Technical Manager Sterile Products - Barcelona, España - Galderma

Galderma
Galderma
Empresa verificada
Barcelona, España

hace 1 semana

Isabel García

Publicado por:

Isabel García

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Descripción

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries.

We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology.

Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals.

Because we understand that the skin we're in shapes our lives, we are advancing dermatology for every skin story.

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 promote their personal growth 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 bold 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 an unparalleled, direct impact.


Further supporting our growth and innovation momentum, we are establishing a new Global Capability Center in Barcelona to deploy new capabilities to effectively support its global commercial and functional teams.

Located in the upscale Eixample District in the heart of Barcelona, Galderma's Global Capability Center offers numerous possibilities for professional development such as exposure to global and cross-functional projects and access to global career opportunities.


Job Description:


  • You will work on the management of a CDMO portfolio producing Pharmaceutical 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.
Key Responsibilities

  • Technical interface to external suppliers;


o Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s).

o Participate in routine meetings and lead problem solving activities using a range of lean sigma tools.

o Drive trouble-shooting activities and lean initiatives and workshop at suppliers to improve their manufacturing processes.

  • Launch & transfer for product(s) assigned:

o 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.)


o Track and report progress across projects by reviewing schedules and due dates, identifying risks and assisting teams with contingency plans.


  • Product/Technical Stewardship


o 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
o Review and contribute to process validation and risk management activities of the supplier.

o 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
o 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.

o Assess and process supplier and company changes, ensuring product impact is appropriately considered.

  • Manufacturing Excellence for defined product(s)
o Collaborate closely and effectively with cross-functional departments-Marketing, Quality, Regulatory, Procurement, and Manufacturing


Skills & Qualifications:

  • Degree in Engineering or Manufacturing, ideally in Life Sciences
  • Background 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
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