At a Glance
- Tasks: Collaborate with teams to support drug manufacturing and execute technical strategies.
- Company: GSK, a leading global healthcare company focused on innovation.
- Benefits: Competitive salary, diverse work environment, and opportunities for professional growth.
- Other info: Equal opportunity employer committed to diversity and inclusion.
- Why this job: Join a dynamic team making a real impact in pharmaceutical manufacturing.
- Qualifications: Bachelor's degree in a scientific field and 5+ years in technical operations.
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.
- 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).
Basic Qualification
- 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 Qualification
- 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 (for example 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.
SME - MSAT EM Technical Operations DS/DP employer: Gsk
GSK is an exceptional employer, offering a dynamic work environment in King of Prussia, Pennsylvania, where innovation and collaboration thrive. Employees benefit from a strong focus on professional development, with opportunities for continuous improvement and technical training, all while contributing to meaningful projects in the pharmaceutical industry. The inclusive culture and commitment to excellence ensure that every team member can make a significant impact on global health.
StudySmarter Expert Advice🤫
We think this is how you could land SME - MSAT EM Technical Operations DS/DP
✨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 management confidently. We want you to shine when it comes to demonstrating your expertise!
✨Tip Number 3
Don’t forget to showcase your continuous improvement skills! Be ready to share examples of how you've led projects or initiatives that improved processes in your previous roles. This is key for standing out in the MSAT field.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged with our company. Let’s get you that dream job!
We think you need these skills to ace SME - MSAT EM Technical Operations DS/DP
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 lead technical investigations.
Showcase Continuous Improvement:We love seeing candidates who are passionate about continuous improvement. Be sure to include any projects or initiatives where you’ve successfully identified areas for enhancement, especially in manufacturing processes or compliance.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Gsk
✨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, especially around GMP compliance and analytical technologies. This will help you speak confidently about your experience and how it aligns with the role.
✨Showcase Your Collaboration Skills
Since this role involves working closely with internal and external stakeholders, be prepared to discuss specific examples of how you've successfully collaborated in the past. Think about times when you supported CMOs or led cross-functional teams, and be ready to share those stories.
✨Prepare for Technical Questions
Expect to face questions that dive deep into technical aspects like change control, deviation investigations, and CAPAs. Brush up on these topics and think of real-life scenarios where you applied these concepts. Being able to articulate your thought process will impress the interviewers.
✨Demonstrate Continuous Improvement Mindset
Highlight your experience with continuous improvement methodologies like Lean or Six Sigma. Be ready to discuss specific projects where you identified inefficiencies and implemented solutions. This shows that you're proactive and committed to enhancing processes, which is crucial for this role.
