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Senior Manager, Downstream Process Development (Biologics)

Waltham, Massachusetts; King of Prussia, Pennsylvania; Collegeville, Pennsylvania
Closing date
Jan 27, 2022

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Other, Manufacturing/QA/QC
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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 The Senior Manager, Downstream Process Development (Biologics) will work within a cross-functional team environment, supporting SED's (Strategic External Development) biologics leadership team in defining and executing against short, intermediate and long-term strategic goals for all biologic's programs. Specifically, under minimal guidance, the incumbent will be responsible for developing and executing CMC goals for downstream process development for multiple biologics programs. She/he will be expected to represent GSK at scientific and regulatory meetings as needed. Senior Manager, Downstream Process Development will manage the collaboration with CDMOs with a focus on the downstream process development and manufacture of biologics drug substance. This position is integral to the advancement of SED's growing portfolio of biopharmaceutical drug candidates and technology programs and will provide technical oversight and strategic input for downstream biologics drug substance development and manufacturing activities. The scope of the role spans from early stage process definition to late stage process characterization study. It extends further to the preparation of CMC content for regulatory submissions, technology transfer and manufacturing support. In accordance with SED's virtual (100% outsourcing) model for drug development, the incumbent will oversee the planning and execution of outsourced CMC activities and work proactively with service providers to define project scope and ensure successful delivery regarding technical quality, timelines and budget. She/he will contribute to the identification and selection of CROs and CDMOs and building/maintaining strong working relationships with their respective technical staff and management. Key Responsibilities o Provide technical leadership, management and oversight for: o Development of robust purification processes utilizing multiple chromatography modes, filtration (normal and tangential flow) and clarification technologies. o Optimization and characterization of downstream manufacturing processes based upon quality by design (QbD) principles including linkage and worst-case studies. o Tech transfer, scale-up and manufacture of biologics drug substance to support nonclinical studies and clinical evaluation. o Interface with upstream, analytical, formulation, Regulatory, QA/QC groups to ensure alignment with overall program objectives. o Process Validation activities of biologics drug substance to support product commercialization. o Oversee phase appropriate viral clearance studies to enable regulatory submissions. o Prepare CMC documentation for regulatory and/or patent filings and prepare/reconcile responses for responsible topics. o Establish and maintain an understanding of current trends in purification technologies o Set clearly defined goals/objectives to ensure delivery of high-quality results. o Provide clear communication to CMC teams and functional line management regarding progress against technical objectives/milestones. o Ensure well-organized, clear and complete documentations of all activities across areas of responsibility. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Ph.D. in (bio)chemical engineering, biochemistry or related field with 5+ years or MS with 7+ years relevant experience. Experience in downstream process development from early process definition to late stage process characterization study. Experience managing projects and work with cross-functional teams comprised of internal and/or external contacts. Experience working with CDMOs. Experience with cGMP regulations. We are looking for professionals with these required skills to achieve our goals: Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience in preparing CMC documentation for regulatory submissions. Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration in a multi-disciplinary business and science team environment is essential. Personal attributes: self-starter; attentive to details; accountable; committed while maintaining balance and perspective. Others will describe you as honest, trustworthy, and respectful of others; a person of high integrity, a good listener, a straightforward communicator, and a team builder. Ability to work in a fast-paced and dynamic corporate environment with changing priorities, and flexibility to support multiple development programs simultaneously. Ability to solve the problems using innovative thinking and good decision making. Ability to lead innovation, change and drive for results. Experience in managing technical teams and external partners Strong collaboration and communication skills; ability to build and maintain strong ties with internal and external stakeholders. Ability to travel, not to exceed 20% (domestic and international). *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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. 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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