Project Manager External CMC Development (m/f/d) at Bayer AG - Venezuela

Ratingen, North Rhine-Westphalia, Germany -

Full Time

Start Date

Immediate

Expiry Date

27 May, 26

Salary

0.0

Posted On

26 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Scientific Leadership, Process Development, API Development, Scale Up, Chemical Consultancy, Troubleshooting, Control Strategies, Project Management, Alliance Management, Regulatory Compliance, CMC Assessment, Synthetic Chemistry, Process Optimization, COGS Calculation, Supply Chain Management, Cross-functional Teamwork

Industry

Chemical Manufacturing

Description

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. Project Manager External CMC Development (m/f/d) We are seeking an experienced Chemical Process Research & Development expert to join our team as Project Manager External CMC Development. In this role, you will play a key role in the design, development, and optimization of manufacturing processes for new chemical entities. You will lead chemical process R&D activities and ensure API development and supply for preclinical and clinical-stage projects in close collaboration with our external partners (CDMOs). As part of the CMC & Technology organization, you will act as a critical interface between internal R&D teams and external suppliers, ensuring that API development and supply are fast, safe, cost‑efficient, timely, and fully compliant with quality and regulatory standards. Your strong chemical expertise and extensive experience within the pharmaceutical industry will be essential in defining drug substance development strategies, providing expert chemical consultancy, and driving pragmatic, rapid solutions to technical challenges across our internal and external manufacturing network. YOUR TASKS AND RESPONSIBILITIES Scientific leadership and coordination for the development and optimization of production processes for new Active Pharmaceutical Ingredients (APIs). Perform assessment of chemical routes, CMC packages, COGS calculation and manufacturing & supply concepts. Ensure smooth implementation of processes in manufacturing plants ("scale up") Provide chemical expertise, consultancy, and propose quick solutions in troubleshooting within the internal and external manufacturing network Support development of concise control strategies for IND/IMPD filings Manage complex projects at suppliers with a high degree of independence Collaborate closely in and/or manage interdisciplinary project teams. Ensure appropriate alliance management in our network of external partners. Ensure compliance with external and internal rules and regulations for assigned supplier activities. Navigate within an interdisciplinary community of External CMC managers, project leads, the API network group as well as a network of project teams Support CMC assessment of in-licensing opportunities WHO YOU ARE Ph.D. in Chemistry Strong background in synthetic chemistry and chemical process development Experiences with peptides would be an advantage Several years of experience in the pharmaceutical industry in Chemical Process Research & Development and optimization of API production processes, incl. understanding of regulatory requirements and quality standards Experience in managing external partners or working at a CDMOs Strong communication and project management skills High assertiveness, service orientation and enjoy working in a cross-functional team High ability to solve problems and to structure and simplify complex tasks Ability to effectively challenge the status quo and underlying assumptions to uncover fresh innovations and drive ideas into results Fluency in English, fluency in German would be an asset, willingness to learn German mandatory WHY BAYER? Our benefits package is flexible, appreciative, and tailored to your lifestyle, because: What matters to you, matters to us! We ensure your financial stability through a competitive compensation package, consisting of an attractive base pay and our annual bonus. Whether it’s hybrid work models or part-time arrangements: Whenever it is possible, you will have the flexibility to work how, when and where it is best for you. Your family is a top priority. We offer loving company daycare centers at multiple locations, support in finding childcare, time off for the care of elderly or dependent family members, summer camps for children, and much more. We support your professional growth by providing access to learning and development opportunities, training programs through the Bayer Learning Academy, development dialogues, as well as coaching and mentoring programs. We promote health awareness and opportunities for selfcare through various measures, such as free health checks with the company doctor and our health platform #machtfit. We embrace diversity by providing an inclusive work environment in which you are welcomed, supported, and encouraged to bring your whole self to work. Ever feel burnt out by bureaucracy? Us too. That’s why we’re changing the way we work - for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https://www.bayer.com/en/strategy/strategy #LI-DE YOUR APPLICATION This 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. We are committed to treating all applicants fairly and avoiding discrimination. Location: Germany : North Rhine Westfalia : Wuppertal-Elberfeld Division: Pharmaceuticals Reference Code: 860529

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Responsibilities

The role involves providing scientific leadership and coordination for the development and optimization of production processes for new Active Pharmaceutical Ingredients (APIs), including assessing chemical routes and manufacturing concepts. This person will also act as a critical interface, ensuring API development and supply from external partners are fast, safe, cost-efficient, and compliant.