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Are you looking for an impactful role that leverages your technical expertise and ability to build exceptional relationships with trusted global partners to develop an increased number of transformative medicines for our patients? If so, this Manager, Analytical Development role in a rapidly growing, empowered, innovative and agile Strategic External Development organization developing transformative medicines within a vibrant GSK hub could be an ideal opportunity to explore.
As a Manager, Analytical Development, you will contribute to internal and external development of the company's specialty drug products and/or development of SED's internal processes.
We are seeking an experienced manager/SME supporting development and registration of GSK's pipeline of preclinical and development-stage candidates. Develop analytical strategies for integrated early and late stage development activities in support of new product commercialization. Will be a part of a team for the generation of high-quality, on-time, and right-the-first-time data that comprise a critical component of regulatory submissions required to enable the clinical and/or commercial use of GSK products. The analytical data generated by these methods ultimately ensure the safe and effective use of our drug products in healthy volunteers and/or patients and ensure the continuity of supply of these drugs to patients.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Why you? Basic Qualifications:
- Manage and oversee analytical activities performed at CROs/CDMOs associated with method development, qualification/validation, transfer and characterization for drug substance, drug product and reference standards.
- Execute the strategies for product characterization with a focus on CQA assessment, and lead characterization activities at CROs/CDMOs.
- Collaborate with process and quality functions to ensure strong cross functional collaborations and integrated process and product development and characterization.
- Author, review and/or approve key documents such as: comparability protocols and reports, and relevant sections of regulatory filings (IND, IMPD, NDA, BLA, etc.).
- Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards.
- Implement processes to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results.
- Partner with GMP/GDP Quality Assurance and Regulatory Affairs-CMC to ensure completion of appropriate documentation and maintenance of high quality standards.
We are looking for professionals with these required skills to achieve our goals:
- M.S. in chemistry, biology, biochemistry, or related technical discipline
- 5 years experience in biopharmaceutical analytical development with small molecule, oligonucleotide, mRNA, monoclonal antibody and/or antibody-drug conjugate modalities and exposure to all stages of drug development
- Experience with analytical method development, validation and transfer
- Experience in the biopharmaceutical industry with relevant experience in late stage product, CQA assessment
- Approximately 10-15% domestic and international travel is anticipated
If you have the following characteristics, it would be a plus:
- PhD in chemistry, biology, biochemistry, or related technical discipline
- Ability to work in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities; must be able to work well in “gray space”
- Theoretical and hands-on knowledge and experience with characterization methodologies for drug substance and drug product
- Demonstrated experience and knowledge in tech transfer of methods and life cycle management
- Experience with antibody-drug conjugates (ADCs), bispecifics
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.
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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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