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Employer Pe Global
Job Title Technical Specialist - Downstream
Description

PE Global are currently recruiting for a Technical Services Specialist - Downstream for a client site in West Dublin -

Duties:

The Purification (Downstream) Technical Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) at client’s facility in Dublin.

The Technical Specialist will provide protein purification processing expertise to support the facility design, start-up and routine commercial manufacturing for chromatography, UFDF/TFF filtration, Viral filtration technologies and bulk fill unit operations respectively.

The Technical Specialist will be responsible for providing support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility startup and process qualification.

The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Process Owner for cell culture unit operations, Process Validation (PPQ), Process Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability.

Principal Responsibilities

  • To provide process expertise in the area of buffer preparation, large scale protein purification drug substance manufacturing process (column chromatography, VI, UFDF/TFF, Viral filtration and bulk fill) to support the successful startup of client’s BDS facility in Dublin.
  • Working knowledge of typical chromatography and filtration unit operations and functional purpose, cause and effect, in-process tests, and mass balance principles.
  • To author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents.
  • To identify requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development to oversee the design and execution of studies.
  • To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements.
  • To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
  • To identify and implement process improvements; e.g. yield, cycle time reduction.
  • To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
  • May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution.
  • To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution.
  • Lead any key process changes using change control management system.
  • Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
  • Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations.
  • To author and review IND, BLA and other technical documents for regulatory agency submissions.
  • To serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections.

Skills:

  • Minimum 3+ years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization.
  • Technical and operational knowledge of multiple unit operations in downstream protein purification processing.
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
  • Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings.
  • Ability to present and defend technical and scientific approaches in both written and verbal form.
  • Ability to drive for results independently and adapt to rapidly changing priorities
  • Experience of authoring CMC sections of regulatory submissions would be advantageous.
  • Experience of Technology Transfer activities is advantageous.
  • Experience of disposable technology would be advantageous.
  • Knowledge or experience of start-up or systems would be ideal.
  • Detail orientated.
  • Technical writing competency.

Education:

  • Minimum requirement of B.Sc in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
Interested Candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900

This job originally appeared on RecruitIreland.com
Location Dublin
Date Added 7 days ago
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