GSK

Director, Large Molecule Analytical Development

Employer
GSK
Location
Waltham, MA
Salary
Competitive
Posted
August 30 2021
Ref
297900
Organization Type
Pharma
We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients, join us! Click to know more about GSK Biopharm. #GSKBiopharm_Development Director, Large Molecule Analytical Development will lead a team of US-based, globally oriented analytical experts in oversight of externalized development, validation and transfer of analytical methods for new large molecule (mAb) assets under GSK Strategic External Development oversight. Accountability: Director, Large Molecule, Analytical Development will lead a group of internal and external analytical team members accountable for the development, use, and validation of robust drug substance and/or drug product analytical methodologies, establishment and justification of associated specifications for a broad range of large molecules. Director, Analytical Development will be accountable for the provision of high quality scientific contribution to support portfolio progression from early to late phase project development including input to regulatory files (IND, IMPD, BLA, MAA, etc.). The job holder is accountable for the generation of critical data to support control strategies to ensure quality safe medicines reach all our patients; for the delivery of excellence in quality analytical method, data and knowledge to enable key decisions during development and technology transfer of methods. Director, Analytical Development will provide leadership to the team, including the development of scientific capability in core areas. Additionally, the job holder is accountable for oversight of analytical activities performed by external partners. Key Responsibilities: Build and maintain strong relationships with internal and external partners to ensure successful analytical strategies are positioned and implemented for the pipeline molecules in the Strategic External Development organization. Provide leadership, guidance, and strategic direction to a group of analytical scientists on all aspects of analytics for all projects residing within the group and ensure staff are developed to their fullest potential by providing coaching, mentoring, and appropriate learning opportunities to optimize leading analytical sciences in a virtual setting. Ensure efficient and top-notch development, utilization, and transfer of high-quality and optimized analytical methods and associated specifications for drug substances and/or drug products that meet or exceed the expectations of internal partners and external regulators and that ensure the high and consistent quality and performance of drug substances and/or products. Ensure on-time delivery of high-quality CMC packages for submissions that meet or exceed the expectations of external regulators and lead to first-cycle approvals. Ensure the work conducted by external partners and 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 Embrace inclusion and diversity to create and modern and dynamic working environment across the function. Ensure the team meets agreed performance, throughput and quality targets and that resourcing is aligned to R&D priorities Why you? Basic Qualifications: Bachelors degree in Analytical Chemistry, Biology, Biochemistry, or related technical discipline 12 years' of industry experience Experience managing a group of analytical scientists Scientific knowledge in large molecules (mAbs), methodology and strategies Demonstrated experience with analytical method development, validation and transfer Experience in specification setting Experience of non-regulated, GLP and GMP processes necessary to develop a medicine ready for commercial release and supply to the clinic. Experience reviewing regulatory files (IND, IMPD, BLA, MAA, etc.). Experience effectively handle and appropriately escalate issues based on risk in a timely manner. Preferred Qualifications: PhD, MS in Analytical Chemistry, Biology, Biochemistry, or related technical discipline with 12+ years of experience Experience with coaching, mentoring and developing a diverse group of analytical scientists Experience in building and managing relationships with 3rd parties and leading virtual CMC teams to deliver sound analytical control strategies for drug substances and drug products. Experience with drug substance and/or drug product characterization methodologies Strong understanding of product development disciplines and relationship of analytical testing to drug development Ability to analyze and trend data to drive continuous improvement Experience authoring regulatory files (IND, IMPD, BLA, MAA, etc.) *LI-GSK GSKBiopharm_Development Why GSK? 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: 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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