At a Glance
- Tasks: Lead technical operations and support the manufacture of innovative drug products.
- Company: Join GSK, a global leader in pharmaceuticals with a commitment to innovation.
- Benefits: Competitive salary, diverse workplace, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement and career development.
- Why this job: Make a real impact in healthcare by ensuring quality in drug manufacturing.
- Qualifications: 7+ years in pharmaceutical operations and a relevant degree required.
The predicted salary is between 70000 - 90000 € 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 Senior Subject Matter Expert (SME), this role will:
- Collaborate closely with internal and external stakeholders, to support the ongoing commercial manufacture of large molecule Drug substances 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 Qualifications:
- Bachelor’s degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related scientific field.
- 7+ 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 in identifying and leading continuous improvement.
- Lead technical investigations, perform root cause analysis, manage change control, and develop corrective and preventive actions (CAPA).
- Experience collaborating with external manufacturing partners.
Preferred Qualifications:
- Advanced degree (Master’s or PhD) in a relevant scientific or engineering discipline.
- 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.
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.
Senior SME - MSAT EM Tech Ops DS DP in Ware 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 that impact global health. The inclusive culture and commitment to diversity ensure that every team member feels valued and empowered to make a difference.
StudySmarter Expert Advice🤫
We think this is how you could land Senior SME - MSAT EM Tech Ops 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 and recent advancements in drug substance and product manufacturing. We want you to showcase your expertise and how it aligns with the role!
✨Tip Number 3
Don’t just wait for job postings! Be proactive and reach out to companies directly through our website. Express your interest in potential roles and highlight how your experience can benefit their team.
✨Tip Number 4
Practice your pitch! You’ll want to clearly articulate your experience in technical operations and continuous improvement methods. We’re here to help you refine your message so you can impress during interviews.
We think you need these skills to ace Senior SME - MSAT EM Tech Ops DS DP in Ware
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior SME role. Highlight your experience in drug substance and product technical operations, and don’t forget to mention any relevant projects or achievements that align with the job description.
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 role. Mention your collaboration skills and how you’ve successfully supported CMOs in the past. Keep it engaging and professional!
Showcase Your Technical Expertise:In your application, be sure to showcase your technical expertise in pharmaceutical manufacturing and compliance. Discuss any experience you have with continuous improvement methods like Lean or Six Sigma, as this will set you apart from other candidates.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It’s the best way to ensure your application gets into the right hands and shows us you’re serious about joining our team!
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 manufacturing processes. Familiarise yourself with the latest trends in pharmaceutical technologies and GMP compliance, as these will likely come up during the interview.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience in technical operations, continuous improvement, and collaboration with external partners. Use the STAR method (Situation, Task, Action, Result) to structure your responses effectively.
✨Be Ready for Technical Questions
Expect questions about technical lifecycle support and how you've handled change control or deviation investigations. Think of scenarios where you led a project or resolved a critical issue, and be ready to discuss the outcomes.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's MSAT strategy and how they collaborate with CMOs. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
