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For Companies 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, career development, and a supportive work environment.
- Other info: Opportunity to collaborate with global teams and enhance your skills.
- Why this job: Make a real impact in drug development and improve patient lives.
- Qualifications: Bachelor's degree in a scientific field and 7+ years of relevant experience.
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 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
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work with CMOs. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge and recent trends in drug substance and product operations. We want you to showcase your expertise and how you can contribute to continuous improvement in the role.
✨Tip Number 3
Don’t forget to highlight your experience with audits and inspections during interviews. We know how crucial it is to be inspection-ready, so share your success stories and how you've supported teams through these processes.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and eager to join our team.
We think you need these skills to ace Senior SME - MSAT EM Tech Ops DS DP
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the job description. Highlight your 7+ years in drug substance or product operations, and don’t forget to mention any relevant certifications or training!
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 technical operations and continuous improvement.
Showcase Your Achievements: When detailing your experience, focus on your achievements. Did you lead a successful technology transfer? Mention it! Quantify your successes where possible to make a stronger impact.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the info you need about the role and our company!
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 will show that you’re not just familiar with the basics but can also contribute to the technical strategy.
✨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. This will help you articulate your experience clearly and effectively.
✨Show Your Collaborative Spirit
Since the role involves working with external manufacturing partners, be prepared to share examples of successful collaborations. Talk about how you’ve coached teams or developed technical capabilities across different sites. Highlighting your teamwork skills will demonstrate that you can thrive in a multi-site environment.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the company and the role. Inquire about their current challenges in technical operations or how they approach continuous improvement. This not only shows your enthusiasm but also gives you valuable insights into the company culture.