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 searching for a Senior Administrative Assistant to join our dynamic team in Manufacturing. The candidate will perform in diverse and advanced secretarial duties and administrative support for the manufacturing site (Commercial Process, Manufacturing Technology & Support, Manufacturing, Quality Control) and the Senior Director of Manufacturing. The ideal candidate will have experience with MasterControl.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
Main areas of responsibility include:
- Prepare the manufacturing Monthly Reports
- Take monthly staff meeting minutes for manufacturing (may require evening hours)
- Schedule technician team brief meetings and other training events
- Special event planning for manufacturing, including holiday meal support, and assist in event planning for entire site for some events (This can require some weekend and night support).
- Assist with SOP, TM and WI revisions in GMP documentation system
- Assist with the Pink Card Digital Database
- Manage the area inspection system
- Support GMP logbook review, correction, and completion and issuance process. This requires gowning into the GMP area weekly.
Other duties include:
- Gather, assemble and analyze information and data from a wide variety of sources
- Order catering for large groups, client meetings, etc.
- Coordinate and schedule executive/corporate/visitor tours for the Manufacturing facility
- Assist in scheduling interviews
- Obtain, prepare and retain sensitive information with the highest confidentiality. Comply with standard record keeping and maintain highly confidential files
- Prepare and arrange meetings, calls and events – set up, manage and monitor multi-party conference calls, meetings, meeting rooms, etc.
- Manage mail box and locker assignments
- Complete the PIP Coverage Monthly Report
- May coordinate large events such as All Employee Meetings, off-site events, etc.
- Identify and resolve problems in a timely manner as necessary
- Receive and interact with incoming visitors
- Liaise with corporate and internal staff at all levels; Partner harmoniously with many levels in the organization
- Reviews and answers mail and inquiries on own initiative and determines within established guidelines if executive action is required
- Refers routine matters to appropriate parties for action and follows up to ensure proper disposition
- Communicates with executive, administrative and line management to gather and convey information pertaining to superior’s office and responsibilities
- Answer telephone calls, tactfully handles inquiries and/or refers to appropriate party
- Coordinate and make notifications and arrangements for travel reservations and appointments via Concur
- Type material in final form from rough or involved drafts which may utilize frequent use of technical terminology and statistical data
- Operate a variety of general office equipment such as copier, calculator, printer and personal computer
- Frequent contact with customers, corporate executives, both internal and external
- Assist in completing expense reports through Concur
This position reports directly to the Senior Director of Manufacturing.
Education and Experience
- Minimum of an AA degree in science or related field, or three years of related experience
- Knowledge of GMPs with the ability to interpret and apply to non-routine situations
- Significant experience and capability supporting a senior or executive role
- Proficient computer skills and in-depth knowledge of relevant software such as MS Office
- Knowledge of standard office administrative practices and procedures
- Experience with MasterControl is preferred
- High organizational and planning skills
- Good written and verbal communication skills
- Information gathering and monitoring skills
- Problem analysis and problem solving skills
- Ability to make decisions at the appropriate level
- Adaptable team member
- Great attention to detail and accuracy
- Manage shifting priorities with flexibility and accuracy
- Expected to strictly maintain confidentiality and exhibit discretion and professionalism in all activities
- Can work independently with little or no supervision
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.