QC Analytical Tech Associate Director

1 week ago

TX United States Fujifilm Full time
Job Title: Associate Director of Quality Control Analytical Tech

Fujifilm Diosynth Biotechnologies is seeking an experienced Associate Director of Quality Control Analytical Tech to join our team in College Station, Texas. As a key member of our Quality Control department, you will be responsible for directing and overseeing analytical development activities and method transfer activities in support of process development and manufacturing.

Key Responsibilities:
  • 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 & 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 SOP's, transfer plan, protocols, reports, transfer summary report and justification specification report.
  • Ensure compendial method oversight and scientific guidelines, e.g., ICH, EMA, FDA, etc.
  • Support SME's 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.
Requirements:
  • 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 & 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:
  • Master's 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
  • Bachelor's Degree preferably in Chemistry, Biotechnology, Microbiology, or other related science discipline and 10 years of experience with analytical testing, preferably in a AD/QC laboratory setting
  • 4 years of managerial experience
  • 5 years must be in a GMP/ISO regulated laboratory
Preferred Qualifications:
  • Advanced degree
  • Experience in Gene Therapy and monoclonal antibody testing

Fujifilm Diosynth Biotechnologies is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law. If an accommodation to the application process is needed, please email or call.

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 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.

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