Site Name: UK - Hertfordshire - Ware RD
Posted Date: May 24 2023

Scientific Leader, Drug Product Development (Oral & Inhaled)

GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to support our mission to improve the quality of human life by enabling people to do more, feel better and live longer.

We are looking for a Scientific Leader to join our Drug Product Development division at GSK’s R&D Site at Ware (Hertfordshire). Drug Product Development is a vibrant global group responsible for developing drug products from candidate selection of the molecule through to commercialisation. Aligned with Quality by Design (QbD) principles these products are designed to meet both patient needs and commercial manufacturing requirements. This role, based within our oral and inhaled Drug Product Development group at Ware, provides an exciting opportunity to contribute to the design and development of drug products across a number of disease areas and different clinical phases, as well as working closely with the commercial manufacturing organisation co-located at the Ware site.

Using your practical experience and scientific/technical expertise, you will be a key player in formulation and process development of oral products, including product and process design, experimental planning/execution and data interpretation. The role requires the ability to work effectively across a matrix, operating collaboratively with other departments and disciplines, where you will use your professional judgement to influence and determine the most appropriate course of action for small molecule project(s) based on science and risk-based principles, and always with a focus on the patient. As a technical expert, you will also be expected to proactively share knowledge across teams and departments. You may have supervisory responsibility for some scientists and, in a progressive department, instigate and lead department initiatives and new ways of working.

This role would suit a highly motivated individual who is suitably experienced in the development of drug product formulations and the associated manufacturing processes. You will be degree-educated with a track record of successful formulation and process development, excellent communication and interpersonal skills and exhibit a collaborative, continuous improvement mindset. You will exhibit a passion for scientific discovery, including use of scientific literature and acquired knowledge to assist product development and understanding. You will also have a strong history of line and/or project leadership.

In this role you will

• Design, lead, plan and perform phase appropriate development work packages for the required purpose and in line with QbD approaches (e.g. product and process understanding, clinical supplies, stability and regulatory).
• Uses scientific expertise to solve project-related problems within project technical and matrix teams, and to propose and deliver innovative approaches to achieve project goals.
• Captures and embeds technical learning for the benefit of current and future projects.
• Influences project directions by interpreting results, performing complex data management and analysis.
• Effectively summarises and communicates project status, risks, issues, and decisions, providing timely input to line management and project governance forums.
• Collaborates effectively with other teams/divisions within GSK to achieve project goals.
• Anticipates/recognizes potential problems with equipment and/or supplies, and initiates action to solve or prevent problems
• Responsible for leading significant aspects of technology transfer within/between R&D and GSK’s commercial supply sites (internal or external).
• Proactively ensures high quality and data integrity standards are employed in own work and the work of the team, including working to GMP principles.
• May be responsible for supervising work at a contractor or other remote facility.
• Leads or contributes to departmental ways of working initiatives.
• Independently prepares and communicates recommendations for next steps to relevant members of own team or Matrix Teams.
• Independently authors and reviews internal reports, content for patents, content for regulatory submissions and scientific papers.
• Demonstrates networking and team-building skills through interactions across departments and divisions.
• Proactively influence the department in own area of subject matter expertise.

• Adhere to Company safety policy and legal requirements, follow local rules and risk assessments, maintain safety training, and have full awareness of the safety requirements for laboratory/manufacturing working environments.

If supervisor:

• Leadership, motivation, training, performance management, personal development of those supervised and when necessary, recruitment of new team members.
• Ensure that the quality, quantity and delivery of the team’s work are to the necessary standards.
• Compliance with current GMPs, including the timely and reliable completion of experimental records and issuance of in accordance with company policy.
• Ensure detailed oral and written reports, tailored to the context and audience are prepared and issued.
• Ensure that the team always operate in a safe manner, in compliance with current company Health, Safety and Environmental policies and guidance.

Why you?

Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• BSc degree or equivalent (as a minimum) in an appropriate discipline.
• Deep understanding of product formulation, process design and process development.
• Proven ability to understand and influence all aspects of product development.
• Has thorough knowledge of regulatory requirements and the drug development process.
• Has thorough working knowledge of Quality by Design approaches and implements appropriate development strategies for projects.
• Effectiveness in influencing partners through the generation and presentation of options and trade-offs.

• Experience of supervising and delivering through direct reports and/or across a project matrix, with a desire to further develop line leadership skills.

Preferred Qualifications & Skills:

If you have the following characteristics, it would be a plus:

• Sought out as an expert and resource in their scientific field
• Demonstrated ability to influence projects outside of own team and is recognised by their internal peers outside of immediate work group as an expert in a specific scientific or technical area
• Has knowledge of related scientific disciplines as they apply to drug discovery/development and has general understanding of key scientific areas impacting project
• Has track record of moving project/function forward successfully
• Begins to evaluate potential innovative research areas

Closing Date for Applications: Wednesday 7th June 2023 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

During the course of your application, you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

#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 positively impact the health of 2.5 billion people by the end of 2030.

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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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