QC Analytical Technologies Senior Scientist, Microbiology

Employer
CSL Behring
Location
Kankakee, Illinois
Posted
Nov 24, 2021
Ref
R-148957
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
Job Description

The QC Analytical Technology Senior Scientist is an established subject matter expert and independently develops projects and investigation study plans to meet QCAT deliverables. Taking project management responsibility for QCAT deliverables of moderate to high complexity, the QC Analytical Technology Senior Scientist develops and coordinates the experimental and documentation requirements necessary to meet the established milestones.

Responsibilities:
• Stay current with cGMP training as required to maintain compliance with CSL quality and regulatory commitments.

• Follow CSL documentation and data integrity requirements associated with generation, review and reporting of cGMP activities.

• Responsible for ensuring thatall activities performed and led are undertaken in compliance with associated SOPs, procedures, test plans and protocols as appropriate.
• Provides expertise in investigation of deviations, atypical results and method performance issues as a subject matter expert and leads the execution of appropriate testing and interpretation of analytical results.
• Manages the development of project plans including estimated cost,time and resourcesfor the identified work activities. Responsible for the oversight and management of moderate to large, complex projects that may be require global project management.
• Manages projects, investigations, regulatory submissions and during audits and inspections as a technical and subject matter expert.
• Lead the remediation of analytical challenges within CSL QC through method improvements, as well as development and implementation of new methods and innovative technologies.
• Lead the development, qualification, validation and transfer of methods between R&D, QC and external laboratories as required.

Qualifications:
• BS/BA in Engineering, Physical, or Biological Science or other appropriate technical fields (Masters or Doctoral degree is preferred).
• A minimum of 3 years experience in cGMP Quality Control and at least 2 years experience in method development for assessment of biological pharmaceutical products

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