At a Glance
- Tasks: Lead technical operations and ensure compliance in pharmaceutical manufacturing.
- Company: Join a leading global healthcare company committed to innovation.
- Benefits: Comprehensive benefits, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement and career advancement.
- Why this job: Make a real impact in drug development and improve patient lives.
- Qualifications: 7+ years in pharmaceutical operations and a relevant degree required.
The predicted salary is between 60000 - 80000 £ per year.
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.
- 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 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 Qualification
- 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.
Senior SME - MSAT EM Tech Ops DS DP in Ware employer: WISE Campaign
Contact Detail:
WISE Campaign Recruiting Team
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 trends in drug substance and product operations. We recommend practising common interview questions and scenarios that relate to your experience with CMOs and audits.
✨Tip Number 3
Showcase your continuous improvement skills! Be ready to discuss specific examples of how you've led change control or CAPA initiatives in past roles. This will demonstrate your value to potential employers.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search.
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 job description. Highlight your experience in drug substance and product technical operations, and don’t forget to mention any relevant certifications or training you have. We want to see how your background aligns 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 Senior SME role. Share specific examples of your experience with continuous improvement and technical investigations. We love a good story that showcases your skills!
Showcase Your Collaboration Skills: Since this role involves working with external manufacturing partners, make sure to highlight your collaboration experience. Talk about how you've successfully worked with CMOs in the past and any audits you've prepared for. We value teamwork and want to see how you can contribute!
Apply Through Our Website: 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 us you’re serious about joining our team at StudySmarter. We can’t wait to see your application!
How to prepare for a job interview at WISE Campaign
✨Know Your Technical Stuff
Make sure you brush up on your knowledge of drug substance and product technical operations. Be ready to discuss your experience with GMP compliance, analytical technologies, and any continuous improvement initiatives you've led. This role is all about technical expertise, so show them you know your stuff!
✨Prepare for Scenario Questions
Expect questions that ask you to describe how you've handled specific situations, like leading a technical investigation or managing change control. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your problem-solving skills.
✨Show Your Collaborative Spirit
This position involves working closely with external manufacturing partners, so be prepared to talk about your experience in collaboration. Share examples of how you've successfully worked with CMOs, especially during audits or technology transfers, to demonstrate your teamwork abilities.
✨Highlight Continuous Improvement Experience
Since continuous improvement is key in this role, come armed with examples of how you've identified areas for improvement and implemented changes. Whether it's through Lean, Six Sigma, or other methods, showing your proactive approach will set you apart from other candidates.