The Lead Associate 1, Quality Control (QC) Microbiology oversees and guides the critical operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting microbiological assays, as well as effectively training junior analysts in these areas. The role is pivotal in guaranteeing “right the first time” execution to support timely batch disposition of manufacturing goods. Additionally, this role ensures technical issues are promptly escalated to laboratory management and upholds high standards of accuracy and efficiency within the laboratory operations.

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.

Principal Accountabilities:

• Performs complex microbiological testing (e.g., Bioburden, Endotoxin, Culture Purity, and Microbial Identifications) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches
• Reviews technical data, authors routine and periodic laboratory reports (e.g., Environmental Monitoring (EM) trend reports) and contributes to technical documentation and assessments
• Supports client audits and regulatory inspections as an assay or method Subject Matter Expert (SME), as needed
• Ensures laboratory maintains inspection readiness, data integrity, and Current Good Manufacturing Practice (CGMP) compliance
• Partners with management for technical services, such as initiating events (e.g., deviations and non-conformances) within quality systems
• Leads laboratory deviations and investigations
• Identifies and solves problems while informing and consulting with management
• Participates in project developments from concept through execution, ensuring alignment with organizational goals
• Partners with laboratory management to schedule daily, weekly, and non-routine testing and tasks
• Provides technical guidance and mentorship to junior associates
• Participates in laboratory equipment qualification and validation activities
• Troubleshoots laboratory equipment, assay and method issues with the support of laboratory management
• Performs other duties, as assigned

Minimum Education and Experience Required:

• Associate degree in Life Science, Pharmaceutical, or related field with 4+ years of laboratory experience in a CGMP environment; or
• Bachelor’s degree in Life Science, Pharmaceutical, or related field with 2+ years of experience in a CGMP environment
• Experience with data management systems (e.g., LIMS, TrackWise)

Preferred Education and Experience:

• 4+ years of experience in a cGMP Microbiology laboratory

Knowledge, Skills and Abilities:

• Strong knowledge of aseptic techniques and behaviors
• Effective communication, both written and verbal
• Advanced technical writing and problem-solving skills
• Ability to complete work independently and with minimal supervision
• Ability to prioritize and organize work to deliver assignments according to established schedules and deadlines
• Ability to effectively collaborate with coworkers and internal clients
• In-depth understanding and knowledge of United States Pharmacopeia and European Pharmacopeia
• Ability to support audit readiness for the laboratory
• Ability to incorporate lean lab and six sigma principles into the work environment
• Ability to manage and complete tasks according to a structured plan
• Expertise with data management systems, such as TrackWise, LIMS, and capability to learn basic use and navigation within the systems
• Must be flexible to support 24/7 manufacturing facility

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS:
Will work in environment which may necessitate respiratory protection. X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. X No Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes

WORKING ENVIRONMENT
PHYSICAL DEMANDS:
Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. No X Yes 60-120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to sit for prolonged periods of time. No X Yes 60-120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments. No X Yes 2-8C Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_FDBU@fujifilm.com).