What are the responsibilities and job description for the Small Molecule Drug Substance Lead position at WIB-Pittsburgh?
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Small Molecule Drug Substance Lead
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GSK
King Of Prussia, Pennsylvania, United States
(on-site)
Small Molecule Drug Substance Lead
Share Print
GSK
King Of Prussia, Pennsylvania, United States
(on-site)
Posted 6 hours ago
Small Molecule Drug Substance Lead
Share Print
GSK
King Of Prussia, Pennsylvania, United States
(on-site)
Job Type
Full-Time
Job Function
Other
Small Molecule Drug Substance Lead
The insights provided are generated by AI and may contain inaccuracies. Please independently verify any critical information before relying on it.
Small Molecule Drug Substance Lead
The insights provided are generated by AI and may contain inaccuracies. Please independently verify any critical information before relying on it.
Description
Position Summary
You will lead small molecule drug substance activities from lab development through clinical and commercial manufacturing readiness. You will work closely with teams in process development, quality, regulatory, manufacturing and supply. We value practical scientific judgment, clear communication, and collaborative leadership. This role offers visible ownership, career growth, and the chance to make a meaningful impact by helping deliver safe, reliable medicines. Join us to unite science, technology and talent to get ahead of disease together.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Lead the drug substance workstream for small molecule programs, guiding process development, scale-up, and technology transfer.
- Build and maintain integrated development plans, milestones and decision points that support program timelines and regulatory expectations.
- Design and execute experiments for process characterization, robustness studies, and scale-up risk mitigation.
- Coordinate cross-functional teams and external partners to resolve technical issues and secure clinical and commercial supply readiness.
- Prepare clear technical summaries, risk assessments, and recommendations for project leadership and governance.
- Mentor colleagues, share practical knowledge, and promote inclusive ways of working.
- Collaborate with CMC, analytical development, quality, regulatory affairs, clinical supply, manufacturing, and external contract organizations.
- Engage suppliers, contract manufacturers and external labs to align technical approaches and timelines.
- Present program status, risks and mitigation plans to project teams and decision forums.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals
- Bachelor's degree in chemistry, chemical engineering, pharmaceutical sciences, or related field.
- Minimum 5 years industry experience in small molecule drug substance process development, scale-up, or CMC roles.
- Practical experience in technology transfer to manufacturing sites or CMOs.
- Knowledge of process design, process characterization concepts and control strategy development.
- Proven ability to lead cross-functional workstreams in a matrixed environment.
If you have the following characteristics, it would be a plus
- Clear written and verbal communication skills for diverse technical and business audiences.
- Advanced degree (MS or PhD) in chemistry, chemical engineering, or pharmaceutical sciences.
- Experience in late-stage development, regulatory submissions or supporting regulatory interactions.
- Experience with high-potency compounds, specialized handling, or complex purification processes.
- Formal project management training or experience managing multi-site transfers.
- Track record of mentoring or leading small technical teams.
- Familiarity with quality systems, risk management, and data integrity principles.
- This role is hybrid in the United States. Expect regular on-site work combined with focused remote time. On-site presence is required for lab, manufacturing or key team activities.
- You put patient impact and safety at the center of your decisions.
- You communicate clearly and make practical, evidence-based recommendations.
- You build collaborative relationships and work with humility.
- You learn from experience and share knowledge to raise team capability.
- You demonstrate inclusive behavior and support a culture of inclusion.
If this role matches your skills and career goals, we encourage you to apply. We welcome candidates who bring scientific leadership, practical problem solving and a commitment to improving patient outcomes. We look forward to hearing from you.
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 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 https://openpaymentsdata.cms.gov/
Job ID: 84863590
GSK
Websitewww.gsk.com US Headquarters: Philadelphia, PA Size:10000 employees Founded: 1830 Type: Company - Public (GSK) Industry: Biotech & Pharmaceuticals Revenue: $10 billion (USD) per year Video: https://youtu.be/RBdgq5VTQmM We are a science-led global healthcare company. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. We also have a significant global presence with commercial operations in more than 150 countries, a netwo...
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