Analytical Lead

Vor 5 Tagen

CorsiersurVevey, Schweiz Merck KGaA Darmstadt Germany Vollzeit

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Within CMC teams Lead the Global Analytical Development functionacting as a single point of contact for analytical tasks (development and GMP) from Early-Stage development, clinical trial supply, late phase development, commercial launch and commercialization of the molecule. Core team member in the Biotech CMC Development Program team representing the analytical functions, leading the respective "Analytical development core team" accountable for the management and execution of analytical development program's strategy.

In line with the whole CMC strategy, lead the "Analytical development core team", accountable for coordination of the analytical commitments integrating classic and innovative technologies. Accountable for ensuring the proper identification and availability of pre-requisites (e.g., appropriate planning, capacity, samples) needed for the analytical activities. Responsible for the identification of the most appropriate analytical solutions aimed to effectively support process development, clinical supply, scale-up, quality control as well as Regulatory expectations

**Key Responsibilities**:

- Represent Global Analytical Development acting as first point of contact for CMC team, CMC-PL and all relevant stakeholders. Ensure a timely and exhaustive communication flow among the parties so that project-related information is appropriately shared with functions for the achievement of the project goal.
- Ensure successful management of activities under the "analytical" area of responsibility and actively report the status (progresses, delays, risks) to the relevant Management level of GAD function and to the CMC-Team ensuring that the information is critically reviewed and appropriately presented.
- Facilitate the implementation of Analytical strategies designed and proposed by the "Analytical development core team", and relevant functional management(s), in alignment with planning and budget and in line with the overall CMC development strategy.
- Lead the "Analytical development Core Team", motivating and promoting collaboration among team members with the aim to effectively support the CMC Biotech program
- Ensure that all the required documentation (e.g., protocols, reports, certificates, releases), related to Analytical activities and needed for the program, is shared for review/approval with relevant stakeholders, timely approved and appropriately stored for consultation.
- Ensure that the proposed Analytical strategies are compliance to regulatory and health authorities' guidelines
- Ensure high level of performance on all Excellence Foundation levers (EHS, People, Quality, Service and reliability, Efficiency and Costs)

**Your Profile:
- Master's degree in Chemistry, Biology or Biochemistry or Engineering degree in Life Science / Biochemistry / Biology / Chemical discipline
- Demonstrated track record (at least 7 years) in Biopharmaceutical / Biotechnology industry or equivalent in the field of Analytical chemistry development for new biological entities (NBEs).
- Proven experience in Program Management of moderate to high complexity (at least, 5 years in program management; PMO or any other certification on Project management will be considered as an advantage
- Minimum 5 years of experience with proven track of project management. Official PMP certification or equivalent will be preferred.
- Budget workflows including all financial aspects of Opex and Capex monitoring
- Ability to empower and to be a result driven
- Be a Future-oriented and encourage collaborative teamwork

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your ow

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