CMC Development and Industrialization Leader

Site Name: USA - Pennsylvania - Upper Providence, GSK House, Stevenage

Posted Date: Mar

Are you interested in a highly visible leadership role, supporting delivery of our innovative portfolio of biopharmaceutical assets? If so, this CMC Development and Industrialization Leader role is an exciting move to explore. This opportunity will allow you to influence the development strategy, lead delivery of the CMC, supply chain and regulatory targets, lead the high performing matrix team; and shape the medicine and help patients.

The Role

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 plan for a new medicine. The successful candidate will join the Large Molecule Medicine Development & Industrialisation team, taking on a significant asset in our biopharmaceutical portfolio.

Leads CMC development and industrialisation of a medicine:

• Leads the definition and implementation of the global CMC development and industrialisation strategy and plan for a key medicine, aligning with the global medicine development strategy and plan, the needs of the patient, the commercial intent for the medicine, the overall business context and the regulatory, compliance and manufacturing network requirements.
• Provides options for CMC delivery to align with the project objectives, with recommendations based on sound judgement on both short- and long-term implications (risks, costs, resources and time) for the global lifecycle of the medicine.
• Anticipates, and appropriately plans for, future CMC requirements and risks to enable the full global clinical and commercial lifecycle of the medicine.

Leads the CMC matrix team:

• Leads the cross-functional multi-disciplinary CMC matrix team (10 core team members from R&D and GSC encompassing technical, quality, regulatory, supply chain and manufacturing; 50 extended team members) to develop and execute the CMC project plans to accomplish the project aligned objectives to time, budget and resource forecasts.
• Owns the performance of the CMC matrix team: partners 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.
• Scope of activities covered by CMC matrix team:
• Development of the physical product, process, device and analytical methods.
• Establishment of the clinical and commercial supply chains, manufacturing processes and control strategies.
• Supply of clinical and initial commercial material.
• Clinical and commercial pack and label.
• Transfer of the process and methods from R&D to first commercial manufacture/testing site.
• Definition and delivery of the CMC regulatory strategy, submissions and responses to regulatory questions
• Launch readiness.

Voice of CMC for the project:

• Provides the voice of the physical product and supply chain to influence the medicine development and commercialisation strategies and plans, ensuring appropriately gated commitment to, and investment in, CMC activities.
• Provides the voice of the project to the CMC matrix team to align the CMC plans with the project intent and corporate goals, and to the CMC and commercial manufacturing functional lines to ensure they have the capability and capacity to deliver.
• Aligns senior leaders across R&D and GSC (via governance bodies) on the strategic CMC objectives, plans and risk mitigation activities for the project and the investments and resources required to deliver these.
• Integrates across R&D and GSC to deliver the project via the CMC Matrix Team and close communication with senior stakeholders.
• Provides CMC input to due diligence reviews of new asset business development proposals, positioning the CMC opportunities and risks in the context of the proposed medicine and business strategy.

Skills and competencies

This role requires the knowledge, gravitas, 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.

An exceptional matrix leader:

• Sets direction, empowers others to take ownership of their activities, monitors progress, knows when and how to intervene to avoid or manage risks and issues, helps remove barriers, holds team members accountable for their delivery and performance on behalf of the team and the enterprise.
• A curious scientific intellect, a critical thinker with sound judgement.
• Strong decision-making skills.
• An agile and willing learner.
• Creative problem solver: able to analyse and interpret complex situations to provide appropriate innovative solutions and clear strategic direction to others.
• An active and empathetic listener who is aware of own limitations in knowledge, expertise or experience.
• Able to influence at very senior levels in the business and across multiple disciplines
• Masterful manager of conflict.
• Collaborative, cooperative, inclusive and transparent, builds and cultivates high performing teams and partnerships.
• Excellent communicator both verbal and written.

A highly credible CMC or supply chain expert:

• Strong technical knowledge of process, product and analytical development
• Strong CMC regulatory or compliance knowledge
• Strong knowledge of commercial supply chain implementation.
• Awareness of compliance and regulatory requirements for clinical and commercial manufacturing.
• Advanced knowledge of the drug development process.
• Awareness of CMC as part of the whole, with a broad knowledge of the E2E non-clinical, clinical, regulatory and commercial aspects of developing a medicine.
• Analyses, interprets and critically evaluates data and information to determine and justify decisions or recommendations.

Business savvy:

• Connected to the broader business with a wide internal and external network.
• Able to balance scientific, technical and manufacturing risks against the overall business impact.
• Understands the business financial context within which decisions are made.

Experience

• Significant experience working in a CMC or supply chain organisation (e.g. process, product or analytical development, manufacturing, supply chain, quality, CMC regulatory).
• Recognised internally, and preferably externally, as a thought leader or subject matter expert in a relevant CMC discipline.
• Experience in CMC medicine development, particularly late stage and preferably through to successful product approval and launch.
• Successful developer of people as a mentor, coach, matrix or line leader.
• Successfully led large, complex, cross-functional teams, with high level of accountability, preferably in an international context and preferably with external partners.
• Significant experience working directly with senior executives.

Why you?

Basic qualifications:

• Bachelor of Science with director level CMC experience in the development or manufacture of relevant biopharmaceuticals.
• Excellent knowledge, through experience, of the relevant CMC and supply chain aspects of developing, manufacturing and industrializing biopharmaceuticals along with a thorough working knowledge of the pharmaceutical industry, relevant regulations and requirements.
• Experience creating and defending CMC development strategy, plan and data package for an asset.
• Project leadership experience, specifically leadership of multi-disciplinary teams and preferably in a relevant pharmaceutical product development environment with global teams.
• Experience working at a senior level with both internal and external groups.

Preferred qualifications:

• PhD/EngD with senior director level and extensive CMC experience in the development or manufacture of relevant biopharmaceuticals.

Learning agility and desire to learn new things outside of one's comfort zone; willingness to take on diverse and agnostic assignments in product development

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

#LI-GSK

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).

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 status or any other federal, state or local protected class.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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 GSK's Transparency Reporting For the Record site.