The Technical Specialist, will be responsible for providing scientific and technical support of drug substance manufacturing processes. The successful candidate will be responsible for providing scientific and technical support through all phases of the product lifecycle, including technology transfer, scale-up, process validation and continual improvement initiatives.
Duties and Responsibilities
- Assist with the configuration and qualification of large-scale BDS facilities, including NPI tech transfer and PPQ validation.
- Provide SME support for audit topics in the area of large scale cell culture and downstream purification processes, and participate in Tech Transfer Receiving Unit activities.
- Provide scientific and technical input to facilitate decision making related to Tech Transfer.
- Identify technical issues, and guide resolution of same.
- Provide expertise and knowledge on manufacturing processing (upstream/downstream), cause-and-effect, scale-up principles, and QRM, as well as strategies for process validation.
- Ensure that site manufacturing processes are robust and scientifically sound, keeping up with regulatory changes and industry trends.
- Engage with internal partners on pipeline processes.
- Perform risk assessments to support the technology transfer
- Technical support of Manufacturing Operations by investigating and resolving deviations, CAPAs, and reviewing and approving change controls.
- 3+ years experience working in pharmaceutical manufacturing, with expertise in Bulk Drug Substance and NPI Technology Transfer.
- A degree in chemistry, biology, engineering or related discipline.
- An advanced degree in a Scientific or Engineering related field desirable.
- Expertise in centrifugation, depth filtration, and cell culture processing.
- Understanding of analytical methods and corresponding signals.
- Thorough knowledge of bioreactor scale-up process or scaling principles for downstream operations.
- Understanding of cGMP requirements for commercial biopharmaceutical manufacturing.
- Experience of Validation/ Verification of GMP equipment/ processes beneficial.
- Strong interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment.
Milestone Solutions is a dedicated consultancy providing industry solutions to the Life Sciences, Discrete Manufacturing, FMCG and Chemical Processing industries; for more information go to www.mile.ie