• GlaxoSmithKline PLC
  • Drexel Hill , PA
  • Miscellaneous
  • Full-Time
  • 759 Cornell Ave

Are you looking for an opportunity to develop future scientific leaders while undertaking cutting edge scientific research to drive future insights? If so, this is the role for you.

As the Head of BioPharm Product & Device Development you will be responsible for creating a vibrant environment of collaboration through the application of industrial expertise to enhance biological understanding through solving business challenges. You will Identify quality attributes for BioPharm products which are important to ensure patient needs are met encompassing formulation & dosage form, delivery strategy & administration, secondary manufacturing processes, and parenteral delivery devices.

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

  • Highly influential in setting long term strategies for BioPharm assets/ technologies on an 18 to 36-month planning horizon. Defines and executes well-coordinated strategies based on personal/ others experience.
  • Define clear design intents for BioPharm formulation & dosage forms, delivery strategies & administration, secondary manufacturing processes, and parenteral delivery devices in partnership with Project Teams, Therapeutic areas, and commercial development partners.
  • Ensure selected design intents are appropriately evaluated across all relevant patient groups during clinical and commercial phases.
  • Ensure BioPharm formulation & dosage forms, delivery strategies & administration, secondary manufacturing processes, and parenteral delivery devices are developed in line with Quality by Design principles and that all elements are suitably risk assessed, tested, and transferred to internal/ external partners throughout the entire development lifecycle.
  • Collaboratively resolves technical issues experienced by partners in BPDS, MST, PSC, or external supply chains.
  • Conduct rigorous line and cross-functional peer reviews of BioPharm formulation & dosage forms, delivery strategies & administration, secondary manufacturing processes, and parenteral delivery devices to assure development science represents best practice and is suitable to appropriately underpin governance reviews.
  • Support relevant governance reviews including CMC-ST, NPSB, TIB, PIB, etc, to ensure all relevant aspects of BioPharm assets are reviewed and endorsed for progression through appropriate development stages.
  • Prepare regulatory dossier content which documents the design, development and commercialization of BioPharm formulation & dosage forms, delivery strategies & administration, secondary manufacturing processes, and parenteral delivery devices ensuring that the scientific content meets or exceeds standards required for regulatory approval/ licensing.
  • Review asset / technology in-licensing efforts suitably defining risks, opportunities, and resource requirements to diligence teams.
  • Define, collect, and appropriately react to metrics and relevant customer feedback to ensure department is achieving objectives and delivering customer satisfaction with attention to quality, efficiency, and collaboration.
  • Strong ability to identify and develop talent via internal and external networks.
  • Why you?

    Basic Qualifications:

    We are looking for professionals with these required skills to achieve our goals:

  • PhD or equivalent in Biotechnology, Pharmacy Sciences, and/or Engineering
  • 10+ years of experience in Pre-Clinical, Clinical, and Commercial Stage Drug Product Development encompassing competence across formulation & dosage form, delivery strategy & administration, secondary manufacturing processes, and parenteral delivery devices for BioPharmaceutical Products
  • Experience in the delivery of drug discovery through program leadership
  • Preferred Qualifications:

    If you have the following characteristics, it would be a plus:

  • Elevated level of scientific achievement resulting in a high degree of scientific credibility
  • Highly effective leadership skills with multidisciplinary teams
  • Knowledge of establishing and maintaining excellent working relationships with collaborators
  • Ability to train and develop the next generation of scientists
  • Flexible thinking and ability to thrive in different environments
  • A proven ability to persuade and influence
  • Excellent communication and interpersonal skills
  • 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.

    *LI-GSK

    *GSKBiopharm_Development

    If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-###-#### (US Toll Free) or +1 801 ### #### (outside US).

    GSK is an Equal Opportunity/Affirmative Action Employer. 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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    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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