ANALYTICAL PRODUCT LEADER, TECHNICAL R&D
- Rockville, MD
Site Name: USA - Maryland - Rockville
Posted Date: Aug 20 2020
Within the Analytical R&D group, the Analytical Product Leader will be in charge of managing and implementing the global analytical strategy of her/his products portfolio (2-4 projects), in alignment with the GSK Vaccines R&D and TRD strategies, and in accordance with Quality by Design (QbD) principles.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Deliver and implement the consolidated global analytical strategy of her/his products portfolio (2-4 projects), in alignment with the GSK Vaccines R&D and TRD strategies, and in accordance with Quality by Design (QbD) principles.
- Influence the success of Analytical Technical Development by being one voice of ARD with TDT, RA and QC from early through late stage and life-cycle management.
- Accountable for the methods development according to the Analytical Target Profile (responsibility for SM Dev) and the GMP release and stability testing plan, through both the Analytical Development platforms and the GMP unit.
- Manage the product understanding (characterization) of clinical (phase 1-2 and Phase 3) and commercial products and LCM (highly specialized platform)
- Manage the analytical support to process understanding (antigen and product characterization needs) with other TRD functions using state of the art technologies for analytics and data interpretation
- Manage the critical material and reagents strategy and ensure their availability in due time
- Raise and manage any risk/issues on critical path to TDT and to ARD functions (budget, capacity, technical)
- Managing and implementing the global analytical strategy of her/his products portfolio (2-4 projects), in alignment with the GSK Vaccines R&D and TRD strategies, and in accordance with Quality by Design (QbD) principles.
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)
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.
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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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