Principal Scientist, Sterile Drug Product Development

Principal Scientist, Sterile Drug Product Development 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’ 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 drug product development eager to lead 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! Formulation and Process Development, within the Drug Product Development (DPD) department, is part of the wider R&D Drug Development and Supply organization, and is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive product 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 large molecule (biopharma) drug product development. We also pioneer innovative technologies and employ data science to improve robustness, reduce cost of goods, and improve the patient experience. Within Drug Product Development (DPD), the Formulation and Process Development (FPD) 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 drug product development for protein (e.g., mAbs, bispecific mAbs, antibody‑drug‑conjugates (ADCs)) and peptide‑based therapeutics. This role will focus on drug product development for assets being developed for Clinical Phases 2 and 3, and commercialization. Associated activities may include protein formulation optimization and development stability assessment, in‑use compatibility/stability assessments to support product administration, drug product process development, characterization, and technical transfer activities to a GMP manufacturing facility. Role responsibilities may include matrix leadership and working with other departments to progress drug product development. Responsibilities may also include laboratory experimentation, with application of biophysical techniques and development (non‑GMP) stability studies to optimize protein formulation. The position will also require authoring of technical and regulatory documents, maintaining accurate, complete electronic laboratory records; facile use of electronic data & information gathering, capture, archiving and communications techniques. Because the department encompasses both small molecule and large molecule (biopharma) development, there may also be opportunities to contribute to development of small molecule drug products (e.g., chemical entities and oligonucleotides). Why you? 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 0+ years of protein formulation and/or process development or, MS degree with 5+ years of industry experience; or, BS degree with 7+ years of industry experience. Experience in authoring technical documents Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience working with antibody‑drug‑conjugates (ADCs). Experience or ability to interpret results from multiple bioanalytical techniques for product characterization and product stability evaluation. Experience with both conventional and alternative biopharmaceutical protein formulation and drug product stability evaluation, including the application of DOE and other statistically based experimental design/interpretation approaches. Experience with protein drug 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 valuable, e.g., DSC, DSF (experience with Uncle or Prometheus Panta), particles size evaluation (MFI, FlowCam), light scattering, etc. 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. Experience maintaining accurate, complete laboratory records and facile use of electronic data & information gathering, capture, archiving and communications techniques.

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Skills Drug Delivery, External Manufacturing, Medical Device Evaluation, Molecular Modeling, Pharmaceutical Formulations, Pharmacokinetics, Product Design, Product Management, Product Planning, Product Strategies, Quality by Design, Regulatory Filings, Stability Testing, Technology Transfer 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’ 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 drug product development eager to lead 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! Formulation and Process Development, within the Drug Product Development (DPD) department, is part of the wider R&D Drug Development and Supply organization, and is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive product 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 large molecule (biopharma) drug product development. We also pioneer innovative technologies and employ data science to improve robustness, reduce cost of goods, and improve the patient experience. Within Drug Product Development (DPD), the Formulation and Process Development (FPD) 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 drug product development for protein (e.g., mAbs, bispecific mAbs, antibody‑drug‑conjugates (ADCs)) and peptide‑based therapeutics. This role will focus on drug product development for assets being developed for Clinical Phases 2 and 3, and commercialization. Associated activities may include protein formulation optimization and development stability assessment, in‑use compatibility/stability assessments to support product administration, drug product process development, characterization, and technical transfer activities to a GMP manufacturing facility. Role responsibilities may include matrix leadership and working with other departments to progress drug product development. Responsibilities may also include laboratory experimentation, with application of biophysical techniques and development (non‑GMP) stability studies to optimize protein formulation. The position will also require authoring of technical and regulatory documents, maintaining accurate, complete electronic laboratory records; facile use of electronic data & information gathering, capture, archiving and communications techniques. Because the department encompasses both small molecule and large molecule (biopharma) development, there may also be opportunities to contribute to development of small molecule drug products (e.g., chemical entities and oligonucleotides). Why you? 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 0+ years of protein formulation and/or process development or, MS degree with 5+ years of industry experience; or, BS degree with 7+ years of industry experience. Experience in authoring technical documents Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience working with antibody‑drug‑conjugates (ADCs). Experience or ability to interpret results from multiple bioanalytical techniques for product characterization and product stability evaluation. Experience with both conventional and alternative biopharmaceutical protein formulation and drug product stability evaluation, including the application of DOE and other statistically based experimental design/interpretation approaches. Experience with protein drug 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 valuable, e.g., DSC, DSF (experience with Uncle or Prometheus Panta), particles size evaluation (MFI, FlowCam), light scattering, etc. 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. Experience maintaining accurate, complete laboratory records and facile use of electronic data & information gathering, capture, archiving and communications techniques.

#GSK-LI

Skills Drug Delivery, External Manufacturing, Medical Device Evaluation, Molecular Modeling, Pharmaceutical Formulations, Pharmacokinetics, Product Design, Product Management, Product Planning, Product Strategies, Quality by Design, Regulatory Filings, Stability Testing, Technology Transfer 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 View email address on click.appcast.io 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 transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at Helping all candidates find great careers is our goal. The information you provide here is secure and confidential. We are now directing you to the original job posting. Please apply directly for this job at the employer’s website. #J-18808-Ljbffr GlaxoSmithKline