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Scientific Leader - Downstream Process Development at GlaxoSmithKline

Posted in Science 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: King of Prussia, Pennsylvania

Job Description:

Are you energized by a scientific leadership role that allows you to enhance and improve processes across biopharmaceutical product development?  If so, this Scientific Leader role could be an ideal opportunity to explore.

As a Scientific Leader, you will be responsible for leading internal and external development of recovery and purification processes for both early and late stage biopharmaceutical assets.

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

  • Agility to adapt to changes in the balance of internal and external portfolio. Must have significant expertise in protein purification and process development at bench-scale with experience in process scale-up, and a corresponding demonstrated record of achievement and broad integrated knowledge of the field.

  • Supporting internal/external manufacturing processes as a subject matter expert, including the authoring and review of externalized work packages and scope of work documentation.

  • National and international travel may be required to support technology transfer and manufacturing activities.

  • Involvement in the authorship and review of INDs/IMPDs and BLAs/MAAs for biopharmaceuticals; process characterization, validation and technology transfer for commercial manufacture, as well as process transfers to support manufacture for early- and late-stage clinical trials. 

  • As a technical leader, using extensive technical knowledge and ability to turn concepts into manufacturing methods; interpreting complex data and information and making decisions and proposals that impact quality and cost. 

  • Managing across multiple projects simultaneously, leading matrix teams, supervising, mentoring, and training staff members (group of 3-8 scientists). 

Why you?

Basic Qualifications:

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

  • PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry, or Biology, or other relevant discipline with 7 or more years industrial experience in therapeutic protein purification process development, or BS/MS graduate with equivalent experience. 

  • Expertise in therapeutic protein purification, process development, scale-up, and technology transfer.

  • Demonstrated record of achievement and broad integrated knowledge of all aspects of the work.

  • Thorough knowledge of drug development and of regulatory requirements in the industry, including familiarity with cGMPs. 

  • Experience contributing to CMC matrix project teams

Preferred Qualifications:

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

  • Experience with both early and late phase development of purification processes, process scale-up, technology transfer (internal and to external CMO), process validation and BLA/MAA preparation for biopharmaceuticals.

  • Previous experience demonstrating strong business acumen in supporting external process development and manufacturing activities is strongly preferred.

  • Requires excellent oral and written communication skills to effectively deliver new medicines via internal and external CMC efforts. 

  • Broad and integrated knowledge and experience that can impact project and work-group direction.

  • Demonstrated record of innovation and technology development.  Knowledge of regulatory requirements for biopharmaceutical production, including principles of quality by design and virus clearance validation.

  • Experience with purification of protein products from both mammalian and microbial cell culture. 

  • Experience executing performance management cycle activities. 

  • Experience leading CMC matrix project teams. 

  • Involvement in external scientific and industrial community as demonstrated by a record of presentations, publications and participation in conferences.

  • Demonstrated ability to supervise and mentor others.  Experience recruiting and training staff.

Why GSK?

Our values and expectationare 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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