Director, Drug Substance and Product Analysis

Collegeville, PA
December 17 2020
Other, Other
Are you looking for an opportunity lead the development of analytical methods for a diverse portfolio? If so, this Director, Drug Substance and Product Analysis could be an ideal opportunity to explore.

As Director, Drug Substance and Product Analysis you will lead team in the development of analytical methods for diverse portfolio. You will also be responsible for contributing to the overall operation of the PD Product Development Department including resource planning and budget management.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
  • Provide leadership, guidance and strategic direction to a group of analytical chemists on all aspects of analysis for diverse portfolio
  • Act as the primary Pharmaceutical Development project contact for one or more projects post candidate selection
  • Contribute to the overall operation of the PD Product Development Department including resource planning and budget management
  • Represent team and Product Development at cross functional matrix team meetings and engagements with Senior Leadership
  • Develop and validate robust analytical methods for drug substance and drug product
  • Produce and interpret data to support the release and stability testing of drug substance and drug product
  • Review experiments, stability protocols, and other key documents
  • Author and approve sections of regulatory documents
  • Oversee development and support of flexible cross-modality analytical capability to ensure analytical support of small and large molecule API and drug products
  • Coordinates external collaborations and evaluate potential innovative research areas
  • Perform appropriate Quality Control activities, including analytical testing to support release or rejection of intermediate, bulk and finished products by Quality Assurance
  • Develop and propose stability protocols
  • Develop and propose specifications, sampling instructions, test methods and other Quality Control procedures
  • Monitor contract analytical testing
  • Check the maintenance of premises and equipment.
  • Propose validation protocols and performing appropriate validation of analytical methods
  • Approve analytical test results to support release or rejection of intermediate, bulk and finished products by Quality Assurance
  • Approve stability programs, specifications, sampling instructions, test methods and other Quality Control procedures.

‚Äč Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • BS/MS with at least fifteen (15) years of experience or a Ph.D with at least ten (10) years of experience in a pharmaceutical-related area with appropriate product development experience
  • Experience in development of analytical methods for oral solid dosage forms and IV products
  • Good understanding of the pharmaceutical product development process, from pre-formulation through technology transfer to manufacturing and product registration
  • Experience at the product development/manufacturing interface
  • Demonstrated capability in science and technology-driven pharmaceutical product development
  • Experience in the design and implementation of product development plans.
  • Experience in the provision of regulatory documentation.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Demonstrated leadership skills and ability to manage a team.
  • Ability to work with people at other sites in the GSK network.
  • In depth knowledge of GMP requirements, SOPs and policies relevant to product development.
  • Thorough knowledge of regulatory requirements and drug development process.

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.


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