CMC Leader Marketed Products

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

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.

Your role:CMC Leader in an established organization ofGlobal Biotech Manufacturing. You areresponsible for the CMC Management of Marketed Products of Endocrinology &Neurodegenerative Diseases. The elaboration, execution and maintenance of an integrated CMC roadmap is to be ensured under your leadership by a cross-functional team that oversees CMC activities. This includes activities regarding raw materials,DS/DP, formulation, manufacturing process, analytical methods,regulatory dossier and ensuring compliance. Essential consolidation of input from Business Franchise, Manufacturing, Regulatory Affairs and Quality to define short, medium and long-term CMC activities will be key. Ensure visibility to the CMC roadmap and major changes impacting CMC of Marketed Product. In addition, you communicate priorities and decisions concerning the CMC roadmap to relevant stakeholders. Youdrive the alignment with and get approval from Global Product Team. The successful product Life Cycle Management (LCM) requires your proactive leadership not only to identify and prioritize opportunities for process improvements/efficiencies with and end-to-end view on the product but to enable the LCM execution in the organization - adequate budgeting/resource allocation, strict adherence to set timelines and providing technical advice.

Who you are

• Master`s or Ph.D degree with minimum 7+ years of experience inbiologicsmanufacturing, qualityoperations, regulatory affairs or CMC development - preferably broad experience in manufacturing and one additional area
• Substantial experience in leading international cross-functional teams andproject management
• Good understanding of manufacturing, quality control, GMP and regulatory requirements.
• Profound knowledge of thebiotech business

What we offer:With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

Job Requisition ID: 226416

Location: Aubonne

Career Level: D - Professional (4-9 years)

Working time model: full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Job Segment:Neurology, Oncology, Biotech, Endocrinology, QC, Healthcare, Science, Quality