Technical Manager Sterile Products
hace 4 semanas
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.
**Job Description**:
Technical Manager Sterile Products
Barcelona, Spain
Core missions:
- You will work on the management of a CDMO portfolio producing Pharmaceutical or Cosmetic products for worldwide markets.- The MS&T Technical Manager acts as key interface between Galderma and the external suppliers to resolve technical challenges, oversee validation activities and evaluate technical changes.- The position holder is the major contributor to all manufacturing related questions and topics.
Description of the responsibilities:
Technical interface to external suppliers:- Participate in routine meetings and lead problem solving activities using a range of lean sigma tools.- Drive trouble-shooting activities and lean initiatives and workshop at suppliers to improve their manufacturing processes.
Launch & transfer for product(s) assigned- Technical Transfer Lead Responsible for technology transfer activities at site level (within, inbound and outbound), including any scale-up or other process adaptations. Leads technical transfer project team at site and liaises efficiently with involved functions (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites.)- Track and report progress across projects by reviewing schedules and due dates, identifying risks and assisting teams with contingency plans.
Product/Technical Stewardship- Lead process validation activities at CMO site together with our partners, support root cause investigation of product and process deviations and leads process improvements (either cost/yield and/or product quality) together with key internal and external stakeholders.
Validation for product(s) in scope- Review and contribute to process validation and risk management activities of the supplier.- Ownership and drive of technical changes, assess the impact of technical changes and technical feasibility of proposed changes. Alignment of changes with internal stakeholders.
Interface to Development for the product(s) assigned- Assess manufacturing capability & capacity as part of new supplier selection or existing supplier gap analysis activity. Ensure technical excellence in operational start-up for new manufacturing equipment and areas.- Assess and process supplier and company changes, ensuring product impact is appropriately considered.
Manufacturing Excellence for defined product(s)-
- Collaborate closely and effectively with cross-functional departments-Marketing, Quality, Regulatory, Procurement, and Manufacturing
**Requirements**:
- Degree in Engineering or Manufacturing, ideally in Life Sciences- Minimum of 5 years’ experience in the pharmaceutical, biopharmaceutical or medical device industry in a manufacturing / engineering role- Thorough knowledge of GMP / GDP- Project Management experience- Experience with sterile products and aseptic filling- A formal qualification in continuous improvement qualification is preferred- English fluent - any other language would be a plus- Agile and ready to travel internationally (25%)
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