Product Technology Manager

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Site Name: USA - Pennsylvania - King of Prussia Posted Date: Feb 22 2022 Are you energized by a highly technical manufacturing role that allows you to accelerate efficiency and shape product quality? If so, this Product Technology Manager role could be an ideal opportunity to explore. As a Product Technology Manager, you will manage upstream elements (mammalian cell culture, bioreactors, bioreactor process development) and bioreactor data analysis of the transfer of primary (drug substance) biopharmaceutical production technologies from R&D, third party clients or Contract Manufacturing Organisations to UM Biopharm and from UM Biopharm to other biopharmaceutical manufacturing sites. Support delivery of new biopharmaceutical applications and technologies as well as on delivering improvements to the existing supply chains supported by UM Biopharm and technology transfers between UM Biopharm & R&D. Support efforts to continuously reduce product COGS while improving product quality for products supplied by UM Biopharm. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Support the introduction and possible scale-up of primary(drug substance) processes transferred from R&D or third party clients for specific products new within UM Biopharm. Support establishing resource requirements necessary to implement approved projects. Act as technical UM Biopharm representative on the technology transfer teams and product development project team for specific products. Responsible for managing the relationship between R&D or third party clients and UM Biopharm for specific products and if needed influence decision makers within R&D or third party clients. Propose strategies and priorities in planning technical transfer/process validation activities within area of expertise. Responsible for process trend analysis and assurance that processes remain within control parameters. Responsible for resolving process issues/ problems in a manner and timeframe consistent with production and quality goals for specific products. Ensure technical accuracy of process documentation and related documentation for specific products. Responsible for ensuring that new technologies are properly validated in UM Biopharm and that related regulatory documents to support licensing of specific products are prepared. Evaluate new technologies for GSK and define technology introduction strategies. Define long-term and near-term process improvements within area of expertise. Contribute to evaluations of potential fit of prospective new products into UM Biopharm (e.g. SIAs RFI responses) May need to contribute to technical oversight of manufacturing operations, facility changes or co-ordinating technical activities for specific products at UM Biopharm. Highly organized, effective candidate capable of leading/pursuing multiple projects with some supervision. He/She/They will work in a strong collaborative team environment as well as contribute individually to meet project timelines and objectives. Working knowledge of the analytical methods typically used in the analysis of bioreactor cultures is required Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors degree in either biological or chemical science, Biopharmaceuticals or engineering or equivalent technical discipline. 5 or more years of experience in Biopharmaceutical/pharmaceutical industry or equivalent with significant emphases on technology development and/or process technology transfer. Knowledge of current GMPs, NIH Guidelines and FDA and/or European validation practices for biopharmaceutical processes required Preferred Qualifications: If you have the following characteristics, it would be a plus: Masters degree or PH.D in biology, biochemistry or chemistry Expert knowledge in biopharmaceutical technologies including large scale cell culture/microbial technology, biopseparations technologies, and pharmaceutical manufacturing of proteins. Understanding of analytical technologies related to the above. Strong interpersonal and leadership skills. Strong verbal and written communication skills. Strong Analytical and critical thinking skills. Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines. Able to provide leadership to generate options to resolve problems, prioritise, and decide appropriate courses of actions. Effective at implementing decisions. Committed team player prepared to work in and embrace a team-based culture. Leadership potential. Why GSK? Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, were making the biggest changes weve made to our business in over 20 years. Were on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients so we deliver what matters better and faster; accountable for impact with clear ownership of goals and support to succeed; and where we do the right thing. So, if youre ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please **** (US **** (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 GSKs compliance to all federal and state US Transparency requirements. For more information, please visit GSKs Transparency Reporting For the Record site.,street_address:709 Swedeland Road,
Categories
Healthcare
Management
Manufacturing / Production
Biotechnology / Science
Engineering
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King of Prussia, PA 19406 US
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Posted:
2022-02-23
Expires:
2022-03-25
GSK

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