Scientist

Job Description

GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. 
 
Drug Product Development (part of the wider Medicine Development and Supply organization) 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 both small molecule and biopharm drug product/ device development and packaging.  We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience.

 
Within Drug Product Development (DPD), the DPD-Steriles department focuses on developing world class patient-centric biopharmaceutical and small-molecule drug products through innovation, technology and strategic partnering. The successful candidate for this position will focus on biopharmaceutical development, more specifically on the development of drug product and delivery systems for protein and peptide-based therapeutics.  This role may include protein formulation, stability and shelf-life assessment, and drug product process development and transfer activities.

Role responsibilities will be focused on laboratory experimentation, analytical testing, and contributing to development of protein formulations & drug delivery approaches (including in-use evaluation to ensure product quality during product administration). Development studies may require application of physicochemical and bioanalytical characterization of Biopharm compounds; 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. The position may also require authoring and review of SOPs, technical reports, and regulatory documentation (e.g., IND/IMPD, BLA/MAA/JNDA, etc.).

Key responsibilities include:

• Designs and executes protocols related to area of expertise
• Executes a wide range of experiments and development studies independently based on a protocol
• Identifies and troubleshoots problems in the execution of experimental processes, technical studies, and tasks.
• Understands the rationale and hypotheses for experimental designs and/or has extensive theoretical understanding of a particular area of science.
• Develops understanding of regulatory requirements
• Complies with data integrity requirements
• Authors technical reports and sections of regulatory documentation

Basic Qualifications:

• Bachelor’s or Master’s degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
• For BS degree, ≥4 years of laboratory-based experience; For MS degree ≥2 years of laboratory-based experience

Preferred Qualifications:

• Knowledge and/ or competencies in protein or peptide chemistry, formulation and drug delivery/device development, and drug product manufacturing
• Experience with both conventional and alternative protein formulation and drug delivery/device approaches or experience in protein drug product manufacturing process (fill-finish) area.
• Experience using bioanalytical and/or biophysical techniques for critically assessing product characterization and product stability evaluation (e.g., HPLC, capillary electrophoresis, Spectroscopy (UV/VIS, fluorescence), SLS, DLS & DSC).
• Technical report writing and regulatory documentation authoring experience (IND/IMPD, BLA/MAA, etc.).
• Creative and motivated self-starter
• Strong organizational skills
• Maintains accurate, complete laboratory records
• Ability to work effectively in team and matrix environment
• Excellent verbal communication and technical writing skills
• Ability to maintain accurate complete laboratory records

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes 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 genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.​

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With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.​

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Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals 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 this exciting moment in our journey. Join our challenge to get Ahead Together.​

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or 1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. 

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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