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Job Opportunity

Job Opportunity
QC Microbiology Senior Scientist
Mar 31, 2021
QC Microbiology Senior Scientist
Ireland Dundalk
Dundalk, Ireland
major responsibilities:

Job Summary

 

The Senior Scientist will be leading various technical projects/activities in the QC Microbiology Group of WuXi Biologics. The site is focused on start-up activities involving commissioning and qualification work with aggressive timelines and potential candidates are required to be flexible in this regard. This also means that potential candidates may be required to carry out additional job functions that are not described in this job description but will be associated with the role.

 

Essential Duties and Responsibilities

Specific Start up activities:

  • Ensure the tasks associated with the start-up and routine operations of a QC microbiology laboratory are carried out in a safe manner.
  • Support QC Microbiology lab set-up, including laboratory design and construction queries, equipment installation and qualification utilizing principles of Operational Excellence and Lean Labs.
  • Microbial organism identification, supporting facility qualification, cleaning validation, process validation, etc.
  • Develop and maintain quality systems within the QC Microbiology Laboratory to ensure compliance to cGLP.
  • Support of the commissioning/qualification activities of utility systems including but not limited to Water systems, Clean Steam and process gases, including development of sampling strategies.
  • Aiding in the identification and development of Contract Test laboratories and strategies.
  • Development of training material for the QC Microbiology Laboratory personnel.
  • Support and lead microbial method validation and development of routine testing strategies.

 

           Sustaining operations:

  • Lead QC microbiology routine testing, environmental monitoring, water monitoring, and testing including, sterility, endotoxin, bioburden, Biological Indicators, Growth promotion and routine microbial identification strategies.
  • Routine monitoring of laboratory KPI’s, stock control of laboratory consumables and reagents and support for future expansion/upgrade projects. 
  • Serve as a technical expert to lead OOS, OOL, microbial contamination, adverse trends, utility and environmental excursion investigations, change controls, and CAPAs.
  • Author technical documents including methods protocols, qualification/ validation protocols and reports, SOPs, etc.
  • Support Risk Assessments for projects and business innovation initiatives from a microbiological perspective.
  • Defines specific aseptic techniques to be performed for crucial process steps and provides meaningful input to processing operations as site develops.
  • Keep abreast of current corporate and regulatory trends and requirements pertaining to laboratory operations and aseptic manufacturing.
  • Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development.
  • Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.
  • Ability to handle regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as well as internal audits.
  • Participate in relevant internal and external QC related audits.
  • Ability to work in a team environment and independently as required
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics Policies and Standard Operating Procedures.
  • Thorough understanding of current Good Manufacturing Practices
  • Other duties as assigned

 

qualifications requirements:

Person Specification

 

Technical Competencies

  • Possesses detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
  • Familiarity with Pharmacopeia testing methods and requirements. 
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines is a plus.
  • Experience with regulatory/customer audits is a plus.

Experience

  • Management/supervision of personnel with particular attention to schedules and shifting priorities.
  • Training/coaching of personnel.
  • Experience with direct manangement of staff is a plus.
  • Previous experience in a Quality Control/GMP environment is required.

Knowledge

  • Knowledge of microbial testing and microbial control in support of biopharmaceutical manufacturing is preferred but not required.

Qualifications

  • Ph.D. with/without post doc experience or MS in Microbiology or related field is a plus.
  • Minimum of a honors science degree in a related field with strong relevant experience is essential.

 

Behavioural Competencies

  • Ability to think critically and demonstrate troubleshooting and problem solving skills
  • Excellent interpersonal, verbal, and written communication skills
  • Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities.

Other Considerations.

Shift work and business travel may be required for this position as directed by departmental manangement

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