Head of Cmc Development
vor 23 Stunden
**Position Snapshot**
Location: Lausanne, Switzerland
Company: Nestlé Health Science
Act. Rate: Full Time Act. Rate 100%
Type of contact: Permanent contract
**What we offer at Nestlé**
Flexible work policies in terms of core hours and working from home. Please talk to us during the recruitment process about what flexibility could look like for you
Genuine opportunities for career and personal development
Modern “smart office” locations providing agile & collaborative workspaces
Dynamic international working environment
Attractive additional benefits
**Position summary**
Nestlé Health Science is a globally recognized leader in the science of nutrition, with more than 11,000 employees around the world. With a portfolio of science-based consumer health, medical nutrition, vitamin and supplement brands, and pharmaceutical therapies, we are redefining the management of health.
Your main responsibility will be to oversee Pharmaceutical Product Development Department staffing, budgeting, planning and execution of drug product, analytics, and CMC strategies in a collaborative manner across internal disciplines and external partners and contractors.
We offer a dynamic, inclusive, and international working environment with many opportunities across different companies, functions, and regions. Don’t miss the opportunity to join us and work with different teams in an agile and diverse context.
**A day in the life of a Head of CMC Development**
Serve as the pharmaceutical development representative in R&D for internal and partnered project teams, assuring alignment of work scope to resources and budget
Lead budgeting and staff recruitment/ development to ensure a higher performing drug development function
Drive appropriate product formulations, manufacturing process, phase-appropriate product specifications
Ensure timeliness and continuity of clinical drug supplies with appropriate controls
Effectively manage contract manufacturing organizations (CMO) in line with internal and partner timelines and associated contract facilities.
Manage and develop a team of pharmaceutical development staff including Bulk Drug Substance, Drug Product and Analytical Development that is matrixed across multiple programs
Ensure GMP compliance to 21CFR part 211 and 820 (quality system regulations)
Work closely with QA, QC, Clinical supply, and regulatory and lead technical aspects of product/process investigations and development activities
**What will make you successful**
- MS/PhD degree in relevant field of science or engineering
- At least 15 years’ experience in pharmaceutical technical development disciplines
- At least 5 years of leadership experience at the department and/or larger team level, including recruiting/coaching high performing teams and creating/managing program budgets
- Extensive experience developing solid oral dosage forms, biologics and small molecules
- Expert at defining and leading cross-functional drug development functions from preclinical through phase 2/3: manufacturing, specifications, development studies, engineering, stability, shelf-life, etc
- Substantial experience managing technical development and cGMP manufacturing operations, including selection and oversight of CROs and CMOs
- Working knowledge of cGMP requirements and stage appropriate CMC regulatory requirements for pharmaceutical development and manufacturing
- A highly motivated self-starter with strong interpersonal skills including the use of influence and negotiations to successfully align and complete projects with both internal and external collaborators and “customers”
- Proven ability to manage and simultaneously advance multiple tasks and projects and “flex” between strategy and operational execution
- Skilled in clearly conveying complex concepts and study results in written and verbal form to a range of audiences including executive management and regulatory agencies
- Fluent in English
Nestlé Health Science is a leader in the science of nutrition, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Headquartered in Switzerland, we have more than 11,000 employees around the world, with products available in more than 140 countries.
Nutrition can be life-transforming for those who need extra support during short
- or long-term medical challenges, and it can enhance the quality of life of those who are already healthy. With an extensive research network providing the foundation for products that can help people to live their healthiest lives, our commitment to science-based products means that we provide nutritional solutions that can make a real difference in the quality of life of customers, patients, and caregivers.
At Nestlé, we want to help shape a better and healthier world, inspire people to live healthier lives and deliver impact at a scale and pace that makes a difference. We do this by
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