Senior Scientist needed!

Overview:

The Senior Scientist will lead and support analytical development, assay qualification, and GXP early-stage assay development projects, with focus on safety assays (sterility, endotoxin, mycoplasma, adventitious agents) for protein and cell therapy drug products, drug substances, and process intermediates. This role requires relevant experience in analytical method development under the GMP and ICH guidelines. The candidate should be highly proficient and have subject matter expertise in microbiology, protein chemistry, and analytical methodology. The scientist will be responsible for timely planning, documentation, execution, and reporting to facilitate analytical and process development goals. Experience is required in developing pre-clinical packages for IND and in developing BLA/MAA submissions and post-marketing supplements.

Essential Functions and Responsibilities:

• Lead and provide scientific oversight of analytical/microbiological strategy and studies for the evaluation of safety attributes of protein and cell therapy drug products, drug substances, and process intermediates, including assay format selection based on risk-assessment and fit-for-purpose.
• Lead and execute method development, qualification, validation or verification, troubleshooting and sample analysis by QbD approach and harmonized to USP monographs. Ensure assays are developed and executed per applicable Guidance and Regulations. Contribute to assay protocol and qualification/validation report preparation. Address quality assurance (QA) findings and observations.
• Subject matter expertise in developing and performing analytical methods and data analysis of release assays for endotoxin, sterility, mycoplasma, and adventitious agents, including experience with development and implementation of rapid techniques.
• Perform development studies and suitability of endotoxin assays encompassing expertise across a full range of techniques including LAL gel-clot, kinetic and end-point chromogenic, and turbidimetric methods, and in vitro Monocyte Activation Test, including for Control Standard Endotoxin, Reference Standard Endotoxin and Low Endotoxin Recovery.
• Author protocols and associated reports per Good Documentation Practices (GDP). Compile data packages, reports and author/review sections for regulatory filings.
• Lead, train and mentor small technically focused group of associates and junior scientists. Provide technical leadership and scheduling for the team to ensure deliverables, coordination of external testing required, and data collection.
• Serve as department subject matter expert supporting all aspects of external planning and execution of outsourced activities by CROs. Provide project management oversight of, and demonstrate ability to troubleshoot, external contracts for analytical method and critical reagent testing.
• Provide project updates on execution to timelines and resource allocation requests. Demonstrate professional-level presentation and communication skills in providing summaries of complex analysis of data sets to Senior and Executive level staff.
• Maintain a high level of professional expertise through regular consulting of scientific literature and attendance of training and/or scientific seminars. Investigate and develop new methods and technologies necessary for project advancement. Help identify patentable inventions. Contribute to scientific presentations and publications.
• Ensure training is up to date on new processes and analytical methods. Ensure compliance and maintenance of lab safety, environment, and quality. Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.

Travel – <20% of the time

Required Education, Skills, and Knowledge:

• Ph.D. with 8+ years of industry experience or master’s degree with 10+ years of industry in Biology, Microbiology, Virology and/or Molecular Biology fields.
• GMP or Quality experience with proficiency with regulatory compliance and FDA guidelines for Title 21 Code of Federal Regulations part 211 current Good Manufacturing Practices (cGMP) and Good Clinical (Research) Practices (GCP), ICH standards for analytical test methods as required, United States Pharmacopeia (USP).
• Prior experience developing and supporting protein drug substance and drug product development.
• Prior experience with development and validation of assays utilizing GC-MS, qPCR, in-vitro cellular assays, and fluorescent endpoint and chromogenic assays.
• Knowledge of medical terminology and intellectual capacity to use judgment and critical thinking skills to ensure that the data are accurate, logical, and consistent with internal and regulatory reporting requirements are required.
• Must be capable of working in a fast-paced, collaborative environment and managing multiple concurrent projects with high independence.
• Strong interpersonal, written, and oral communication skills are required.
• Must be organized, able to multi-task, and be a team player.

Preferred Education, Skills, and Knowledge:

• Experience with development of cell therapy products is preferred.
• Experience with supporting clinical and commercial drug product manufacturing is preferred.