- GlaxoSmithKline PLC
- $81,640.00 -118,940.00/year*
759 Cornell Ave
MS and Characterization Scientist, US?
As an MS and Characterization Scientist you will be responsible for developing mass spec based strategies & methods (e.g. LC/MS and LC/MS/MS) and perform analysis for the characterization and comparability evaluation of complex therapeutic proteins including identification and quantification of product variants such as posttranslational modifications and product & process related impurities. The candidate is also expected to develop other analytical and/or biochemical methods and participate in testing for supporting of biopharmaceutical process development and manufacturing.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Provide high quality and responsive mass spectrometry capability to support product development and drug discovery activities across large and small molecules, with a specific expertise in large molecule mass spectrometry and characterization. Deliver structural characterization work packages to support the identification and patent protection of new chemical/biological matter, the identification of CQAs, the generation of control strategies for API and drug product, and the generation of structure function relationships. Work with all partners across PDS, BPDS, CMC Regulatory Affairs, and PSC to ensure on-time delivery of high-quality CMC packages for submissions or post-approval commitments that meet or exceed the expectations of external regulators and that lead to first-cycle approvals and assure supply chain robustness. Leading a team of 6-8, ensure that technical excellence is maintained within the team and that staff are developed to their fullest potentials by providing coaching, mentoring, and appropriate learning opportunities for staff. Ensure the robust technical and data review of the team s outputs. Ensure that external partners are delivering high-quality and timely results. Validate and then transfer methods to quality control groups in pharma supply chain to enable commercial manufacture and the launch of our products Implement a continuous improvement plan to ensure that activities performed by the group are in compliance with current regulatory expectations in the markets of interest and are at the leading edge of analytical sciences Ensure the work conducted by the group is performed in accordance with GSK and external regulatory quality standards in the markets of interest and is also conducted in accordance with GSK and local EH&S standards. Pro-actively manage laboratory and staff health and safety
Basic Qualifications: MS with more than 10 years or a Ph.D. with 0-3 years of experience in biotech or pharmaceutical industry. Extensive prior experience in LC/MS and LC/MS/MS analysis of protein therapeutics is a must, along with a sound understanding of protein structure and function relationships.
Preferred Qualifications: In-depth knowledge and hands-on experience in various protein separation and characterization techniques such as CE, cIEF, HPLC/UPLC and biophysical techniques would be a plus. Experience in supporting different stages of biopharmaceutical development would be highly desirable. The candidate is expected to be highly motivated with excellent communication skills, both written and verbal. She or he should be instinctive team player with excellent people skills.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness
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Associated topics: aseptic, bacteria, biopharma, diet, histotechnologist, immunology, injury, nephrology, nutritionist, virus
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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