Location: hybrid onsite Upper Providence, PA - 3 x per week

If you are looking for the opportunity to support Commercial Product Development through formulation development and technology transfer, keep reading!

As a Principal Scientist/ Investigator you will be responsible for developing biopharm drug product formulations, manufacturing processes and delivery systems for protein & peptide-based therapeutics, and play an important role to bring products from clinical development phase to commercialization.

Why you?

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Physicochemical and bioanalytical characterization of native and modified biopharm compounds (e.g., mAbs, bispecific mAbs, conjugated mAbs, etc.)
• Authoring & execution of non-GMP development stability protocols to test quality & stability of product formulations
• Developing drug product manufacturing processes, and technical transfer to manufacturing sites.
• Authoring and reviewing technical protocols, reports and regulatory documents in support of projects in various stages of development.
• Collaborating with internal & external development support partners
• Maintaining accurate, complete electronic laboratory records
• Facile use of electronic data & information gathering, capture, archiving and communication techniques
• Assisting in preparation and review of SOPs, and regulatory documentation

Basic Qualifications:

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

• PhD degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biology, Bioengineering, Biomedical engineering, or Chemical Engineering with protein formulation and drug delivery development experience or;
• MS degree with 5+ years of industry experience in drug delivery and/or development or;
• BS degree with 10+ years of industry experience in drug delivery and/or development
• Experience with authoring technical reports and documents

Preferred Qualifications:

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

• Experience or ability to interpret results from multiple bioanalytical techniques for product characterization and product stability evaluation, including SEC-HPLC and other HPLC methods, capillary electrophoresis & chip-based methods, Spectroscopy (e.g., UV/VIS, fluorescence, CD, etc.)
• Experience with both conventional and alternative biopharmaceutical protein formulation, and drug product development and stability evaluation, including the application of DOE and other statistically based experimental design/interpretation approaches.
• Experience with protein product manufacturing processes and development (e.g., solution in vial/PFS, or lyophilization); container/closure assessment & selection, drug delivery (e.g., combination product, device & administration kit) feasibility and compatibility evaluation.
• Experience with biophysical techniques for product characterization and stability evaluation is essential; including, e.g., Spectroscopy (UV/VIS, fluorescence, or CD), Differential Scanning Calorimetry, UNit/ UNcle, Prometheus, particles size evaluation (MFI, FlowCam, Archimedes), light scattering, Isothermal Calorimetry.
• Experience in authoring regulatory documentation (IND/IMPD, BLA/MAA, etc.); contributing to, and critical review of successful regulatory submissions; with particular emphasis on late clinical phase submissions, and response to regulatory questions.
• Experience in drug product manufacturing technology transfer to commercial and/or scale-up of clinical drug product manufacturing capabilities.
• Experience working with Biopharm combination products.
• Creative and motivated self-starter, with excellent verbal and written communication skills, demonstrated ability to work independently and ability to work effectively in team and matrix environments.
• Demonstrated ability to maintain accurate, complete laboratory records and facile use of electronic data & information gathering, capture, archiving and communications techniques.

#LI-GSK

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.