Principal Scientist

GlaxoSmithKline; Upper Providence (Delaware County); On-site; USD 150,000 - 210,000; Full time

Job summary

GlaxoSmithKline seeks a lead for Formulation and Process Development in Drug Product Development. You will drive biopharmaceutical drug product development for protein-based assets, including ADCs, ensuring robust processes across clinical phases and the handover to GMP manufacturing.

The role requires a PhD or advanced degree with industry experience and expertise in regulatory submissions, protein formulation, and stability evaluation.

Qualifications

• PhD or MS with industry experience as described; or BS with 7+ years of industry experience.
• Experience in authoring regulatory documents (IND/IMPD, etc.).

Responsibilities

• Lead biopharmaceutical drug product development for protein and peptide-based assets.
• Coordinate with internal departments and external partners to progress development.
• Author technical and regulatory documents and support tech transfer to GMP facilities.

Skills

Drug Delivery

External Manufacturing

Medical Device Evaluation

Pharmaceutical Formulations

Pharmacokinetics

Product Design

Product Planning

Product Strategies

Quality by Design

Regulatory Filings

Stability Testing

Technology Transfer

Education

PhD in Pharmaceutical Sciences

MS in Chemistry/Biochemistry/Biology/Bioengineering

BS in Chemical Engineering/Related Field

Tools

DSC

DSF

Uncle/Prometheus Panta

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’s 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?

• matrix leadership and working with other departments to progress drug product development.
• laboratory experimentation, with application of biophysical techniques and development (non-GMP) stability studies to optimize protein formulation.
• authoring of technical and regulatory documents, maintaining accurate, complete electronic laboratory records; facile use of electronic data & information gathering, capture, archiving and communications techniques.
• opportunities to contribute to development of small molecule drug products (e.g., chemical entities and oligonucleotides).

Basic Qualifications

• 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

• 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.

#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.

Equal Opportunity Statement

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.