Biopharmaceutical Product Owner, NPI

Company: GlaxoSmithKline
Location: Rockville
Posted on: September 11, 2020

Job Description:

Are you seeking an opportunity to-- leverage your expertise to work with and influence CMOs; apply your scientificknowledge to enable successful tech transfer, maintain the product throughout the life cycle and meet the demands of the supply chain to provide quality product to the patient? --If yes, our Biopharmaceutical Product Owner, NPI opportunity may be the right position for you to explore.Job Overview:In this role, you will join a team of scientists and engineers supporting new product introduction (NPI) of late stage biopharmaceutical assets into commercial manufacturing settings (internal and/or external).-- For products where the DS is manufactured at CMOs, this role will be the technical lead to ensure that process robustness and ongoing commercial manufacturing is effectively managed.Additional responsibilities may include leadership of key improvement initiatives within the department and working with our partner organizations on delivery of aligned objectives.-- In addition, as a technical expert will provide leadership for technology transfer and commercial manufacturing operations, driving technical innovation for second generation processes, and effectively interfacing with R&D in support of portfolio projects and new product introductions, providing early input into design selection and manufacturability considerations.-- This position will focus on drug substance support, with demonstrated experience in upstream and downstream processes.--In partnership with R&D and Pharma Supply Chain (PSC), the incumbent will work to implement standards of quality by design (QbD) into robust manufacturing operations, maintaining knowledge of latest industry trends and becoming an advocate in the external community.-- The position requires the ability to manage across multiple projects simultaneously, lead matrix teams, and mentor site based technical staff membersNote:-- Future expectations for travel will vary based on portfolio needs, estimating - 10-20%.-- This position will begin as 100% remote.-- As circumstances evolve this role will eventually involve some on site work.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:BS/MS/PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry, or or other similar technical or life science subject area.Minimum of 7 years --biopharmaceutical / pharmaceutical industry experience in technical support of clinical/commercial manufacturing and/or process development.--Experience in program management and technology transfer to manufacturing sites.Preferred Qualifications:If you have the following characteristics, it would be a plus:Experience in technical support of --commercial manufacturing sites (internal and to external CMO), leadship in process validation and BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e. CPV, PPR, Change and Deviation Management), and knowledge management.Experience in unit operations including mammalian cell culture, filtration, chromatography, and UFDF.Knowledge of regulatory requirements for biopharmaceutical production, including principles of quality by design.-- Ability to support due diligence activities.Demonstrated record of achievement and broad integrated knowledge of all aspects of biopharmaceutical production processes, and ability to work effectively in cross-functional teams to deliver results to agreed timelines.Broad and integrated knowledge and experience that can impact project and workgroup direction. Working knowledge of regulatory requirements in the industry and drug development.Must have excellent verbal and written communication skills, and ability to influence, lead and drive change.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 riskManaging 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-GSKIf 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/ AgenciesGSK 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.Full time

Keywords: GlaxoSmithKline, Rockville , Biopharmaceutical Product Owner, NPI, Other , Rockville, Maryland