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.
We are seeking a highly motivated individual for a Senior QA Manager (LIMS) position. The successful candidate will be responsible for developing the strategic plans for the implementation of FDB’s global LIMS (laboratory information management system). This individual will be responsible for harmonizing process across all FBD sites, present and future. In addition will be responsible to drive QC to a paperless environment. Will direct a team of LIMS experts to interpret global and site-specific needs into user and system design and configuration requirements and into the implementation plan. The individual will be the primary LIMS subject matter expert (SME) and will maintain and continuously improve the global LIMS system.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Provide cross-functional leadership as the recognized LIMS authority to:
- Develop the strategic implementation plan, hire LIMS staff, and oversee the LIMS project budget.
- Ensure that data integrity principles are fundamental to the LIMS implementation.
- Direct LIMS staff who will:
- Determine user requirements and best practices to improve laboratory functions, cycle times and efficiency.
- Identify and analyze improvement opportunities for the LIMS implementation process.
- Write, execute and review LIMS validation protocols, SOPs, test scripts and training materials.
- Configure, customize, maintain and upgrade the LIMS system.
- Build Master Data templates for LIMS.
- Provide end-user support to assist and train new users with data entry and reporting.
- Evaluate, schedule and balance workload and responsibilities:
- Assist less experienced staff
- Identify system improvements and implement those improvements
- Embed quality and regulatory compliance into the LIMS design
- Prepare and deliver presentations to internal and external customers
- Other duties as assigned
Minimum Education & Experience Requirements:
- Minimum of BS degree in a relevant field.
- Minimum of 10 years of GMP and LIMS experience in pharmaceutical industry.
- Proven experience in full life cycle implementation of multi-site LIMS, preferable both on LabWare v6 and v7.
- Proven experience in connecting analyzers to the LIMS and ability to provide a roadmap from Development to QC.
- Extensive knowledge of GMPs, computer system software development and validation, with the ability to apply to non-routine situations.
- Deep understanding and command of LIMS requirements.
Also requires a demonstrated track record in the following key areas:
- Ability to interpret regulations and apply to non-routine situations
- Strong orientation for quality, compliance, business ethics and customer service
- High level of integrity, personal discipline and personal responsibility.
- Exhibit strong collaboration, flexibility and able to manage multiple changing priorities
- A strategic thinker, able to motivate, lead and develop subordinates and communicate effectively with the leadership
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.