Senior Formulation Scientist

2 weeks ago

Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

Company:
GlaxoSmithKline

Position Overview:
Are you an experienced scientist specializing in sterile product formulation and injectables, ready to spearhead the creation of transformative drug products? This opportunity allows you to merge scientific expertise, talent, and technology to combat diseases effectively.

In the role of Senior Formulation Scientist, you will be an integral part of the GSK sterile Drug Product Development team, focusing on the advancement of late-stage drug product formulations, manufacturing processes, and delivery systems for protein-based therapeutics and new chemical entities (NCEs).

Key Responsibilities:
As a valued member of our team, your contributions will include:
1. Collaborating with a team dedicated to facilitating the transition of new assets from candidate selection to market readiness.
2. Designing, planning, and executing studies aimed at optimizing formulations, characterizing processes, and evaluating stability and compatibility in real-world applications.
3. Analyzing complex data and interpreting results accurately to inform decision-making.
4. Conducting physicochemical and bioanalytical assessments of both native and modified biopharmaceuticals and NCEs.
5. Authoring and executing non-GMP stability protocols to assess the quality and longevity of product formulations.
6. Maintaining meticulous laboratory records to ensure compliance and accuracy.
7. Developing and scaling up sterile product manufacturing processes for transfer to production facilities.
8. Authoring and reviewing technical documentation and reports to support projects at various development stages.
9. Collaborating closely with internal and external partners to ensure project success.
10. Utilizing electronic data management and communication tools effectively.
11. Assisting in the preparation and review of standard operating procedures (SOPs) and regulatory submissions as necessary.
12. Engaging with project teams to conduct thorough root cause analyses and investigations.

Qualifications:
We seek professionals with the following qualifications:

- A PhD in Pharmaceutics, Biology, Biochemistry, Biotechnology, Chemistry, or Chemical Engineering, with a focus on protein formulation and drug delivery; or a Master’s degree with a minimum of 5 years of relevant experience; or a Bachelor’s degree with over 10 years of experience.

- A PhD with at least 2 years of industry experience is preferred.

- A minimum of one year of experience in protein and peptide chemistry, as well as formulation and biophysical characterization of biopharmaceuticals.

- Proven experience in authoring technical reports and regulatory documentation (IND/IMPD, BLA/MAA, etc.).


Preferred Skills:
If you possess the following skills, it would be advantageous:

- Experience with biophysical techniques for product characterization and stability evaluation, including spectroscopy, differential scanning calorimetry, and particle size evaluation.

- Familiarity with both traditional and innovative biopharmaceutical protein formulation and drug product development, including the application of design of experiments (DOE) methodologies.

- Experience in drug product manufacturing processes and technology transfer to commercial production.

- Strong communication skills, both oral and written, and the ability to work independently as well as collaboratively in team settings.

- A creative and motivated approach to problem-solving, with a focus on maintaining accurate laboratory records and effective data management.


Why Join Us?
At GlaxoSmithKline, we are committed to uniting science, technology, and talent to advance healthcare. We focus on innovative solutions that address critical health challenges and aim to create an inclusive environment where all employees can thrive. If you share our vision and passion for improving global health, we invite you to explore this opportunity with us.

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