GSK

Director, Upstream Process Development

Employer
GSK
Location
King of Prussia, PA
Salary
Competitive
Posted
September 30 2021
Ref
289692
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 As the Director, Upstream Process Development, you will be a strong and visionary leader for a team of approximately 10-12 exceptionally talented and experienced scientists and engineers. This team is responsible for development, scale-up, and technology transfer of late stage cell culture processes for the clinical and commercial manufacture of biopharmaceuticals using mammalian expression systems. You and your team will be responsible for authoring and reviewing technical reports, protocols, technology transfer documents, and CMC sections of regulatory filings; you will also represent GSK as a thought leader at external scientific meetings and cross-industry consortia. The Director, Upstream Process Development will represent and be the voice of the department on project teams and is also expected to interact on a routine basis with colleagues in downstream process development, analytical, clinical/commercial manufacturing, quality, and regulatory groups. In addition, you and their team will drive technology development efforts within the department, including development of proprietary cell culture media, process intensification, industrialization of new cell culture operating modalities (e.g., perfusion), and integration of data science and modeling solutions into process development workflows. The Director, Upstream Process Development will engage with senior leadership to participate in strategic planning for the direction of the department and the wider Biopharm CMC organization. You will also be responsible for actively managing performance and developing talent within their team. You will comply with all the requirements of GSK policies and be a role model of values, safety, and integrity Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Ph.D. in Chemical/Biochemical Engineering or related Biological Sciences highly preferred; BS/MS required 7 years of leadership experience with experience building high-performing teams 10 years of experience in the Pharmaceutical/Biotech industry Experience in developing cell culture processes for the production of biopharmaceuticals Experience cGMP requirements of manufacturing processes for biopharmaceuticals Experience with data integrity principles Experience with process characterization, scale up, and technology transfer to manufacturing sites Experience authoring CMC sections of regulatory filings, including BLA/MAA Experience with QbD approaches, including control strategy development Supervisory experience leading technical and matrix teams Preferred Qualifications: If you have the following characteristics, it would be a plus: Excellent written and oral communication skills Detailed knowledge of process validation requirements Experienced with having worked on a marketed product Working knowledge of PAT tools such as Raman spectroscopy and process intensification technologies such as ATF/TFF Experience developing and industrializing new technologies for cell culture process development Experience integrating advanced data analysis / modeling tools (e.g., DoE, multivariate analysis, AI/ML) into process development workflows A thorough knowledge of the workings of large-scale bioreactors, including mass transfer, mixing, etc. Experience collaborating with contract development/manufacturing organizations 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. *LI-GSK GSKBiopharm_Development 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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