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Team Leader Chemical Manufacturing Control Documentation
hace 3 meses
.Team Leader Chemical Manufacturing Control Documentation (CMC-D)YOUR TASKS & RESPONSABILITIESSupports the development of CMCD (Module 3 and QoS) strategy for Bayer's Consumer Health new and existing product pipeline and has life-time responsibility for all Bayer Consumer Health CMC Documentation.Brand Lead for Consumer Health Products.Manage CMCD Strategy for assigned brands for NPD and LCM projects.Author scientific briefing documents, complex TRDs, and responses to health authority questions; approve TRDs for NPDs.Conduct CMC-D assessments for business due diligence projects.Manage CMC-D change impact assessments.Author complex TRDs, and responses to health authority questions; approve TRDs for LCM projects.Lead category continuous improvement initiatives.Provide coaching and training to junior colleagues.Manage relevant functional processes.WHO YOU AREMaster's degree or higher, in a relevant scientific field (e.G., Chemistry, Biochemistry, Biotechnology), or international equivalent, with +4 years of proven hands-on experience (Analytical Development, Formulation Development, Manufacturing).Experience within Medicinal Regulatory-CMC is highly advantageous.Ph.D. degree, in a relevant scientific field (e.G., Chemistry, Biochemistry, Biotechnology), or international equivalent. Prior hands-on experience in a technical role within the pharmaceutical or related industry is preferred (Analytical Development, Formulation Development, Manufacturing).Strong understanding of product development processes.Knowledge/understanding of ICH. Knowledge of other quality systems guidelines is a plus.Knowledge/understanding of USP, Ph.Eur. and other relevant Pharmacopoeias.Familiarity with regulations, regulatory requirements and industry standards.Strong understanding of cGMP, principles of Quality Assurance and equivalent.Analytical and problem-solving abilities, with ability to prioritize and manage multiple projects simultaneously.Good communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.Proficient English communication skills, both written and verbal. Other languages are a plus.Detail-oriented with the ability to maintain accurate documentation and records.Ability to work independently and as part of a team in a fast-paced global environment.YOUR APPLICATIONThis is your opportunity to tackle the world's biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law
