Biopharmaceutical Drug Substance Product Leader/Owner, NPI
- King of Prussia, PA
Site Name: USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - Pennsylvania - King of Prussia
Posted Date: May 4 2020
Are you looking for an opportunity to optimize the technical performance of GSK products in the supply chain? If so, this is the role for you.
As Biopharmaceutical Drug Substance Product Leader/Owner you will be supporting new product introduction of late stage biopharmaceutical assets into commercial manufacturing settings (internal and external). In addition, this role will be the technical lead to ensure that that process robustness and ongoing commercial manufacturing is effectively managed.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Provide leadership of key improvement initiatives within the department
- With GSK's partner organizations on delivery of aligned objectives
- Provide project support for technology transfer and commercial manufacturing operations
- Drive technical innovation for second generation processes
- Effectively interface with R&D in support of portfolio projects and new product introductions
- Provide early input into design selection and manufacturability considerations
- Work to implement standards of quality by design into robust manufacturing operations
- Maintain knowledge of latest industry trends and become an advocate in the external community
We are looking for professionals with these required skills to achieve our goals:
- BS in Chemical/Biochemical Engineering, Biochemistry, Chemistry or equivalent
- Minimum of 10 years pharmaceutical experience in technical support of commercial manufacturing and/or process development
- Ability to influence, lead and drive change
- Demonstrated record of achievement and broad integrated knowledge of all aspects of biopharmaceutical production processes
- 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
- Ability to manage across multiple projects simultaneously, lead matrix teams, and mentor site based technical staff members
If you have the following characteristics, it would be a plus:
- MS or PhD Chemical/Biochemical Engineering, Biochemistry, Chemistry or equivalent
- Experience in technical support of commercial products, program management, technology transfer to commercial manufacturing sites (internal and to external CMO)
- Experience in process validation and BLA/MAA preparation
- Experience in PAI support for biopharmaceuticals
- Technical support of product lifecycle activities (i.e. CPV, PPR, Change and Deviation Management)
- Knowledge of regulatory requirements for biopharmaceutical production
- Ability to support due diligence activities
- Excellent verbal and written communication skills
Our values and expectationsare 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.
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.
Back to top