Responsible for utilizing analytical methodologies, systems, and processes to support drug substance and drug product development throughout all phases.
Responsibilities
Prepare, set up, and analyze drug substances and/or drug product samples using a variety of analytical techniques including chromatography (e.g., HPLC, UPLC, LCMS GC, GCMS, SFC), spectroscopy (e.g., UV-Vis, NMR), dissolution, and other relevant methodologies (e.g., KF, pH, ROI).
Support development and optimization of analytical methods, including assay, purity, dissolution, and/or impurity characterization approaches as appropriate.
Execute method qualification, validation, and transfer activities to support development and commercialization programs.
Conduct degradation, stability, and investigational studies to support the evaluation of product performance and risk.
Assess stability, dissolution, and/or impurity trends to support product and process development decisions.
Requirements
Bachelor’s degree in chemistry, biochemistry, or other related degree concentration
Masters or Engineers with 0-2 years of related experience
Apply advanced investigative techniques to train, review, and analyze products, processes and customer inquiries.
Responsibilities
Conduct standard and advanced analytical techniques including Gas Chromatography, bench titrations, Karl Fischer water titrations, pH, and specific gravity
Confirm material compliance with prescribed specifications
Maintain equipment logs
Follow established standard operating procedures and assist in developing additional methods
Review and update quality documents such as procedures & batch Instructions
Ensure the quality of the products through daily line audits in order to effectively meet or exceed standards set by MSI Express, the customer, and federal and state compliance.
Responsibilities
Approve/correct batches
Perform lab checks
Perform pre-ops and Preventive Control (PC) checks
Notification of up line
Perform all required analytical test per the given procedure
The Research Associate I will work as part of the Process Science team at ImmunityBio to contribute to our efforts to develop and implement processes and methods across ImmunityBio’s platforms, and the advancement of our pipeline by collaborating with internal and external partners.
Compensation
$67,000 (entry-level qualifications) to $73,700 (highly experienced) annually
Responsibilities
Assist in and provide support to engineers and scientists in Process Development of bench-scale upstream and downstream unit operations.
Assist in and provide support to engineers and scientists for various product platforms, process improvements and efficiencies in method development, optimization, and troubleshooting of analytical methods.
Participate in the collection and interpretation of data from bench-scale experiments and large-scale manufacturing data with guidance and oversight from supervisor or manager.
Set-up bench-scale experiments, including preparing buffers, solutions and assay reagents, with guidance and oversight from supervisor or manager.
Analyze and document experimental data in laboratory notebooks in a timely and accurate manner in accordance with the company guidelines.
Requirements
Bachelor’s degree in biological sciences or biomedical engineering
Nice to have: experience in a research lab setting
Nice to have: regulated pharmaceutical environment
Nice to have: training in handling and maintaining mammalian cell culture in a BSL-2 laboratory
Lead complex reagent and analytical method development for NGS-based clinical laboratory products, providing scientific and technical leadership within the Reagent Development team.
Compensation
$150,000—$170,000 USD
Responsibilities
Independently lead complex reagent-development projects from concept through implementation
Translate product, assay, manufacturing, quality, and business needs into practical reagent-development plans
Analyze and interpret complex datasets
Identify critical path activities, dependencies, resource needs, and emerging risks
Provide technical direction to scientists and associates
Requirements
PhD in Analytical Chemistry, Biochemistry, Chemistry, Molecular Biology, Chemical Engineering, or related field
M.S. with 7+ years of relevant industry experience
The compensation range for this role is $25.00 to $30.00 an hour, commensurate with experience, skills, and geographic location
Responsibilities
Serves as Team Lead and provides training and direction to other staff
Operates field monitoring equipment including but not limited to: PID/FID, pH, EC, DO, GEM, turbidity, water level, LEL meters, trimble (or other geolocating equipment)
Carefully documents monitoring and testing results on field forms and prepares field daily reports and data sheets
Collects samples using a variety of sampling methods
Conducts environmental collection, monitoring, sampling, testing and basic evaluation at various locations
Requirements
Bachelor's degree in Geology or Environmental Science
Nice to have: Familiarity with supervision of drilling
Nice to have: Familiarity with FDEP Petroleum Restoration Program
Nice to have: 3+ years experience in environmental collection, monitoring, sampling, testing and basic evaluation
The Quality Lab Associate I supports analytical testing, method validation/verification, and method transfer activities for parenteral products within the Global Quality Stability Laboratories team.
Compensation
The estimated base salary for this position is $68,000 - $93,500 annually.
Responsibilities
Conduct chemical, physical, and biological testing of stability samples to support commercial products and product development programs.
Perform testing of raw materials, in-process, and finished product samples using analytical instrumentation and laboratory systems.
Execute routine, non-routine, and protocol-driven testing activities to support project timelines and business objectives.
Generate, review, and document analytical data while maintaining compliance with data integrity standards and laboratory procedures.
Ensure compliance with SOPs, FDA regulations, cGMP, and other applicable quality requirements.
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