Scientist, Drug Product Development

Job description

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary Are you a scientist in sterile biopharm product formulation or process development, ready to contribute to the development of life-changing drug products? Are you eager to unite science, talent, and technology to get ahead of disease together? This may be the right opportunity for you! As a Scientist or Senior Scientist in the Formulation and Process Development department, within Drug Product Development at GSK, you will focus on developing world class patient-centric drug products through innovation, technology and strategic partnering. The successful candidate for this position will focus on biopharmaceutical drug product development for mAbs, bispecific mAbs, ADCs, etc. The department may also provide opportunities to contribute to development of small molecule drug products, including oligonucleotides. Role responsibilities will be focused on laboratory experimentation, with application of biophysical techniques and development stability studies to optimize protein formulations. Role responsibilities will also include formulation robustness studies, in-use evaluation to ensure product quality during product administration, performing process development studies (e.g., for mixing, sterile-filtration, filling, and where applicable, lyophilization). The role will also include contributing to tech transfer and scale-up for clinical and commercial drug product manufacturing. Responsibilities will include authoring of development protocols and technical reports and other related documentation, and supportive authoring of regulatory documents (e.g., sections of IND, IMPD, BLA, MAA). Responsibilities will involve working closely with internal & external development support partners (e.g., Analytical Development, Manufacturing Sciences and Technology, etc.), maintaining accurate, complete electronic laboratory records; facile use of electronic data & information gathering, capture, archiving and communications techniques. Key Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Designs and executes study protocols 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 an extensive theoretical understanding of a particular area of science. Develops understanding of regulatory requirements Complies with and contributes to document content and data integrity requirements Authors protocols, technical reports and sections of regulatory documentation Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: Bachelor’s degree with 2+ years of relevant laboratory-based experience or Master’s degree with 1+ years of relevant laboratory-based experience with the degree in Pharmaceutics, Biology, Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline Preferred Qualification Knowledge and/ or experience in protein chemistry/structure, protein formulation and drug delivery/device development, and drug product manufacturing (fill-finish) and process development Knowledge and/ or experience with in-use/administration compatibility studies Experience using biophysical or other techniques for product characterization and assessment of product stability (e.g., SLS, DLS, DSC, MFI, HIAC) Technical report writing and regulatory documentation authoring experience (IND/IMPD, BLA/MAA, etc.). Creative and motivated self-starter Strong organizational skills Maintains accurate and complete laboratory records Ability to work effectively in a team and matrix environment Excellent verbal communication and technical writing skills #GSK-LI Skills Drug Delivery, Laboratory Operations, Pharmaceutical Formulations, Quality by Design, Technical Writing 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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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 trans