Biopharmaceuticals Manager -LCMS Protein Characterization - GlaxoSmithKline plc (Nazareth)

Employment Type

: Full-Time

Industry

: Non-Executive Management



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Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals? If so, this Biopharmaceuticals Manager-LCMS Protein Characterization role could be an exciting opportunity to explore.

The mass spectrometry group is well equipped with modern instrumentation including a Synapt G2 with IM, Orbitrap Fusion Tribrid, LTQ-XL Orbitraps, Q-TOF Premier, 2D-NanoUPLC, Nano-UPLC, UPLC and many other supporting instrumentation and associated data analysis software packages.

Key Responsibilities:

This position will be in the Structure and Function Characterization Department of the CMC Analytical Organization. This role will provide you the opportunity to lead key activities to progress your career. Some of the responsibilities include following:

  • Supervising a team of more than 4-5 PhD/MS/BS level scientists to support the development of GSK biopharmaceutical assets from candidate selection through post-approval support.
  • Lead the teams efforts on product characterization, comparability studies, process development support, manufacturing support and contribution to regulatory submissions.
  • Develop novel characterization strategies, including but not limited to LC/MS/MS, H/DX-MS and IM-MS, biophysical and associated technologies for the support of biopharmaceutical development.
  • develop long-term strategies in characterization support for biopharmaceutical development
  • Lead and/or participate on project CMC teams and/or analytical subteams and contribute to authoring the CMC sections of regulatory submissions.
  • Why you?

    Basic Qualifications:

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

  • A Ph.D. degree in analytical chemistry, biochemistry, pharmaceutical sciences or related fields, with 8 or more years of relevant experience in biopharma. .
  • Extensive knowledge and experience in protein characterization using modern mass spectrometry, with hands-on experience with LC/MS instrument operation, nano-LC fluidics and LC/MS/MS, methods data processing software and workflows
  • In-depth knowledge and hands-on experience in various separation techniques such as CE and HPLC/UPLC
  • Several years of experience managing a team of individual contributors.
  • Preferred Qualifications:

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

  • Sound understanding of biopharm analytical strategies and product life cycle and QbD principles
  • Experience in analysis of protein therapeutics, along with a sound understanding of protein structure and function relationships.
  • Knowledge and/or experience with biophysical techniques such as CD, FTIR, Fluorescence, DSC, DLS, AUC and flow imaging techniques for protein higher order structure analysis and particle characterization would be highly desirable.
  • Experience and knowledge of product characterization requirements and practices during different stages of biopharm development.
  • Experience with developing risk based and phase appropriate product characterization and comparability strategies
  • Knowledge and experience in authoring relevant regulatory documents and interaction with global regulatory agencies
  • Experience in leading or participating in multidisciplinary project teams and sub-teams, and excellent communication and interpersonal skills
  • Why GSK?

    Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.

    We want to help people do more, feel better, live longer

    We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.

    Across the US, we employ more than 15,000 people who strive to help others do more, feel better and live longer. This work starts one person, one community, and one story at a time. Find out more about how we are doing more across the US

    As a science-led, global healthcare business with clear values, we offer countless opportunities for people at various stages of their careers. On-the-job learning and rewarding individual contributions are extremely important to us. We believe in creating an inclusive and safe working environment and supporting our employees to help their communities.

    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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