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- Tasks: Collaborate on technical strategies for drug manufacturing and support lifecycle activities.
- Company: Join GSK, a leader in pharmaceutical innovation and global supply chain excellence.
- Benefits: Comprehensive benefits package and opportunities for professional growth.
- Other info: Diverse and inclusive workplace with a focus on continuous improvement.
- Why this job: Make a real impact in the pharmaceutical industry with cutting-edge technology.
- Qualifications: Bachelor's degree in a scientific field and 5+ years in drug operations required.
The predicted salary is between 60000 - 80000 £ 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. As an accountable Subject Matter Expert (SME), this role will collaborate closely with internal and external stakeholders, to support the ongoing commercial manufacture of large molecule Drug substance and/or sterile Drug Product, ensuring technical lifecycle support and execute MSAT/EM technical strategy and activities for manufacturing processes including routine operation, field, technical support, and validation.
Responsibilities
- Execute technical strategy and represent MSAT Technical Operations for External Manufacturing in relevant PQTS teams.
- Ensure support for CMOs in establishing maintenance, performance of standards, and technical transfers of established products or transfers between CMOs.
- Support CMO for audit documentation, inspection readiness, and prepare local teams during audits.
- Ensure critical lifecycle activities:
- CPV Change control
- Deviation investigation and resolution
- CAPAs
- Waste mapping
- Performance of standards
- Continuous Improvement (financial, process, etc)
Qualifications
- Bachelor's degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related scientific field.
- 5+ years' experience in drug substance and/or drug product (including device) technical operations in pharmaceutical or biologics manufacturing.
- Experience of the pharmaceutical current best practice in analytical and manufacturing technologies, validation and GMP compliance.
- Experience with managing product life cycle activities.
- Lead technical investigations, perform root cause analysis, manage change control, and develop corrective and preventive actions (CAPA).
- Experience collaborating with external manufacturing partners.
Preferred:
- Advanced degree (Master's or PhD) in a relevant scientific or engineering discipline.
- Demonstrated success identifying and leading continuous improvement.
- Certification or formal training in project management, risk management, or continuous improvement methods (e.g., Lean or Six Sigma).
- Experience supporting regulatory inspections and preparing technical responses.
- Proven track record of successful technology transfers to CMOs or external partners.
- Experience coaching and developing technical capability across multi-site or global teams.
Comprehensive benefits program available for US employees. 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.
SME - MSAT EM Technical Operations DS/DP in Ware employer: WISE Campaign
Contact Detail:
WISE Campaign Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land SME - MSAT EM Technical Operations DS/DP in Ware
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in MSAT or related fields. A friendly chat can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge. Make sure you can discuss drug substance and product lifecycle activities confidently. We want you to shine when they ask about your experience with GMP compliance and technical investigations!
✨Tip Number 3
Showcase your continuous improvement mindset! Be ready to share examples of how you've led projects or initiatives that improved processes or outcomes. This is key in the MSAT world, and we know you’ve got some great stories to tell.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our team and contributing to GSK's goals.
We think you need these skills to ace SME - MSAT EM Technical Operations DS/DP in Ware
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the job description. Highlight your experience in drug substance and drug product technical operations, and don’t forget to mention any relevant qualifications or certifications that align 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 the perfect fit for the SME role. Share specific examples of your past experiences that demonstrate your ability to collaborate with stakeholders and manage product lifecycle activities.
Showcase Your Technical Skills: We want to see your technical expertise! Be sure to include any experience you have with GMP compliance, validation, and continuous improvement methods like Lean or Six Sigma. This will help us understand how you can contribute to our MSAT team.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensure it gets the attention it deserves. Plus, it shows you’re serious about joining our team!
How to prepare for a job interview at WISE Campaign
✨Know Your Stuff
Make sure you brush up on your knowledge of drug substance and drug product technical operations. Familiarise yourself with the latest trends in pharmaceutical manufacturing, GMP compliance, and analytical technologies. This will help you answer questions confidently and demonstrate your expertise.
✨Showcase Your Collaboration Skills
Since this role involves working closely with internal and external stakeholders, be prepared to discuss your experience in collaboration. Think of specific examples where you've successfully worked with teams or partners to achieve a common goal, especially in technical transfers or audits.
✨Prepare for Technical Questions
Expect to face technical questions related to lifecycle activities, change control, and CAPA processes. Review your past experiences and be ready to explain how you've handled deviations or led investigations. Use the STAR method (Situation, Task, Action, Result) to structure your answers.
✨Demonstrate Continuous Improvement Mindset
Highlight any experience you have with continuous improvement methodologies like Lean or Six Sigma. Be ready to share examples of how you've identified areas for improvement and implemented changes that positively impacted processes or outcomes in your previous roles.