CMC-D Manager (all genders)

CMC-D Manager (all genders)

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.

Your Tasks and Responsibilities

• Act as the Brand Lead for herbal Consumer Health Products.
• Manage the CMC‑D strategy for assigned brands for both NPD and LCM projects based on specific herbal regulatory requirements.
• Author scientific briefing documents, complex TRDs, and responses to health authority questions, and approve TRDs for NPDs.
• Conduct CMC‑D assessments for business due diligence projects.
• Manage CMC‑D change impact assessments.
• Lead category continuous improvement initiatives while providing coaching and training to junior colleagues.
• Manage relevant functional processes.
• Experience in phyto-specific regulatory requirements for Module 3 preparation is highly desirable, with additional experience or knowledge of chemical products a plus.

Who You Are

• Hold a Bachelor's, Master's, or Ph.D. degree in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or an international equivalent, supported by hands‑on experience in a technical role within the pharmaceutical or related industry (e.g., Analytical Development, Formulation Development, Manufacturing).
• Strong understanding of product development processes.
• Knowledge and understanding of ICH; familiarity with other quality‑system guidelines is a plus.
• Familiarity with USP, Ph. Eur., and other relevant Pharmacopoeias.
• Understanding of regulations, regulatory requirements, and industry standards.
• Strong understanding of cGMP, Quality Assurance principles, and equivalent frameworks.
• Strong analytical and problem‑solving abilities and can prioritize and manage multiple projects simultaneously.
• Effective communication and collaboration with cross‑functional teams and stakeholders.
• Detail-oriented, maintain accurate documentation and records, and work effectively both independently and as part of a team in a fast-paced global environment.
• Proficient English communication skills, both written and verbal; additional languages are a plus.

What We Offer

Our benefits package is flexible, appreciative, and tailored to your lifestyle, because: What matters to you, matters to us!

• Financial stability: Competitive compensation package, attractive base pay, annual bonus, and potential for individual performance awards.
• Flexibility: Hybrid work models and part-time arrangements available when possible.
• Family support: Company daycare centers, childcare assistance, time off for family care, children's summer camps, and more.
• Professional growth: Access to learning and development opportunities, training programs through the Bayer Learning Academy, development dialogues, coaching, and mentoring programs.
• Health awareness: Measures for self-care, including free health checks with the company doctor.
• Inclusivity: An inclusive work environment where you are welcomed, supported, and encouraged to bring your whole self to work.

Be You. Be Bayer.

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 national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, orientation, gender identity, gender expression or any criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Location: Germany: Hessen: Darmstadt Division: Consumer Health Reference Code: 861288

Arbeitsorte

• 64295 Darmstadt

Remote Model: Hybrid