CMC Leader

GlaxoSmithKline LLC

Reference #: 398086
Site Name: USA – Pennsylvania – Upper Providence
Posted Date: Jun 7 2024

Are you energized by a highly visible leadership role that allows you to deliver our innovative portfolio of biopharmaceutical assets?  If so, this CMC Development and Industrialization Leader role is an exciting move to explore!

As a Biopharmaceutical CMC Leader, you will lead delivery of the CMC development, supply, and regulatory plans with a high performing matrix team to deliver innovative medicines to patients. This role requires the knowledge, courage, and credibility to lead a high performing multi-disciplinary matrix team of CMC and supply chain experts to develop and deliver the manufacturing process, supply chain, physical medicinal product, and regulatory submissions to enable clinical trials, regulatory approval, and a secure commercial supply of a medicine.

This is a critical leadership position in GSK, leading across R&D and Global Supply Chain (GSC), defining, and delivering the global CMC strategy and plans for a new medicine. The successful candidate will join the Large Molecule Medicine Development & Industrialization team, leading significant biopharm medicines and driving cross-portfolio improvements.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

Lead CMC development and industrialization of a medicine:
Lead the definition and delivery of global CMC strategy and plan for a key medicine, aligning with global medicine strategy, patient needs, commercial intent, overall business context and regulatory, compliance and manufacturing network requirements.
Provide options for CMC delivery to align with the project objectives, with recommendations on implications (risks, costs, resources and time) for the global lifecycle of the medicine.
Leads the CMC matrix team:
Lead cross-functional multi-disciplinary CMC matrix team (~10 core and ~50 extended members) to develop and deliver CMC project plans to time, budget and resource forecasts.
Own the performance of the CMC matrix team: partner with line managers to appropriately resource the project with the right expertise, and to develop and support the core and extended team members to drive performance and deliver the project.
Be the Voice of CMC for the project:
Influence medicine development and commercialization plans and appropriate investment in CMC activities, and to the functional lines to ensure capability and capacity to deliver.
Provide CMC input to due diligence reviews of business development proposals, including opportunities and risks in the context of the proposed medicine and business strategy.
Provide Enterprise leadership of product portfolio and CMC Operating Model:
Understand cross-portfolio CMC performance, identify and drive strategic improvements.
Align senior leaders across R&D and GSC on strategic CMC plans and risk mitigation activities and the investments and resources required to deliver.

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor of Science in a relevant science or engineering discipline
10 years experience in biopharm CMC development, manufacture, supply and regulations
2 years line and/or matrix leadership experience of multi-disciplinary global teams
Director level experience working with both internal and external partners and senior leaders

Preferred Qualifications:
If you have the following characteristics, it would be a plus:
MS/MBA or PhD/EngD with director level leadership experience in the development or manufacture of biopharmaceuticals
Strong communicator, decision maker, agile learner, masterful manager of conflict
Able to analyze complex situations to provide innovative solutions and clear direction
Able to influence at very senior levels in the business and across multiple disciplines
Collaborative, inclus ve and transparent, builds and cultivates high performing partnerships
Strong knowledge of biopharm development, manufacturing, supply chain, and quality
Knowledge of E2E non-clinical, clinical, regulatory and commercial aspects of development

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, its 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).

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 GSKs 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 GSKs compliance to all federal and state US Transparency requirements. For more information, please visit GSKs Transparency Reporting For the Record site.

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 sta

Show Full Vacancy