CMC Analytical Leader, Technical R&D
- Rockville, MD
Site Name: USA - Maryland - Rockville
Posted Date: Nov 12 2020
Within the Analytical R&D group, the CMC Analytical Leader is accountable of definition and implementation of the analytical strategy of her/his products portfolio (2-4 projects), in alignment with the product CMC strategy and GSK Vaccines R&D strategies, and in accordance with Quality by Design (QbD) principles.
This role will provide YOU the opportunity to play a central leadership role within CMC development team and to progress YOUR career. These responsibilities include some of the following:
- Lead the CMC Analytical Technical Development Team to deliver and implement the consolidated global analytical strategy of her/his products portfolio (2-4 projects)
- Lead interaction of the global Analytical R&D function with all the other CMC functions (drug substance development, drug product development, regulatory, quality) in the CMC technical development team from early through late stage and life-cycle management.
- Accountable for stability testing plan
- Accountable for required assay transfer during development and to QC prior to registration
- Accountable for the analytical strategy to support process development and process understanding
- Accountable to define the critical material and reagents strategy and ensure their availability in due time
- Raise and manage any risk/issues (budget, capacity, technical)on critical path to CMC technical development team and analytical technical functions
Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- Ph.D. or equivalent in biological, analytical , or pharmaceutical chemistry, or similar field.
- Analytical Chemistry/Biochemistry
- Minimum 5 years experience in analytical development and product characterization of recombinant proteins, monoclonal antibodies, fusion proteins, conjugates and/or vaccines drug candidates.
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- Experience in technology transfer in manufacturing is a plus.
- Must have the ability to work with cross-functional teams and communicate effectively.
- Fluent English knowledge is a must (collaboration in international environment, conferences etc)
- Strong communication and influencing skills within Global Analytical group (Analytical Development platforms, GMP Testing, Operation Support) and outside (TDL, DS, DP, RA, QC, QA)
Why GSK? Our values and expectationsare 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:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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