Specialist - Extractables and Leachable - MSAT EM

Location: Ware
Time type: Full time

The Global Manufacturing Science and Technology (MSAT) organization is a network focused function which provides strategic direction, technical and operations support to ensure that GSK Global Supply Chain network goals and objectives are achieved, through a focused strategy execution.

The Senior Specialist – Extractables and Leachable role acts as a global SME support for Large Molecule and Vaccine drug substance and drug product programs for GSK’s External Manufacturing network.

Responsibilities
This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include some of the following:

• Work with internal and external laboratories to ensure E&L testing is completed in a scientific, compliant and cost effective manner.
• Conduct and document E&L risk assessments for biopharmaceutical manufacturing processes, container closure systems, and dosing devices.
• Deliver key technical information to business partners, to support business decisions and/or regulatory filings.
• Manages risk identification and escalation to the GSK stakeholders.
• Ensure compliance with external and internal requirements (e.g. GSK QMS, GSK GQSOPs) through interaction with internal organization

Why You?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor’s degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related scientific field.
• 5+ years’ experience in leading E&L assessments.
• Experience of the pharmaceutical current best practice in analytical and manufacturing technologies, validation and GMP compliance.

Preferred Qualification

• Advanced degree (Master’s or PhD) in a relevant scientific or engineering discipline.
• Experience working with contract manufacturing organizations (CMOs).
• Demonstrated ability to work effectively across a diverse customer base.
• Awareness of FDA, US Pharma and Good Manufacturing Practices (GMP) requirements related to packaging.
• Ability to work effectively in a matrix organization across geographies and cultures.
• Strong verbal and written communication skills.
• Prioritization skills.

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.

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.