JOB DESCRIPTION SUMMARY:
This Senior Scientist will be accountable and responsible for the development and qualification of on-line and at-line high throughput LC-MS based methods to support process development activities. In this role, the candidate will be part of a committed cross-function team dedicated to the implementation of process analytical technology (PAT) and Enhanced Process Control (EPC) strategies for next generation process development. The candidate will evaluate where existing and emerging MS-based techniques may replace existing off-line technologies to provide rapid analysis and shortened decision cycles for process development. Key areas of focus will be product quality assay development to monitor product attributes, including, but not limited to, clipping, misfolding, charge heterogeneity, oxidation, deamidation, sequence variants, and glycosylation. ESSENTIAL RESPONSIBILITIES:
1. Development and qualification of online and at-line high throughput MS-based assays for non-GMP processes. Approximately 50 % Time
2. Development and verification of automated data processing and reporting templates for MS based methodologies enabling on-demand access product quality data for adapative process control. Approximately 15 % Time
3. Collaborate with other process develoment functional areas to enable deployment of PAT and EPC strategies. Approximately 15 % Time
4. Devise technically sound protocols, execute DoE based method qualifications, author technical reports, author external publications, and provide internal as wel as external presentations. Approximately 15 % Time
5. Educate AD and PDTS staff on online and at line HTP MS-based methodologies. Approximately 5 % Time EDUCATION AND EXPERIENCE:
KNOWLEDGE, SKILLS AND ABILITY:
- Ph.D. in Analytical Chemistry, Biochemistry and Pharmaceutical or related discipline with a minimum of 3 years relevant Postdoctoral or industry experience in Mass Spectrometry and/or Process Analytical Technology.
- MS in Analytical Chemistry, Chemistry, Biochemistry and pharmaceutical or related discipline with a minimum of 6 years relevant industry experience in product and process development.
- BS in Analytical Chemistry, Chemistry, Biochemistry and pharmaceutical or related discipline with a minimum of 10 years relevant industry experience.
- Understands and applies advanced scientific principles, theories, concepts, practices and standards to process and product development. Keeps current with scientific knowledge in areas of expertise. Provides input to the development of new scientific knowledge.
- Expertise and demonstrated track record in mass spectrometry of biomolecules.
- In-depth knowledge of top-down, middle down, and bottom-up mass spectrometric methodologies.
- In-depth knowledge of mass spectrometric technologies including hardware and software tools.
- In addition to mass spectrometry, this candidate should have sound knowledge of chromatographic separation techniques (such as RP, SEC, and IEX,) and capillary electrophoretic techniques (CZE-LIF, CE-SDS, cIEF, and CE-MS).
- Independently guide method development and qualification activities.
- Designs and independently performs studies to troubleshoot issues encountered during development and qualification work.
- Documents and reviews data as per established company guidelines and SOPs. Authors documents such as protocols, memos, data summaries, reports and procedures and external publications.
- Presents issues and results at department and project team meetings. Presents at external meetings or publishes in peer-reviewed journals.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.