effectively with peers, department management and cross-functional peers.

Ability to work with management locally and globally.

Experience will have been gained in similar types of study management (either internal or external).

Knowledge of the client requirements and plan accordingly to meet Client deadlines.

Coordinate or facilitate the scheduling or management of lab work, where necessary.

Identify and communicate adverse events to management and seek and find solutions to problems.

Knowledge of capabilities and expertise of the Labcorp organisation and companies that may provide support services.

Attend client conference calls and meetings for specific technical requirements arising during projects.

Assist with writing computer codes to establish new computational pipelines using R, Python, and C++.

Create new scripts as directed to carry out specific data manipulation or adapt published software to project needs and computational infrastructure.

Provide assistance and input in developing and implementing workflow for data analysis in collaboration with research scientists. Assist with hypothesis testing.

Under direct supervision, build and deploy data analysis support systems for large data sets.

Interact closely with systems administrator to provide assistance for maintaining and running software packages for next generation sequencing data analyses.

With supervision and assistance from senior bioinformatics personnel and PI, conduct data QC, sequence alignment, sequence analyses, annotation, and interpretation.

Exercise and build basic team effectiveness skills, such as commitment, feedback and consensus management, within the work group.

Act safely and follow Environment, Health and Safety requirements for site and QC laboratories.

Lab Experience in basic analytical methods: HPLC, UV, pH

Knowledge of Advanced analytical methods: Peptide map and Oligosaccharide, ELISA, iCE, CE

Strong oral and written communication skills

Knowledge and understanding of cGMP and industry standards

Sufficient depth of knowledge within their scientific discipline and previous area of experience

Awareness to know their own limitations and seek senior scientist or management guidance when appropriate

Willingness to use personal skills and knowledge to achieve individual and company goals and objectives

Understands the importance of feedback and receives feedback well from management and other colleagues

Makes good decisions based on knowledge of quality systems/technical experience and work is accurate with little to no errors

sufficient depth of knowledge within their scientific discipline and previous area of experience

Comprehensive and solid experience in general molecular biology and cell culture techniques are required for this role.

Extensive experience in bioanalytical methods and assay development across multiple platforms (e.g., ELISA, MSD, Luminex) is highly desired.

In-depth experience in multi-parameter flow cytometry (e.g., surface staining, nuclear antigens, viability, proliferation, cytokines, etc.), including panel development and troubleshooting.

Experience in gene editing and genome engineering technologies.

Experience in stem cells and/or tissue biology.

Experience with performance of experiments in mouse models is a plus.

Knowledge of testing and associated equipment protocols and requirements and analytical/microbiological testing instrumentation.

Good verbal and written communication skills.

Direct experience of three (3) years within cell culture, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is helpful.

Knowledge of cGMP practices, aseptic techniques, and microbiological concepts

Knowledge of industry standards such as ISO, ICH, FDA and USP preferred

Investigation and experience with Root Cause analysis, preferred

Knowledge in T cell biology and hands-on experience with T cells

Collaborate cross-functionally to characterize and optimize leading RNA writer candidates, advance our knowledge in RNA writer biology

Apply knowledge of molecular biology of the cell to address complex biological questions

Manage and train junior research associates

Experience in culturing immortalized and primary mammalian cell lines and transfection techniques

Strong written and oral communication skills

Authors final reports for assay qualifications

Interacts with clients for assay qualification activities

1-2 years experience in science or science related field

Experience performing environmental monitoring, critical utility sampling, and assays

Strong interpersonal and communications skills; written and oral

Ability to manage timelines and meet internal/external deadlines

Experience with a quality management system (QMS)

BS in Biochemistry, Chemistry or related field and 5 – 8 years of experience

5+ years of relevant experience in a cGMP QC laboratory or similar environment

Experience with Waters HPLC, UPLC and Beckman PA800 CE systems

Knowledge of GDPs, GMPs and DS / DP compendial assays (USP, EP, JP)

Experience with ELISA based impurity or potency methods

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Knowledge of analytical techniques such as HPLC, GC, FTIR, Osmolarity and pH, hands-on experience preferred.

Ability to recognize and communicate simple and complex problems with relevant team member, department management and cross-functional peers.

An equivalent combination of education and experience may substitute.

Assist management with investigations and deviations.

Communicate effectively with management regarding task completion, roadblocks, and needs.

Ensures compliance with cGMP and safety requirements within the QC analytical laboratory

Conducts training on applicable SOPs, regulatory requirements and quality initiatives

Knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology

Broad experience with biochemistry , as well as generating/reviewing the documentation that supports such work

Possesses the knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks

Medical, Dental, Vision, and 401K are all offered from day one of employment