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Biopharmaceutical Process Development/Data Enablement Lead Downstream Process Development

Employer
GSK
Location
King of Prussia, PA
Salary
Competitive
Closing date
Dec 7, 2020

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Discipline
Life Sciences, Biochemistry, Other, Manufacturing/QA/QC
Organization Type
Pharma
Biopharmaceutical Process Development is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive products and manufacturing processes spanning the full life-cycle of asset development from Discovery through commercialization. These activities are delivered through state-of-the art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC activities encompassing cell line development, cell culture/ microbial fermentation, purification development, and drug product/ device development. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience.

Within Biopharmaceutical Process Development (BPD), the Downstream Development (DPD) department is responsible for the development of harvest and purification processes for the manufacture of GSK's Biopharm assets. The Department is also responsible for the scale-up and technology transfer of the processes to manufacturing facilities all over the world. Our aim is to integrate innovative processes and platforms, automation and advanced data analytics into the downstream process development workflow. An opportunity has arisen for a data enablement specialist with the ability to assist in the development of information systems to support the gathering, curation and visualization of scientific data.

In this role, you will be a member of a highly skilled team of scientists, engineers and IT specialists responsible for development and maintenance of information systems, such as electronic lab notebooks (ELN), reference data management, and visualization tools. Although most of the work will be supporting DPD, these data enablement efforts span the entire BPD organization, as well as the broader R&D organization. The role also involves important aspects of verbal and written communication and requires good organisation skills. You will be working in a matrix team and therefore the role will suit someone with good interpersonal skills, ability to solve complex problems, is self-motivated and has an open mindset.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
  • Participation in the development of software and hardware solutions, to serve as an advocate for scientists in BPD that will be using these systems.
  • Construction and maintenance of dashboards to provide insight into business and scientific concerns.
  • To facilitate implementation and adoption of solutions by serving as a lead user in one or more information systems.
  • To facilitate usage of information systems for scientists in the labs by overseeing the deployment of fit for purpose hardware (i.e. automation, tablets, barcode scanners, touch-screen dashboards).


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • BS/MS in Computer Science, Managed Information Systems (or business degree equivalence), Bioprocess/Biochemical/Chemical Engineering, Biology, Chemistry, Computer Science, Applied Mathematics, Physics, or Statistical Sciences with 3+ years of industry experience (preferably in a CMC organization).
  • Experience and understanding in information technologies and systems and their applications in CMC activities (e.g. Laboratory Information Management Systems, Electronic Lab Notebooks, Chromatography Data Systems, Distributed Control Systems).
  • Expertise in assembling, analysing, and visualizing complex data sets (e.g. Spotfire, Power BI).


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Ability to effectively communicate and influence senior stakeholders, scientists, and IT colleagues.
  • Highly motivated self-starter, with excellent verbal and written communication skills.
  • Proven track record in implementation of new ways of working.
  • General understanding of the overall biopharmaceutical development process.


Experience in one or more of the following:
  • Agile software development.
  • Served as an administrator and/or subject-matter expert for the support and/or development of scientific information systems.
  • Experience serving as a change manager or change agent for a project.
  • Programming skills in one or more languages (e.g. Python, SQL, C#, VB.NET).
  • Developed an application used across multiple business units.
  • Data science and modelling expertise.
  • Lab experience in biopharmaceutical or pharmaceutical development.
  • Business analysis for gathering of software requirements.
  • PMP certification.


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:

  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

*LI-GSK

GSKBiopharm_Development

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