Senior Scientist

5 days ago

Tampa, United States Planet Pharma Full time

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 –

  • Senior Scientist

    5 days ago

    Tampa, United States Planet Pharma Full time

    Senior Scientist needed (Analytical Development, Molecular)!Location: Tampa, FL Salary: market rate Essential Functions and ResponsibilitiesLead and provide scientific oversight of analytical strategy and studies for the evaluation of safety attributes of cell therapy and protein drug products, drug substances, and process intermediates, including assay...

  • Environmental Scientist Senior

    1 month ago

    Tampa, Florida, United States Tetra Tech Full time

    Are you a seasoned environmental professional looking for a new challenge? We have an exciting opportunity for a Senior Environmental Scientist to join our team at Tetra Tech.Job SummaryWe are seeking a highly experienced and skilled Senior Environmental Scientist to lead and conduct various environmental projects, including environmental site assessments,...

  • Senior Scientist

    5 days ago

    Tampa, United States Planet Pharma Full time

    Senior Scientist (Analytical Development, Microbiology) Needed! Salary: market rate Location: Tampa, FLEssential Functions and ResponsibilitiesLead 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,...

  • Senior Scientist, Analytical Development, Microbiology

    5 days ago

    Tampa, United States Planet Pharma Full time

    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...

  • Planet Pharma | Senior Scientist | tampa, fl

    5 days ago

    tampa, United States Planet Pharma Full time

    Senior Scientist needed (Analytical Development, Molecular)!Location: Tampa, FL Salary: market rate Essential Functions and ResponsibilitiesLead and provide scientific oversight of analytical strategy and studies for the evaluation of safety attributes of cell therapy and protein drug products, drug substances, and process intermediates, including assay...

  • Planet Pharma | Senior Scientist | tampa, fl

    4 days ago

    tampa, United States Planet Pharma Full time

    Senior Scientist needed (Analytical Development, Molecular)!Location: Tampa, FL Salary: market rate Essential Functions and ResponsibilitiesLead and provide scientific oversight of analytical strategy and studies for the evaluation of safety attributes of cell therapy and protein drug products, drug substances, and process intermediates, including assay...

  • Senior Scientist, Process Development Specialist

    1 month ago

    Tampa, Florida, United States Iovance Biotherapeutics Inc Full time

    Job SummaryThe Senior Scientist, Process Development Specialist will be responsible for supporting the development and technology transfer of a genetically engineered TIL product. This role will involve leading the development of certain stages of the TIL manufacturing process, designing and executing development and characterization studies, and supporting...

  • Planet Pharma | Senior Scientist, Analytical Development, Microbiology | tampa, fl

    5 days ago

    tampa, United States Planet Pharma Full time

    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...

  • Environmental Scientist Senior

    6 months ago

    Tampa, United States Tetra Tech Full time

    The Environmental Scientist V position will be responsible for leading and conducting various projects, including but not limited to environmental site assessments including the sampling of environmental media, wetland delineations, Threatened and Endangered (T&E) surveys, environmental permitting, due diligence investigations, and preparation of technical...

  • Senior Big Data Engineer

    4 weeks ago

    Tampa, Florida, United States Okaya Full time

    Job Title: Senior Big Data EngineerOverview: We are seeking a highly skilled Senior Big Data Engineer to join our team at Okaya. As a key member of our engineering team, you will be responsible for designing, developing, and maintaining large-scale big data systems using Hadoop, Spark, and Scala.Responsibilities: Design and develop big data architectures...

  • Senior Environmental Engineer

    1 month ago

    Tampa, Florida, United States Jobot Full time

    Job SummaryWe are seeking a highly skilled Senior Professional Engineer to join our team in Tampa, Florida. The ideal candidate will have 7+ years of progressive environmental engineering experience, including experience with hazardous waste, air/wastewater permitting, environmental due diligence, and site assessment.Key ResponsibilitiesMentor junior...

  • Senior Traffic Engineer

    4 weeks ago

    Tampa, Florida, United States Faller, Davis & Associates, Inc. Full time

    Job Summary:FDA's Traffic design team performs major traffic signal, lighting, signing and pavement marking, and ITS plans as a prime consultant, subconsultant, and in-house support. We are seeking a Project Manager/Senior Traffic Engineer for a full-time position in the Tampa office.Key Responsibilities:Develop signing and pavement marking, traffic signal,...

  • Senior AI/ML Architect in Finance

    4 weeks ago

    Tampa, Florida, United States Hispanic Technology Executive Council Full time

    OverviewThe Hispanic Technology Executive Council is seeking a highly skilled Senior AI/ML Architect to join our team in Tampa, Florida. This is a full-time position that offers a competitive salary range of $141,440.00 - $212,160.00 per year, in addition to a comprehensive benefits package.Job DescriptionThe Senior AI/ML Architect will be responsible for...

  • Senior Analyst

    4 weeks ago

    Tampa, Florida, United States Diverse Lynx Full time

    Build a career with Diverse Lynx LLC, a company that promotes diversity and equality in the workplace. Our data scientist role involves analyzing complex data to identify trends and insights that drive business decisions.Key Responsibilities:Collect and process large datasets to extract meaningful informationAnalyze data to identify patterns and...

  • Senior AI/Python Developer

    4 weeks ago

    Tampa, Florida, United States C4 Technical Services Full time

    Job Summary:As a Senior AI/Python Developer at C4 Technical Services, you will be responsible for developing, programming, and coding of Information Technology solutions using Python to enable Florida Blue Customer Experience applications. Your primary focus will be on modernizing components using AI technologies on a Python-based platform.Key...

  • Senior Water Resources Consultant

    1 month ago

    Tampa, Florida, United States Verdantas Full time

    Job DescriptionWelcome to Verdantas, where innovation meets sustainability, and your career finds purpose. As a pioneer in delivering comprehensive environmental consulting, sustainable engineering, cutting-edge modeling, and digital technology services, we play a pivotal role in shaping sustainable project outcomes across diverse sectors.Our dynamic team,...

  • Senior Prompt Engineer

    4 weeks ago

    Tampa, Florida, United States Doran Jones Inc Full time

    Job Title: Senior Prompt Engineer - AI Model Optimization SpecialistAbout the Role:We are seeking a skilled Prompt Engineer to join our team at Doran Jones Inc. As a Prompt Engineer, you will be responsible for crafting and optimizing prompts to improve AI model outputs for various use cases, including text generation, question answering, and...

  • Senior Manager

    3 months ago

    TAMPA, United States USAA Full time

    Why USAA?Let’s do something that really matters.At USAA, we have an important mission: facilitating the financial security of millions of U.S. military members and their families. Not all our employees served in our nation’s military, but we all share in the mission to give back to those who did. We’re working as one to build a great experience and...

  • Senior Intelligence Operations Specialist

    4 weeks ago

    Tampa, Florida, United States Celestar Full time

    Celestar Corporation, a Veteran Owned Company, is seeking a highly skilled Intelligence Management Specialist to support the United States Central Command (USCENTCOM) Directorate of Intelligence (J2).You will be responsible for conducting research, preparing intelligence assessments, and providing administrative support to analysts, engineers, and...

  • Senior Python Developer

    1 month ago

    Tampa, Florida, United States Doran Jones Inc Full time

    Job DescriptionWe are seeking a talented Python developer to join our team at Doran Jones Inc. as a Senior Python Developer.About the Role:We are looking for a skilled Python engineer to work on high-impact projects that will directly enhance the company's operational risk management capabilities.Responsibilities:Design, implement, and maintain...