Job Title: Upstream or Downstream Technical Services Specialist
The primary responsibility of the Technical Services Specialist is to support the cGMP manufacture of biological bulk drug substance (BDS) at our client's Dublin facility.
Key Responsibilities:
* Provide processing expertise for routine commercial manufacturing, technology transfer, and process validation in Downstream manufacturing of new/existing drug substance (DS) manufacturing processes.
* Collaborate closely with Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory, and other involved departments to ensure successful process support.
* Develop strategies and build SME capability in areas such as Downstream Purification unit operations, Process Validation (PPQ), Process Monitoring, Risk Assessment (using QRM tools), and building strategies.
Requirements:
* Bachelor's degree in Biochemistry, Biology, Chemistry, or equivalent, or B.Eng. in Process or Chemical Engineering.
* Minimum 3+ years of 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 processing.
* Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
* Excellent interpersonal skills and ability to work effectively in a matrix organization and local group settings.
What You Will Be Doing:
* Providing process expertise in one or both of the following disciplines: Upstream (Cell culture focus) or Downstream.
* Authoring and reviewing process transfer documentation, gap assessments, technical protocols, reports, and process validation documentation, strategy documents.
* Identifying requirements for laboratory studies to support process fit, decisions, or process transfer, and liaising closely with Global Process Development and CMOs to oversee the design and execution of studies.
* Supporting the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications, and outline testing requirements.
Working Environment:
May be required to work periodically out of normal business hours during periods of engineering and validation batch execution and provide on-call support to manufacturing.