At a Glance
- Tasks: Lead E&L assessments and collaborate with labs for biopharmaceutical testing.
- Company: Join GSK, a global leader in healthcare innovation.
- Benefits: Competitive salary, annual bonus, share-based incentives, and inclusive culture.
- Other info: Diverse team with opportunities for growth across geographies and cultures.
- Why this job: Make a real impact in drug development and compliance in a dynamic environment.
- Qualifications: Bachelor’s degree in a scientific field and 5+ years of E&L experience required.
The predicted salary is between 70650 - 117750 € per year.
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- 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.
- Manage 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.
- 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.
- 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.
Specialist - Extractables and Leachable - MSAT EM in Ware employer: Gsk
GSK is an exceptional employer that fosters a collaborative and innovative work culture, particularly in the dynamic field of biopharmaceuticals. With a strong commitment to employee growth, GSK offers comprehensive training and development opportunities, competitive salaries, and a supportive environment that values diversity and inclusion. Located in Upper Merion, Belgium, and Wavre, UK, employees benefit from a strategic role in global supply chain operations, contributing to meaningful advancements in healthcare while enjoying a competitive benefits package including bonuses and share-based incentives.
StudySmarter Expert Advice🤫
We think this is how you could land Specialist - Extractables and Leachable - MSAT EM in Ware
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work with E&L assessments. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP compliance and E&L testing. We recommend creating a list of common interview questions and practising your responses to show off your expertise.
✨Tip Number 3
Don’t forget to showcase your soft skills! Communication and prioritisation are key in this role, so be ready to share examples of how you’ve effectively collaborated across teams or managed multiple projects.
✨Tip Number 4
Apply through our website for the best chance at landing that Specialist role! It’s the quickest way to get your application in front of the right people and shows you’re serious about joining the GSK team.
We think you need these skills to ace Specialist - Extractables and Leachable - MSAT EM in Ware
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Specialist - Extractables and Leachable role. Highlight your relevant experience in E&L assessments and any specific projects that align with the job description. We want to see how your background fits perfectly with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your skills can contribute to our team. Be sure to mention your experience with GMP compliance and working with CMOs, as these are key aspects of the position.
Showcase Your Communication Skills:Since strong verbal and written communication skills are essential for this role, make sure your application reflects that. Use clear and concise language, and don’t hesitate to demonstrate your ability to convey complex information effectively. We love a good communicator!
Apply Through Our Website:We encourage you to apply through our website for the best chance of being noticed. It’s straightforward and ensures your application goes directly to us. Plus, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Gsk
✨Know Your E&L Inside Out
Make sure you brush up on your knowledge of extractables and leachables, especially in the context of biopharmaceuticals. Be prepared to discuss specific methodologies you've used in past assessments and how they align with current best practices.
✨Showcase Your Compliance Knowledge
Familiarise yourself with GSK's Quality Management System (QMS) and Good Manufacturing Practices (GMP). During the interview, highlight your experience with compliance and how you've ensured adherence to both internal and external requirements in previous roles.
✨Communicate Clearly and Confidently
Strong verbal and written communication skills are crucial for this role. Practice articulating complex technical information in a clear and concise manner. You might even want to prepare a few examples of how you've effectively communicated with diverse teams or stakeholders.
✨Demonstrate Your Problem-Solving Skills
Be ready to discuss specific challenges you've faced in E&L assessments and how you approached them. Highlight your ability to identify risks and escalate issues appropriately, showcasing your strategic thinking and decision-making skills.
