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Lead Molecule Steward - Large Molecule

Employer
GSK
Location
King of Prussia, Pennsylvania; Rockville, Maryland
Salary
Competitive
Closing date
Oct 5, 2022

View more

Discipline
Other, Other
Organization Type
All Industry, Pharma
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The Lead Molecule Steward has management responsibility for a team of Molecule Stewards or leadership of enterprise projects. The lead molecule steward is also expected act as a molecule steward, setting the standard for the role and ensuring other molecule stewards meet the expectations and requirements for the role

You will act as the single point of end-to-end technical accountability for a given product, from bulk API manufacturing, formulation, filling, assembling, packing and related support activities, providing strategic technical leadership to ensure successful new product introduction, quality robustness and productivity improvements across the lifecycle. 

This role is aligned to a new asset at Commit to Commercial Development with responsibility for representing MSAT in the development of the Product Control Strategy. When the product transfers to GSC accountability, the Molecule Steward co-ordinates Drug Substance, Drug Product, Analytical Strategy and if appropriate Device Leads to maintain the Product Control Strategy and ensure the product is maintained in the desired state of control through product lifecycle.

You will be the recognized expert in the given product or dose form and in addition to strategic technical leadership, you will be expected to provide deep technical expertise where required to ensure highest levels of quality and robustness.

This role will provide/gives YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
  • Leading a team of Molecule Stewards, setting the standard for the role and ensuring other molecule stewards in the team meet the expectations and requirements for the role.
  • Leading on key enterprise projects from an MSAT perspective, providing strategic leadership and expertise to projects without direct product accountabilities.
  • Representing MSAT, providing a single point accountable decision maker MDIT or MSCT, ensuring that a product control strategy is defined and maintained to drive a robust product that meets manufacturability criteria.
  • Defining the End-to-End Product Performance Qualification and Ongoing Continuous Verification Strategy for the product, including trending and sampling plans and ensuring alignment and consistency across supply nodes.
  • Maintaining accountability for the product, from transfer from R&D throughout its lifecycle, ensuring improvement plans (including 2nd generation processes) are developed and delivered impacting the manufacturing process, analytical process, pack, device, and associated specifications to deliver value.
  • Staying current and maintaining solid knowledge and understanding of complex scientific subject matter and evolving regulatory policies and guidelines and industry best practices.
  • Staying accountable from an MSAT perspective for defining technology strategy & specific solutions as required to support the overall product or dose form lifecycle.
  • Leading PTRT's, ensuring risks are identified and mitigated and technical issues are resolved in a timely manner.
  • Coordinating the review of regulatory submissions and responses to technical questions across MSAT, ensuring review by appropriate SME's and sites.
  • Providing leadership and subject matter expertise where required for investigations and/or critical deviations, troubleshooting, and major change programs.
  • Ensuring that product history and knowledge from development through lifecycle is maintained and aligns with knowledge management standards for the product or dose form within the GSC network.
  • Developing and managing strong collaborations with technical staff across the Supply Chain sites, MSAT & R&D, with effective and clear communication on highly technical topics.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • BSc in a scientific discipline
  • Ph.D. plus 10+ years' experience, MSc plus 12+ years' experience, or BSc plus 15+ years' experience in a scientific discipline
  • Experience leading the technical aspects of Product Lifecycle Management in the pharmaceutical industry
  • Experienced in technology transfer, with an understanding of the product development process
  • Comprehensive knowledge of external regulatory requirements (MHRA, FDA), and internal/external quality and safety requirements. Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
  • Experience working with / knowledge of Quality by Design (QbD) and risk management approaches
  • Project management and prioritization skills gained within a complex matrix.
  • Track record of improving products, processes and troubleshooting, execution of technical activities including trials and validation activities
  • Experience in problem solving with the ability to think and work creatively.
  • Experience leading technical aspects of investigations


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • PhD/MSc in scientific discipline
  • Strong technical acumen and communication skills with the ability to articulate complex, technical details to stakeholders and enable cross functional collaboration across sites, supply chain, R&D and suppliers.
  • Experience leading and operating in an environment with high degree of change and uncertainty.


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, governance and control, managing ambiguity and paradox.
  • Managing individual performance.
  • Creating a performance culture and driving results, prioritisation, execution, delivering performance.
  • Setting strategic direction and leading on-going organisational transformation.
  • Building a resilient organisation.
  • Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
  • Managing P&L and capital allocation.



GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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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