Raw Materials QC Manager

The Raw Materials QC Manager is accountable for GMP compliant laboratory operations according to GMP guidelines. This role is responsible for direct management and supervision of the QC Raw Materials teams performing raw material testing according to USP/EP/JP guideline and releasing raw materials for use in the drug substance and drug product manufacturing process. The Manager QC Raw Materials is responsible for managing raw material specifications handling changes from customers on customer owned materials as well as handling and implementing new raw materials and consumables as part of tech transfer activities. In addition the QC Raw Materials team is responsible for testing disposition and release of raw materials and Trackwise support or investigation of deviations including Out of Specification (OOS) results. Provide managerial support for troubleshooting of complex investigations and optimizing laboratory systems. Ensure that the laboratory is maintained in a state of GMP compliance. All documentation is in accordance with GMP and all reported results are accurate. The Manager QC Raw Materials is the technical subject matter expert (SME) and participates in assessing the testing of raw materials and excipients represents the QC Raw Materials team during regulatory and customer audits. The Manager models leadership competencies and aids in the development of QC team members.

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion energy and drive what FUJIFILM Diosynth Biotechnologies call Genki.

College Station Texas may be a small university town but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile radius so we are in the center of it all in Texas. And our site is nestled in the hub of innovation representing a source of pride for the area.

What Youll Do

• Ensures GMP compliant laboratory operations according to guidelines
• Manages the daily activities of the QC Raw material team and assuring dedicated focus on testing release change management and Tech Transfer activities in support of new and existing customer programs
• Ensures overall performance of QC Raw Material team according to KPIs. Assures turnaroundtimes of all testing raw material approvals and supporting drug substance and drug product manufacturing production.
• Oversees and manages laboratory exceptions and investigations and assures timely closure of cGMP KPI deliverables within the group
• Motivates the group to perform as efficiently as possible to reduce turnaroundtimes for testing approval and ensures manufacturing is running and tech transfer activities timelines are met
• Authors procedures documents and reports as needed to support the QC Raw Materials team and tech transfer activities
• Leads projects for tech transfers by having dialogues with customers around customer owned and FDB owned materials etc.
• Prioritizes and focuses on optimized laboratory systems including the use of IT systems (e.g. Labware) identifies and implements needed procedural and/or policy changes in areas where needed. Enforces established policies processes and procedures and identifies areas where enhancements will improve daily work
• Leads crossfunctional collaboration with QC Analytical Development QC Program Management Manufacturing Process Science and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives
• Authors reviews and approve data reports outofspecification (OOS) and outoftrend (OOT) investigations deviations CAPAs and Change Controls as needed
• Ensures the team and laboratory maintains inspection readiness for customer visits audits and regulatory inspections following cGMP guidelines and FUJIFILM Diosynth Biotechnologies processes
• Ensures the timely delivery of results within deadlines by effectively managing the performance of the QC Raw Material Team
• Represents QC in relevant internal and external crossfunctional meetings and projects to ensure delivery of QC Raw Material objectives
• Executes managerial tasks per the FUJIFILM Diosynth Biotechnologies policies including coaching guidance and development of team members
• Supports management activities related to compliance with policies appropriate personnel training providing feedback for personnel development and effective and timely decision making/corrective actions on the floor
• Performs other duties as assigned

Minimum Requirements:

• Bachelors degree with 8 years of experience in a GMP environment OR
• Masters Degree with 6 years of experience in GMP environment OR
• Ph.D. with 4 years of experience in GMP environment
• 5 years of experience with analytical testing preferably raw material testing and release
• Previous QC Raw Materials Management experience

Preferred Requirements:

• Masters degree or Ph.D. in Chemistry Microbiology Biological Sciences Engineering or related science degree with 6 years of GMP experience OR
• D. in Chemistry Microbiology Biological Sciences with 4 years of GMP experience
• Previous experience with analytical testing preferably raw material testing and release in the biopharmaceutical industry
• Experience with Microsoft Office Smartsheet and laboratory LIMS and ERP systems (e.g. SAP)

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the employee is regularly required to:

• Experience prolonged standing some bending stooping and stretching.
• Use handeye coordination and manual dexterity sufficient to operate a keyboard photocopier telephone calculator and other office equipment is required.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to chemicals gases fumes odors dusts and other hazardous materials.
• Ability to wear personal protective equipment including but not limited to safety glasses lab coat gloves specialized clothing including laboratory scrubs (pants and shirt) cleanroom (ISO 8 to ISO 5 gowning material and appropriate shoes required in most areas associated with this position.
• Must be willing to work flexible hours.
• Ability to lift up to 15 lbs regularly and up to 30 lbs on occasion.
• Ability to work weekends and offshift hours as needed to support manufacturing activities.
• Must be willing to travel occasionally as needed.
• Attendance is mandatory.

Join us! FDB is advancing tomorrows medicine impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers driven by an innate desire to better ourselves our families our workplace our company our community and the world at large.

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 viaemail 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 place. 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.

Fujifilm is committedto 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 preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department or.