- Reference: GJ42294AO
- Job Type: Permanent
- Location: Limerick, Limerick city
- Category: Bio-Pharmaceutical
Associate Manager Process Sciences- Limerick
The successful candidate will lead a team to manage all activities to ensure that manufacturing processes are supported. Responsible for supporting the Process Sciences Department through Technology Transfer both internally and externally, technical evaluations and Process Validation.
- Assess manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities.
- Provide manufacturing descriptions and technical evaluations for regulatory filings and inspections.
- Communicate information on current process data & other IOPS initiatives which may impact PD and/or technology transfer.
- Provide technical support for manufacturing personnel to improve understanding of both cell culture and purification operations.
- Gather, trend, and analyse process generated data, create process evaluation reports and process transfer documentation.
- Lead/ Support external product transfers through technical expertise and person on plant activities.
- Write, review and approve Process Validation protocols and reports.
- Identification of process parameters and appropriate ranges to be included in validation
- Provide on the floor support to Manufacturing (Cell culture and Purification) during PV campaigns.
- Provide information for manufacturing documentation such as manufacturing records, SOPs and batch sheets.
- Develop validation procedures reflecting best practices and provide on the floor support & oversight during process validation campaigns
- Serves as a subject matter expert (SME) for Process Validation.
- Support the site through regulatory audits by providing technical expertise.
- Work efficiently and effectively in a fast paced team-oriented environment to ensure maximum and high-quality output.
- Lead a team and manage all activities to assure that manufacturing processes are supported.
Skills, Experience and Qualifications:
- Requires a Bachelors degree in a related field with 5-8 years of related experience in a GMP environment.
- Strong technical experience in biological drug substance (DS) mfg. with a focus on Process Validation and Technology Transfer activities.
For a confidential discussion and more information on the role/company please contact Amy O’Neill on 091-706718 or email email@example.com
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