What Youll Do
- Provides day-to-day supervision and scheduling of the QC Microbiology laboratory team
- Applies expertise in laboratory methodology and compendial requirements for QC Microbiology testing and acts as primary point of contact for their team and first-line escalation point in areas of their responsibility
- Leads team to meet project deliverables
- Demonstrates ability to set up and maintain operations of a QC Microbiology laboratory
- Assists senior management with resource planning and budget-related tasks
- Ensures efficient team scheduling management of sample collection and testing to meet deliverables on time
- Gathers recommendations for enhancements and gaps related to their areas of responsibility and in collaboration with leadership prioritizes and implements solutions accordingly
- Maintains relationships with site-based customers and global colleagues and provides updates to leadership as requested
- Ensures allocation and planning of adequate resources for laboratory testing activities QA support activities and provides technical guidance to the team
- Leads cross-functional teams to achieve operational readiness objectives and new product introduction goals using a risk-based right-size approach
- Leads or guides laboratory staff in the investigation of lab deviations excursions and implementation of CAPAs as needed
- Serves as Subject Matter Expert (SME) in audits and inspections for the laboratory. Prepares and guides laboratory team to ensure audit readiness
- Establishes and maintains internal and external training goals for self and team to ensure compliance with cGMPs and regulatory requirements
- Provides training coaching and mentorship to their team and peers as applicable. Works with their team to identify areas of improvement reduce blind spots and give opportunities for increasing responsibility as appropriate for each individuals career objectives
- Administers company policies such as time off shift work and inclement weather that directly impact employees
- Completes required administrative tasks (e.g. timecard approvals time off approvals expense reports etc.)
- Coaches and guides direct reports to foster professional development
- Participates in the recruitment process and retention strategies to attract and retain talent as needed
- Addresses performance gaps employee questions and concerns and partners with HR as needed for resolution
- Performs other duties as assigned
Minimum Requirements:
- Bachelors in Life Sciences (Biology or Microbiology) with 4 years of relevant experience OR
- Masters in Life Sciences (Biology or Microbiology) with 2 years of relevant experience
- 2-3 years of people management experience
- Experience working in a regulated GMP environment
- Experience and working knowledge of LIMS Smartsheet Track wise Master Control and/or Kneat validation software
- Experience with management of complex projects
- Experience and understanding of compendial microbial methods Data Integrity and application of regulatory requirements for QC Microbiology
- Experience with laboratory equipment utilities qualification environmental monitoring qualification quality systems automation IT systems and/or validation of methodologies
Preferred Requirements:
- Experience leading teams in a laboratory setting
- Experience and advanced understanding of large-scale biomanufacturing processes
- Experience in leading startup activities and program-forming initiatives e.g. creation of systems or business processes that support Quality objectives
- Experience and familiarity with Technology Transfer and/or Product Commercialization processes
Physical and Work Environment Requirements:
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. No X Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. No Yes X
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color. No X Yes
Ability to ascend or descend ladders scaffolding ramps etc. X No Yes
Ability to stand for prolonged periods of time. No X Yes Daily for up to 60 minutes (If yes may specify frequency/duration: up tominutes)
Ability to sit for prolonged periods of time. No X Yes Daily for up to 60 minutes (If yes may specify frequency/duration: up tominutes)
Ability to conduct activities using repetitive motions that include writs hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. X No 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 Will work in warm/cold environments X No Yes 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
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To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.
Job Location:
Monthly Salary:
Not Disclosed
Posted on:
16 hours ago
Vacancies:
1 Vacancy
