We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
The Bioassay Development group is seeking a Scientist II with experience in qPCR, cell-based assays, ELISAs and plate-based testing. The successful candidate will primarily be responsible for the development and qualification of assays for the characterization and identity, purity, and strength assessment of recombinant protein drugs. The position will also manage a small team and manage technology specific client interactions, providing customer service and managing timelines for deliverables.
The successful candidate requires the following knowledge, skills and abilities:
- Direct experience using cell based assays, ELISAs, and qPCR for protein characterization and release testing
- Direct experience in interaction with clients to ensure deliverables fall within the applicable scope and budget. He or she will coordinate with other departments to ensure all aspects of each project are compatible, and will meet client needs
- Independent use and application of instrumentation, computer systems and software for data acquisition and analysis
- Basic math and software skills (MS Excel, Word, PowerPoint)
- Good interpersonal skills, the ability to work individually or as part of a team, and strong problem solving capabilities. Have strong oral and written communication skills.
- Experience managing direct reports or matrix management of scientists.
- Experience working in a regulated GMP environment is highly desirable
- In addition, the successful candidate must be comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines
- Optional additional experience which would be beneficial to the role:
- Client project management of one year or more
- Experience in Lean Six-Sigma principles and its implementation across project management and lab operations
- Originates development ideas
- 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
- Presents his or her own original ideas and development findings
Project Technical Leadership
- If the individual is assigned as a Technical Lead of a client project, these activities and responsibilities apply
- Maintain project timelines
- Responsible for communicating project milestones to project staff
- Responsible for writing project plan and experimental execution schedule to meet project timelines
- As appropriate, responsible for documentation for tech transfer to manufacturing or method qualification with QC
- Responsible for experimental design and planning experimental execution
- Responsible for ensuring lab equipment is setup for new program and implementing new technology needed for project execution
- Responsible for regular interaction with technical operations, manufacturing, QA or QC (as appropriate) to ensure successful process transfer
- Troubleshoot and resolve technical issues during development and transfer/scale-up to manufacturing or QC
- Ensure that project documentation follows R+D documentation practices
- Mentor junior staff on the project and planning junior staff activities for successful experimental execution
- Provide tier board updates as appropriate
- Serve as the primary liaison for the functional department to the client and internal customers
- Represent the functional department at internal meetings
- Responsible for providing written technical updates to the client and internal customers
- Creates plans to resolve project related issues
- Engage senior management in a timely manner when project issues or problems arise
- Provide monthly project reports to department head summarizing milestones, successes and issues
- Provide project updates as appropriate to CPL
- Takes responsibility for the consequences of his/her actions and openly admits mistakes and takes actions to correct situations/change behaviors
- Openly shares information, knowledge and expertise with co-workers
- Draws from disciplines beyond own areas of expertise when solving problems and making decisions
- Seeks opportunities for multi-disciplinary experiences and/or assignments outside comfort zone for personal development
- Researches how other teams have approached similar projects
- Maintains effective relationships with colleagues across functional units and gains their trust and respect.
- Provides guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem
Background Requirements – Education
- PhD and 1+ year experience,
- MS and 6+ years’ experience or,
- BS and 10+ years’ experience
- Client project management experience
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.