CMC Project Manager (m/f/d)

Permanent employee, Full-time · Planegg

Be part of our team

We are looking for a proactive and committed CMC Project Manager with experience in drug development located in the Germany area, who helps organize and plan CMC development and supply chain of our innovative ADC portfolio and to further develop the emerging pipeline of Tubulis. The CMC PM will play a critical role in ensuring that CMC projects and timelines align with Tubulis’ clinical programs, timelines, and budget constraints. The position requires a strong understanding of process development processes including late-stage regulatory requirements, project management methodologies, and effective communication skills. The PM will report to the SVP of CMC and work closely with the SVP of CMC, the CMC area leads as well as the Program Management, Finance and Clinical Operations teams.

Your mission

Manage CMC activities and supply chain for programs transitioning to GMP manufacturing and programs transitioning to late-stage development.
Develop comprehensive CMC project plans incorporating the scope, goals and timelines and aligning with overall program timelines.
Formulate and implement effective project strategies to ensure successful project outcomes.
Coordinate cross-functional project teams involving the internal team and our external partners (CMOs). Prepare timely agendas and document outcomes/next steps via meeting minutes. Follow through on open items.
Foster collaboration, provide guidance, support team members, address challenges, and promote a positive working environment.
Manage active CMC/GMP programs budget, track spend, conduct invoice reconciliation against work orders and ensure efficient resource allocation.
Maintain up to date project status reports to support SVP CMC and VP of Program Management.
Identify program and projects risks with CMC area leads and the Regulatory CMC lead and develop mitigation strategies and contingency plans. Ensure issues that may impact the project goals are pro-actively addressed.
Maintain effective communication channels with CMC team members, Program Management, Clinical Operations, Discovery, Finance and other CMC partners. Provide regular project updates highlighting progress and challenges.

Your profile

Master’s or advanced degree in chemistry, biotechnology or biochemistry. PMP certification is a strong plus.
8+ years of CMC experience in a pharmaceutical, biopharma, biotechnology, or related environment.
5+ years working in project management including late stage development programs.
Knowledge and experience in biopharmaceutical product lifecycle (e.g., pre-IND, Ph I-III, commercialization, lifecycle management), GMP requirements, CMC process development, FDA + EMA regulations and quality standards, drug development methodologies, and industry trends.
Proven leadership skills and ability to manage and motivate teams to achieve goals.
Excellent communication and presentation skills, and ability to interact with internal and external partners.
Ready to take on work beyond job description to meet critical deadlines and achieve goals.
Proficient in project management tools and software, e.g., MS Project, Excel, Power Point.
Ability to navigate and adapt to a dynamic and fast-paced work environment.
Fluent in English - written and spoken.
Proactive team player, striving to find best solutions in a collegial team environment.
Self-organized, self-motivated, and able to work independently.

Why us?

Flat hierarchies and short decision-making processes; open corporate culture; possibility of mobile working; unlimited contract after probationary period; 30 days' vacation; strong team spirit; personal appreciation of values; multicultural and global team and high level of collegiality; regular team events; mobility allowance; pleasant office atmosphere, modern technology standard.

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About us

The development of novel, effective and safe therapies for the treatment of cancer is one of the main challenges for modern medicine. We want to drive this process forward. The main goal of Tubulis is to become a leading company in the field of targeted therapeutics and antibody-drug conjugates (ADCs). With a strong team, our own technologies and innovative therapeutic concepts, we are ushering in a new era in the ongoing fight against cancer and share the vision of helping patients world-wide. Be part of a multidisciplinary and focused team, that works towards getting novel promising ADCs to patients with solid and hematological cancers.

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We’re excited to learn more about you!

We appreciate your interest in applying to Tubulis.

Please complete the short form below. If you experience any issues uploading your documents, feel free to contact us at career@tubulis.com.