Site Name: USA - Pennsylvania - King of Prussia Posted Date: Dec 19 2024 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 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 based therapeutics and contributes to defining scientific strategy across projects/initiatives. This role may include protein formulation development and optimization, stability and shelf-life assessment, and drug product process development, characterization, and technology transfer activities. The role will require leadership skills including expectations to lead a matrix team involved with the transfer, validation, and commercialization of drug product manufacturing processes. The role may require management of a direct report or reports. The position may include externalization of some work packages to key partners of the Drug product development organization in both the US and the UK. The position will also require flexibility to handle non-project specific initiatives to support the department, and expectations for networking with the wider scientific community. Specific responsibilities will be focused on: Supporting the progression of the late phase portfolio including managing assets from Phase 2 through commercialization, included serving as drug product workstream lead and/or technical transfer lead in a matrix team environment. The position will include taking a lead role in drug product manufacturing process development, characterization, and tech transfer to GSK internal sites and/or external contractors. The position will require development of the drug product manufacturing control strategy, and authoring sections of regulatory submissions. Mentoring and developing junior staff in generating scientific protocols and reports will also be required. Additional responsibilities will include development/optimizing protein formulations for commercialization, providing strategic input for stability protocols, shelf-life setting, product comparability, and specifications. Maintaining accurate, complete laboratory records/ reports with a high level of data integrity following ALCOA+ principles; embody the GSK values and expectations; facile use of electronic data & information gathering, capture, archiving and communications techniques; and, assisting in preparation and review of SOPs, and regulatory documentation, as appropriate. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline with 7+ years of protein formulation and drug delivery development experience. or MS degree with 10+ years of protein formulation and drug delivery development experience. or BS degree with 15+ years of protein formulation and drug delivery development experience. Experience in authoring technical reports and regulatory documentation (IND/IMPD, BLA/MAA, etc.) Preferred Qualifications: Creative and motivated self-starter, with excellent verbal and written communication skills, demonstrated ability to work independently and across organizational and geographic boundaries as well as work effectively in team and matrix environments. Ability to demonstrate the ability for sound and timely decision-making and problem-solving skills in high impact situations. The candidate must demonstrate facile use of electronic data & information gathering, capture, archiving and communications techniques. Knowledge around current regulatory expectations and requirements to commercialize biopharmaceutical drug products including combination products. Expertise in establishing overall strategy for late phase Biopharm drug products and drug device combination products. Proven ability to lead collaboratively in a matrix environment. Authoring (or co-authoring) of publication(s) in peer-reviewed scientific journals. In-depth understanding of biopharmaceutical product development including formulation, stability, process development/characterization and technology transfer and PPQ. Familiarity with areas of bioanalytical and biophysical testing, and data analysis Demonstration of data integrity principles Provide scientific direction and mentorship to scientists in the group on projects, study design, execution, and report writing. Experience with technical risk assessments (FMEA) and control strategy development. Good knowledge of QbD as presented in regulatory dossiers. Experience conducting root cause analyses and investigations. #LI-GSK Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). 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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey 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. 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. 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