Experience Inc. Jobs

QC Analytical Tech Associate Director

Job LocationsUS-TX-College Station Posted Date3 weeks ago(8/5/2024 11:39 AM)

Requisition ID

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: 2024-27637

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Category

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: Quality Control

Company (Portal Searching)

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: FUJIFILM Diosynth Biotechnologies

Overview

The work we do at FDB 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, mission-driven 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 FDB 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 small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile 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.

Summary:

The Associate Director of Quality Control Analytical Tech is responsible for directing and overseeing analytical development activities and method transfer activities in support of process development and manufacturing. Additionally, responsible for the oversight of key functional, strategic, tactical, and operational aspects of the Analytical Tech department at FUJIFILM Diosynth Biotechnologies Texas. This includes raw materials, in-process testing, drug substance and drug product testing and includes author/review transfer plans, method transfer documents, transfer summary reports and specification justificiation reports. Additionally, monitor progress and provide status updates. The Associate Director will also oversee and drive development and incorporation of automation, as appropriate, and facilitate transfer of those assays, as appropriate, to QC. The Associate Director will liaise with Contract Laboratory Organizations, QC testing teams, QA, Manufacturing Science groups to ensure prioritization of non-compendial and compendial method transfer activities according to deadlines. Coordinate analytical tech activities, e.g. assessment activities for change controls for the implementation of new raw materials, transfer of methods, specifications update, e.g. expiry changes and new vendors.

External US

Essential Functions:

• Plan and deliver high throughput, high quality, GMP compliant and scientifically sound QC activities to support Biologic manufacturing and ASG activities for clients at all phases for drug substance and drug product where applicable.
• Ensure QC activities take place in line with Sales and Operations business milestones, provide timely identification and escalation of at risk milestones using business tools (eg: Gantt charts, trackers, risk assessments, etc) and drive remediation or mitigation.
• Manage the QCAT department which includes planning, goals setting, oversee employees assuring these individuals understand their duties and responsibilities, providing direction, give feedback, perform evaluations of their performance, and assist in growth development.
• Engage in new employee hiring and ensure that business goals, deadlines and performance standards are met.
• Responsible for the training and safety of all employees in the team and proactively keep an eye out for safety issues.
• Identify, evaluate, develop, and implement new analytical technologies and strategies leading to process improvements and operational efficiency.
• Perform Subject Matter Expert (SME) activities such as review of relevant SOPs, t ansfer plan, protocols, reports, transfer summary report and justification specification report.
• Ensure compendial method oversight and scientific guidelines, e.g., ICH, EMA, FDA, etc.
• Support SMEs in regulatory requests and inspections, directly interacting with regulatory agencies.
• Address highly complex analytical problems and prioritize work and activities to give overall direction and strategy for the QC testing team in collaboration with Texas QC core management.
• Make decisions regarding quality issues, complex investigations, resources like instruments, equipment, and staff.
• Provide guidance on setting strategy for the QCAT departments together with QC core management, and prepare for the growth of the organization.
• Lead or aid complex investigations and manage the reporting of out-of-specification results and deviations, ensuring that the correct pace is set and using appropriate tools (eg: fishbone, RCA, etc) to ultimately deliver meaningful CAPA.
• Keeps QC laboratories and QC systems inspection ready.
• Maintain the Quality Management Systems to ensure Compliance and Quality actions are in control.
• Oversees and coordinates laboratory activities supporting product testing, method qualifications, and tech transfer activities.
• Participates in customer and regulatory audits as needed
• All other duties as assigned.

Required Skills and Abilities:

• Demonstrated leadership skills
• Excellent people management and coaching skills
• Extensive knowledge within analytical testing of proteins
• Extensive understanding of GMP guidelines
• Excellet verbal and written communication skills
• Technical expertise in raw materials, protein characterization, release and stability assays for biologies (e.g. titer, aggregation, impurity, content, potency testing with underlying methodologies of U/HPLC, CE-SDS, HPLC-MS, UV-VIS, ELISA, cell-based assays, rtPCR).
• Demonstrated application and knowledge of ICH guidelines on analytical method validation and transfers including statistical experimental design and data analysis with JMP software, stability indicating attributes for protein biotechnology products.
• Strong customer focus and ability to prioritize and adapt to business needs
• Demonstrated ability to interpret and implement GMPs, regulations and company policies.
• Thorough understanding of laboratory operations and manufacturing processes.
• Strong organizational skills.
• Detail oriented and accurate.
• Ability to multi-task and prioritize work assignments with little supervision.

Working Conditions and 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 sitting, some bending, stooping and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Attendance is mandatory.

Qualifications:

Masters Degree preferably in Chemistry, Biotechnology, Microbiology, or other related science discipline and 8 years of experience with analytical testing, preferably in a AD/QC laboratory setting

Bachelors Degree preferably in Chemistry, Biotechnology,