Manufacturing Supervisor / Team Leader (Biologics)

2022-07-13 10:14:232049-12-30Team Horizon
Job TypePermanent
AreaSligoSligoIreland
SectorEngineering
Start Date
AdvertiserEsther Emmanuel
Telephone+3539833033
Job Ref#1002546
Job Views142
Description
Manufacturing Supervisor / Team Leader (Biologics) – Team Horizon
 
Team Horizon currently has an exciting opening for a Technical Shift Lead (Biologics) for our client who are a global leader in the Biopharmaceutical Industry.
Reporting directly to the Operations Lead, you will be lead, and coach your team and be responsible for producing biologics fill finish materials as per organizational needs in line with all relevant safety and quality compliance requirements.

Why you should apply:
  • Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
  • The role is generously compensated and attracts a competitive base salary and benefits package.
  • Our client is forward thinking and pride themselves in excellence, both through their people and quality and dedication of customer care teams.
 
What you will bedoing:
  • Lead, coach, and mentor your team.
  • Be responsible for the supervision and execution of filling, lyophilization, equipment preparation, formulation, buffer preparation and support processing activities in the biologics fill finish facility to meet clearly stated operating objectives.
  • Promote a culture of contamination control and compliance with aseptic best practice.
  • Liaise with functional leadership teams (Ops, Quality, Engineering, Supply Chain etc) on operational activities
  • Daily reporting on the status of all operations and support activities.
  • Provide clear and concise communication to your team on their tasks and goals so that they can work effectively.
  • Provide technical expertise for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review, and approval of change controls
  • Responsible for verification and update of manufacturing control system transactions accurately and in a timely fashion.
  • Act as key point of technical contact for aseptic fill finish activities. 
  • Liaise with program management, supply chain, technical operations quality, and engineering groups to ensure effective planning, scheduling, and execution of commercial and NPI clinical manufacturing.
  • Responsible for driving operations excellences and Key operations targets including OEE where applicable.
  • Provide direct interface as a subject matter expert with QA department to interaction with HPRA, FDA and applicable health authority and internal audits.
  • Lead cross functional risk assessments and continuous improvement projects
  • Ensure the execution of fill finish, lyophilization, equipment preparation, buffer preparation and formulation processing activities to meet clearly stated operating objectives.
  • Responsible for manufacturing compliance with all safety, environmental and quality related SOPs.
  • Drive safety improvements and initiatives across the operation
  • Promote a culture of Right First Time, Behavioural Based Safety, Always Audit Ready and Human Error Reduction within their team.
  • Work closely with the other Technical Shift Leaders to ensure interdepartmental activities are planned and executed safely.

What you need to apply:
  • Degree, Masters or PhD in Life Sciences, Process Engineering, Biopharmaceutical Engineering or Chemical Engineering discipline desirable.
  • With 3 + years’ experience in batch processing, automation, commissioning, and validation in an FDA/HPRA regulated industry and 1+ years team leadership experience
  • Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
  • Comprehensive understanding of the principles of contamination control and regulatory expectations for aseptic processing.
  • Has a technical background in pharmaceutical, biologics, or similar industries?
  • Experience of start-ups and/or new product introductions to bio-pharmaceutical/pharmaceutical facilities (Biologics Preferred)
  • Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality and safety requirements.
 
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