Senior Scientist, Analytical Development

FUJIFILM Diosynth Biotechnologies•College Station, TX

63d•Onsite

About The Position

The Senior Scientist designs, executes and interprets complex laboratory experiments and development activities with broad priorities set by supervisor to achieve project goals. The individual demonstrates a strong application of scientific knowledge to the design, conduct, and implementation of studies and projects and possesses a solid theoretical understanding of Analytical and or Virological assays. The individual will lead multiple client projects and support the transfer, develop and qualification of a variety of assays, as well as provide technical support for associated regulatory filings. The individual is expected to provide strong scientific and technical contributions within the Process Development Group and will work closely with other Departments to develop strong working relationships. The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

Ability to provide mentorship to junior staff on the project and planning junior staff activities for successful experimental execution
Able to apply computer systems, instrumentation, and data analysis knowledge to complex situations
Proficient with analytical instrumentation such as analytical chromatography/ELISA/qPCR.
Proficient in assay development.
Ability to work independently as part of a project team.
Demonstrated ability to multi-task across different project activities
Proficient in performing multiple assays such as ELISA, SDS-PAGE, Western blotting, HPLC, CE, cell-based assays, immunoassays, and/or molecular assays such as q-PCR or ddPCR.
Ability to work on multiple projects.
Experience working in a GMP environment is preferred.
Good understanding of qualification of analytical methods.
Good understanding of analytical process characterization.
Advanced knowledge of statistics for analytical chemistry.
Ability to formally present problems, updates, and/or results to internal and external clients.
Significant knowledge of bioanalytical techniques demonstrated through industry or academic performance.
Ability to clearly communicate in writing and verbally to senior management and clients.
Ability to write and perform detailed complex analytical procedures.
Ability to train junior staff and peers in technical aspects of the job.
Writes and reviews departmental technical reports (memos, development reports etc.) containing cross-discipline information
Role model for company core values of trust, delighting our customers, and Gemba.
PhD in Biochemistry, Chemistry, Biology, Life Sciences, or related field with 1+ year of relevant experience; OR,
Master's Degree in Biochemistry, Chemistry, Biology, Life Sciences, or related field with 6+ years of relevant experience; OR,
Bachelor's Degree in Biochemistry, Chemistry, Biology, Life Sciences, or related field, with 8+ years of relevant experience.
Must have some previous experience of leading projects and managing project teams.

Nice To Haves

Experience or knowledge of cGMP, QA, and QC for pharmaceutical products.
Strong hands-on skill in aseptic technique, cell culture, and virology.

Responsibilities

Provides leadership for manufacturing operations of the drug product team.
Lead the development or adaptation and implementation of analytical methods for customer programs.
Develop, optimize, and transfer methods on multiple client projects and acts as the lead on multiple client projects or one large client project and a small project.
Organize and oversee project timelines to meet milestones on multiple projects.
Independently applies scientific knowledge to achieve project goals.
Individual draws conclusions from scientific findings and applies these findings to the project.
Suggests new innovative ideas and technologies.
Work with internal department groups to track timelines and provide timely updates to the client groups.
May assist in the review of client proposals.
Lead the development, transfer and implementation of analytical assays e.g., ddPCR, qPCR, HPLC, ELISA, & bioassays.
Lead interactions with external clients to understand their needs and effectively communicate these needs to internal departments. Ability to work with team members and client to troubleshoot and solve complex problems to keep the client satisfied and happy with end results.
Provide tier board updates as appropriate.
Serve as the primary liaison for the functional department to the client and internal customers.
Designs, executes, and interprets complex laboratory experiments with broad priorities set by supervisor.
Application of statistical concepts and performs higher level analyses involving analytical or process experimental design.
Applies advanced scientific knowledge associated with larger and more complex experiments and projects.
Interprets and judges the quality of experimental outcomes and data to effectively draw conclusions and make recommendations regarding project execution.
Provide technical leadership for higher level analyses involving analytical experimental design.
Initiate new experimental approaches and related work processes and procedures that align with company and regulatory requirements.
Partner across company functions and collaborates effectively with respect to identifying and addressing problems and opportunities that affect or require input from multiple units within the company.
May approve reports for external distribution when acting as project technical lead.
Makes presentations within department and may present outside of department.
Present papers or posters at scientific meetings.
Maintain analytical instrumentation as needed and interface with external vendors for instrument installation and operation qualifications.
Perform as the SME and lead technical training to peers as needed.
Stay abreast of new technologies in the field.
Expand expertise to other types of assays.
All other duties as may be assigned.