Are you seeking an opportunity where you can grow your technical expertise on pharmaceutical analysis and development? If so, this Senior Scientist role could be an exciting opportunity to explore.
As a Senior Scientist, you will develop drug product and delivery systems for protein and peptide-based therapeutics. The candidate will execute a wide range of experiments and development studies independently based on a protocol. This role includes identifying and troubleshooting problems in the execution of experimental processes, technical studies, and tasks.
This role will provide YOU the opportunity to contribute to analytical development and to progress YOUR career. Your responsibilities include some of the following …
- Laboratory experimentation, analytical testing, and drug product manufacturing of putative formulations & drug delivery approaches for select protein therapeutic assets, which include contributing to the conception & evaluation of conventional & novel product matrices and administration modalities
- Physicochemical and bioanalytical characterization of Biopharm compounds
- Working with the CMC analytical group to define analytical method target profile for monitoring quality attributes for use in product development, release and stability testing
- Crafting & execution of non-GMP stability studies to generate product and drug product manufacturing process knowledge, and interfacing with the quality organization to craft GMP stability protocols and assess resultant data
- Working closely with internal & external discovery and development support partners, as needed; maintaining accurate, complete laboratory records
- Facile use of electronic data & information gathering, capture, archiving and communications techniques
- Authoring and review of SOPs, technical reports, and regulatory documentation (e.g., IND/IMPD, BLA/MAA/JNDA, etc.).
- Complying with data integrity requirements
- Authoring of technical reports and sections of regulatory documentation
- Bachelor's with 4+ years of laboratory-based experience, or Master's degree with 2+ years of laboratory-based experience, in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
- Knowledge of protein or peptide chemistry, formulation and drug delivery/device development, and drug product manufacturing
If you have the following characteristics, it would be a plus:
- Experience with both conventional and alternative protein formulation and drug delivery/device approaches or experience in protein drug product manufacturing process (fill-finish) area.
Why GSK? Uniting science, talent, and technology to get ahead of disease together
- Experience using bioanalytical and/or biophysical techniques for critically assessing product characterization and product stability evaluation, including e.g., HPLC, capillary electrophoresis, SEC, Spectroscopy (UV/VIS, fluorescence, or CD), & DSC.
- Experience in regulatory documentation authoring (IND/IMPD, BLA/MAA, etc.).
- Ability to collaborate well with others in and across groups in matrix environment
- Ability to communicate effectively
- Organizational skills
- Ability to maintain accurate complete laboratory records
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat is ambitious for patients
- so we deliver what matters better and faster; accountable for impact
- with clear ownership ofgoals and support to succeed; and where we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.
to know more about GSK Biopharm.
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