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

• 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.

#LI-GSK

Belgium Salary Range / Fourchette salariale – Belgique: EUR 70,650 to EUR 117,750 The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

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 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.

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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.

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