Sobre o nosso cliente
Multinational Pharmaceutical Company.
Descrição
- Lead co-development activities with external partners, ensuring product transition to commercial manufacturing and collaborating with internal teams for seamless product integration;
- Develop and improve analytical methods for products, following international standards and regulatory expectations, up to validation;
- Support technology transfer of registered products between manufacturing sites and partners;
- Work with various oral dosage forms, with additional knowledge of other pharmaceutical dosage forms being a plus;
- Implement and draft validation procedures and documentation, in collaboration with manufacturing, regulatory, and quality teams;
- Provide technical support for registration and submissions, including resolving deficiencies until approval;
- Troubleshoot and recommend modifications to formulas and processes to improve productivity, quality, and cost;
- Ensure quality and compliance in R&D activities, safeguarding intellectual property and driving continuous process improvement;
- Oversee knowledge and process transfer between R&D teams, accelerating time-to-market for products;
- Manage the technology transfer lifecycle, including planning, execution, and monitoring;
- Supervise equipment selection, sizing calculations, and P&ID development based on client requirements;
- Prepare operational documentation (e.g., batch records, SOPs) and support capacity planning activities.
Perfil ideal
- University degree, preferably in Pharmacy, Chemistry or Engineering;
- Strong project management skills and process development or technology transfer skills with 3 years of current work experience;
- A minimum of 5 years of experience in the pharmaceutical industry, with a strong background in research and development;
- Proven expertise in technical transfer processes, ensuring the transition of knowledge and processes;
- Experience executing projects in a GMP-regulated environment is considered a strong asset;
- Management of projects, systems, clients, and business relationships;
- Excellent collaboration and communication skills to work effectively with cross-functional teams;
- Proficiency in written and spoken English with the ability to communicate clearly with clients.
Vantagens
A collaborative and friendly environment.