Method Qualification Manager

Essential Functions:

  • Demonstrates expertise in the design, execution and management of qualification/validation/verification/technical transfer of a broad range of analytical methods for release and in-process cGMP testing of therapeutic proteins and gene therapy products.   Special emphasis on chromatography, capillary/traditional electrophoresis, spectrophotometry, and plate based colorimetric methods to support cGMP manufacturing of biopharmaceutical products.
  • Thorough understanding and implementation of ICH Q2R1 Validation of Analytical Procedures: Text and Methodology.  Experience in authoring and reviewing qualification / validation protocols and reports.
  • Work globally with FDB Analytical Development Departments to assist in protocol and report generation, data evaluation, and troubleshooting analytical method deficiencies during cross site transfers.
  • Participate and collaborate globally to harmonize protocols and reports across all three FDB sites.
  • Experience in training junior analysts in conducting method transfers and method qualifications with a proven understanding of developing a QC knowledge base in this area of expertise.
  • Work collaboratively with the area QC managers to allocate resources properly to meet the dynamic schedules of multiple parallel programs supporting method qualification, release, and stability testing.  Assist and conduct project planning, including timing and execution of deliverables to meet established milestones.
  • Experience working in a contract manufacturing or testing organization.  Attend project team meetings as needed, to include customer updates.
  • Demonstrates communication and interpersonal skills, including confident presentation of data, positive and lasting collaboration with colleagues across departments and FDB sites, forging positive relationships with external clients, the ability and confidence to challenge others when necessary and strong problem solving skills.
  • Experience creating and managing efficiency improvement initiatives within a team
  • Experience working in a regulated cGMP environment
  • Excellent oral and written communication skills as well as demonstrated expertise with Microsoft Excel, Project, Word and Google docs

Required Skills & Abilities:

  • Have broad technical competence across biochemistry, chromatography, and bioassay disciplines to enable swift resolution of technical and scientific challenges and manage meeting deliverables internally and externally.
  • Sound understanding of analytical instrumentation and methodologies.
  • Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
  • Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
  • Ability to multi-task and prioritize work assignments with little supervision.
  • Excellent attention to detail.
  • Computer proficiency required.
  • Ability to accurately review and complete required documentation.
  • Excellent written and oral communication skills.
  • Excellent organization and analytical skills.

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 hand-eye 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 hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
  • Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.
  • Attendance is mandatory.

Minimum Qualifications:

  • Bachelor of Science degree with at least six (6) years’ industry experience in a GMP / GxP, or a comparable federally regulated environment, of which two (2) years are in a supervisory or managerial role.

Preferred Qualifications:

  • Chemistry or Biochemistry major.
  • Analytical laboratory experience in a GLP/GMP regulated environment is preferred.
  • Experience in Systems, Applications and Products (SAP) software.
  • Experience in Trackwise Deviation Management software.

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