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CMO Technical Advisor Manager
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MISSION
Provide technical assessment and guidance for activities carried out at CMOs related to product development, analytical transfers, and process transfers. Monitor execution of these activities and act as a technical advisor for issue resolution when needed, ensuring alignment with the objectives of Pharmaceutical Industrial Development.
MAIN RESPONSIBILITIES
1. Development and Transfers
Monitor and technically support product development activities at CDMOs.
Oversee and technical guidance on analytical methods and product transfers when CMOs are involved.
2. Technical Assessment & Issue Resolution
Support the External Sites Operations team in technical evaluations and feasibility assessment.
Provide technical assistance to CMOs in and assessing and resolving incidents when necessary.
3. Regulatory & Documentation Support
Contribute to drafting and reviewing regulatory documentation needed for new registrations and variations, from an industrial pharmaceutical development viewpoint.
4. Continuous Improvement
Actively participate in Continuous Improvement and Innovation initiatives, identifying improvement opportunities and promoting innovation.
Contribute to the Industrial Area's strategic goals and challenges.
REQUIRED EDUCATION AND EXPERIENCE
Bachelor's and Master's degree in Pharmacy, Chemistry, or related field.
More than 3 years' experience in pharmaceutical manufacturing and/or pharmaceutical development activities.
PREFERRED SKILLS & COMPETENCES
- Knowledge of biopharmaceutical products and their specific manufacturing and analytical requirements.
Excellent understanding of GMP regulations, with the capability to assess technical data, manage deviations, and evaluate risks effectively.
Knowledge of Lean Continuous Improvement tools.
Good verbal and written communication skills to effectively interact with CMOs, and internal stakeholders.
High level of accountability, autonomy to operate independently, and proactively seek support when needed.
Strong ability to analyze situations, extract critical information, and assess impacts on business decisions.
Capacity to evaluate risks, critical analysis, and comparison of alternative solutions.
Fluency in English. Fluency in Spanish will be highly desirable.
Ability to use IT tools for documentation, data handling, and project tracking.
Why work with Almirall?
We are a people-centric company where employees are at their best, patients and customer are at the heart of every decision, and our focus and agility allow us to deliver greater impact for all.
Additionally, for the 17th year in a row, we have been certified as Top Employer Spain, and also Top Employer Germany for the first time.
This strengthens our commitment to create a unique work environment that helps our employees to develop their skills to fullest and grow both professionally and as individuals.
We are delighted to have a great team that is proactive, innovative, and eager to transform the world of people with skin conditions.
We are proud of each one of our employees, their development, and growth: they are the success of the company.
Our purpose
"Transform the patients' world by helping them realize their hopes & dreams for a healthy life".
Our values
Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
Courage: we challenge the status quo, we take full ownership and we learn from our success & failures.
Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.
At Almirall, it's all about people!
#wearealmirall
Candidatura gestionada por Almirall