Associate Manager – Process Sciences
This innovative specialty biotech organisation is a leading science-based biopharmaceutical company based in the U.S that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. This organisation commercializes medicines for eye diseases and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia,oncology, rheumatoid arthritis, asthma, and atopic dermatitis. Employing north of 4,000 staff globally with annual R&D spend of $1 billion, this organisation is consistently being voted one of the top innovative biotech organisations globally year on year.
- Lead a team and manage all activities to assure that manufacturing processes are supported.
- Responsible for developing a team such as development plans, upskilling and team forming.
- Write, review and approve Process Validation protocols and reports.
- Identification of process parameters and appropriate ranges to be included in process validation.
- Provide on the floor support to Manufacturing (Cell culture and Purification)
- Lead/Participate Process and Quality risk assessments.
- Lead troubleshooting activities associated with the manufacturing process.
- Provide technical support for manufacturing personnel to improve understanding of both cell culture and purification operations.
- Review and approve manufacturing documentation such as manufacturing records, SOPs and batch sheets.
- Develops/writes/plans and reviews protocols and activities for manufacturing support.
- Serves as a subject matter expert (SME) for data trending and manufacturing support.
- Presents and reviews process monitoring data to IOPS Management as necessary.
- Investigates and reviews OOS and OOL IPCs investigations.
- Performs, reviews and approves product impact assessment.
- Performs, reviews and approves scientific investigations (EOE & DNF).
- Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer.
- 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.
- Requires a Bachelors degree in a related field with 10+, a Masters with 5-8 years or PhD with 3-5 years of related experience in a GMP environment. Ideal candidate has experience in biological drug substance (DS) manufacturing.
To learn more apply on line or call Shane Browne on +353 1 6321865.
Salary: On Application