Director Scale Up and Stewardship

Richmond, VA, Virginia
Feb 05, 2021
Feb 27, 2021
Jobseeker Type
Organization Type
The Director of Scale up & Stewardship sets direction for and leads the Scale up and Stewardship team within Global Formulation Excellence, Scale Up & Stewardship.

The role ensures projects meet agreed timelines and budgets. It also provides resource prioritization as per agreed strategy and provides guidance as follow:

To the Stewardship team on formulation strategy and works with cross functional team from stability, micro, analytical, supply chain technical towards development of a robust formulation. They also collaborate with regulatory and CMC to ensure alignment with individual market registrations and with Commercial & SC Value Engineering when applicable.

To the Scale up team of Process Engineers that develops and sets the control strategy for all NPIs and leads the technical transfer of the product from the pilot plant to the factory while working in conjunction with SC. This team is responsible for technical transfer of all NPIs be it for the categories or for relevant stewardship projects.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Provides leadership to the team in terms of formulation strategy while keeping all other areas such as analytical, micro, stability engaged in the changes to ensure robustness.
  • Provides leadership to the team to deliver robust, efficient, and valuable manufacturing processes for NPI and Stewardship projects.
  • Provides leadership to the team and contributes to the Development report and Technical Risk assessment and sets the Control Strategy for NPI's and relevant Stewardship projects.
  • Manages overall project priorities and ensures team activities are in accordance with GSK standards and regulations, taking into account scientific, budgetary, timing objectives and direction from supervisor.
  • Supports the team in developing expert processing equipment understanding/characterization - at different scales to assist in development of scale-up models.
  • Engages with R&D teams to understand technologies employed in Category and Regional products and associated challenges.
  • Ensures seamless collaboration with other R&D or GSK stakeholders (e.g. GMS and QA) in the Scale Up/NPI and Stewardship projects and ensure alignment of activities.
  • Leads the resource planning and provides visibility to the Category/Region stewardship & scale up lead as well as the program and strategy lead.
  • Proactively reports and communicates with key stakeholders utilizing proper tracking mechanisms that manage timelines and budget requirements.
  • Ensures optimal utilization of resources.
  • Provides technical leadership and sets direction for their team.
  • Ensures principals of Quality by Design (QbD), Operational Excellence (OE) and Value Engineering/Design to Value are appropriately utilized in the product development process.
  • Develops strong, collaborative relationships with other departments/groups and fosters an environment of knowledge sharing.
  • Coaches, mentor and lead the Scale up and Stewardship team members.
  • Participates in the identification, recruitment and retention of talent.
  • Creates an environment that encourages both technical and leadership development and rewards appropriately.
  • Sets high standards for individuals in key areas of technical activities and effectiveness.
  • Provides opportunities for training, development and coaching/guidance when needed.
  • Establishes an environment that supports and nurtures scientific understanding and innovation among the team.
  • Ensures that team is highly motivated. Encourages presentation of work and participation in events for professional exposure and to promote presence and pride in CHR&D. Timely recognition of accomplishments and excellence in job performance, development opportunities, etc.
  • Directsthe development of all activities in accordance with GSK policies, laws, qualitystandards, SOPs, etc.
  • Ensures that internal staff are working and maintaining labs in a safe manner and that housekeeping is maintained.
  • Ensures that documents, formulations and analytical methods produced in accordance with appropriate levels of GMP's, SOPs and safety requirements; ensures appropriateness of specifications for drug substances/products.
  • Provides relevant input to budgeting process.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • BA Degree or PHD in Chemical, Pharmaceuticalor related science.
  • 20 years' experience End toproductdevelopment experience.
  • Experience inConsumer Health/ FMCG product development process.
  • Experience in leading cross functional technical teams.
  • Experience with CGMP requirements.
  • Experience in OTC / consumer product and process development.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • MS Degree or PHD in Chemical, Pharmaceuticalor related science.
  • History of demonstrated expertise in the development of conventionalOTCand/or Consumer products.
  • Excellent oral and written communication skills at all levels within the organization.
  • Track record of coaching, mentoring, leading and developing people to build strong collaborative teams working in a high-performance environment in a culture that values scientific rigor and empowerment.
  • External communication and/or network with regulators, external collaborators and/or scientific experts.
  • Excellent relationship building, influencing and organizational and project management skills.
  • Excellent understanding of Drug and Food GMPs as relevant to GSK Consumer Healthcare as well as familiar with FDA, European and global regularity requirements, such as ICH.
  • Excellent understanding of scientific and commercial aspects of Consumer HealthcareorConsumer Goodsindustry.
  • Experienced in negotiating and agreeing timelines and milestones with sponsors/ business partners and continually monitoring progress to ensure timely delivery.
  • Deep understanding of Quality of Design (QbD), Operational Excellence (OE),Value Engineering/ Design to Value principles,Scaleup &TechnologyTransferand how they apply in a ConsumerdrivenR&D environment.

Why GSK?

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.

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