Senior Scientist, Sterile Drug Product Development - Hertfordshire, United Kingdom - GlaxoSmithKline

Description

Site Name: UK - Hertfordshire - Ware RD
Posted Date: Jun

Senior Scientist, Sterile Drug Product Development

If you are looking for an exciting opportunity to make a difference in the lives of patients by applying Drug Product development knowledge, expertise, and organisational skills to support patient focused product development to get ahead of disease together, this might just be the role for you.

As a Senior Scientist, Sterile Drug Product Development, in a rapidly growing, empowered, innovative and agile Strategic External Development organization developing transformative medicines, you will learn and contribute to internal and external development and manufacture of the company's Drug Products. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

In this role you will

Have the opportunity to contribute to the below key activities:

• Develop robust Drug Product formulations & processes to meet development milestones from candidate selection through commercialisation in accordance with regulatory guidance.
• In partnership with internal and external partners, contribute to drug product development and manufacturing efforts including leading work packages for sterile biopharm/oligonucleotide drug product programs of GSK's development portfolio.
• Build strong relationships with key internal and external stakeholders to help facilitate the delivery of DP objectives. Participate in a highly cross-functional internal and external CMC team environment.
• Develop and communicate program updates, challenges and opportunities and risk mitigation plans where necessary. Preparing oral or written summaries of results with interpretation for project work. Presenting effectively to internal GSK forums and external meetings.
• Support clinical supply manufacturing, batch record development, change control implementation, formal risk assessments and technical investigations. Provide virtual and/or on-site support for process development/scale-up/transfer activities at internal and external sites.
• Design and deliver experimental strategy/plans using QbD principles, perform data trending and analysis and interpret results, prepare/review development reports and contribute to preparing regulatory documents.
• Demonstrating timely and reliable recording of data/results in suitable systems in accordance with company policy and legal requirements. Performing data management and data stewardship to ensure high quality and traceable work.
• Support knowledge management strategies and execution needed for regulatory filings and a commercially viable drug product. Participate in authoring CMC sections of regulatory documents.

Why you?

Qualifications & Skills:

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

• Bachelor's (minimum), Master's /PhD (preferred) in Pharmaceutical Sciences, Chemistry, Biochemistry, Engineering, Materials Science or related scientific discipline required.
• Experience in Drug product development, manufacture (fill/finish) and/or commercialisation of sterile drug products or other modalities. Knowledge or experience of Oral Solid Dose (OSD) form development would be a plus but not required.
• Growing Knowledge of QbD principles, and regulatory requirements of Drug Product Development and manufacture across the global markets.
• Demonstrated behaviour of being agile, resilient and growth mindset, managing self-performance and development. Knowledge and / or experience in continuous improvement initiatives and change management.
• Demonstrated strong organizational skills with high initiative, strong drive and follow -through.
• Excellent oral and written communication skills, and the ability to effectively interface with project technical leads, departmental leads, and team members within the company and external partners.
• Demonstrated collaborative behaviours working in a functional and cross-functional teams.
• Experience in identifying, developing, and applying innovative solutions to scientific and technological problems by applying technical/analytical skills.

This role will require a flexible work schedule to accommodate program priorities and international activities as needed and Travel (some international) will be required.

Closing Date for Applications: June 30th, 2024 (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.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.

Find out more:

Our approach to R&D .

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, it's 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.

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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