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Senior Manager/Associate Director - Upstream Process Development

Waltham, Massachusetts; King of Prussia, Pennsylvania
Closing date
Jan 26, 2022

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Other, Manufacturing/QA/QC
Job Type
Manager, President/CEO/Director/VP
Organization Type
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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/Associate Director, Upstream Process Development (Biologics) will work within a cross-functional team environment, supporting GSK's biologics leadership team in defining and executing against short-, intermediate- and long-term strategic goals for all biologics programs. Specifically, under minimal guidance, the incumbent will be responsible for developing and executing CMC goals for upstream process development for multiple biologics programs. She/he will be expected to represent GSK at scientific and regulatory meetings as needed. Ability to travel, not to exceed 20% (domestic and international). Specific Accountabilities: Provide technical leadership, management and oversight for: Development of stable mammalian cell lines and establishment/release of cell banks for GMP manufacturing. Development, optimization and characterization of robust upstream manufacturing processes based upon quality by design (QbD) principles. Tech transfer, scale-up and manufacture of biologics drug substance to support nonclinical studies and clinical evaluation. Prepare CMC documentation for regulatory and/or patent filings. Establish and maintain an understanding of current trends and emerging cell line and upstream process development technologies Set clearly defined goals/objectives to ensure delivery of high-quality results. Provide clear communication to CMC teams and functional line management regarding progress against technical objectives/milestones. 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 closely related field with 5+ years or MS with 8+ years relevant experience. Experience in upstream process development from early phase cell culture process development to late stage cell culture process characterization study. Experience building relationships and working with CDMOs. Experience in preparing CMC documentation for regulatory submissions. Experience in managing technical teams and external partners Preferred Qualifications: If you have the following characteristics, it would be a plus: Strong collaboration and communication skills; ability to build and maintain strong ties with internal and external stakeholders. Ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts. Familiar with cGMP regulations. 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. 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. 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: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness *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. 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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