Director, Biologics Development

Vor 2 Tagen

Lausanne, Schweiz Nestle Vollzeit

Nestlé Health Science was created in 2011 by Nestlé, the leading food and beverage company. We are a unique health science company focused on advancing the role nutrition plays in changing the course of health for consumers, patients and healthcare professionals. Focused on delivering quality-of-life benefits through nutritional solutions, we harness scientific and clinical advances to improve health through managed nutrition. Behind our pioneering company are 3,000 people around the world who are driving breakthroughs and innovating for impact. With a global presence in about 50 markets, we invite you to impact the future of health and your career with us.

**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.

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 Director, Biologics Development**
- Develop and lead recombinant biologics (enzymes) and small molecules API/Drug Substance manufacturing operations at CMO sites to advance programs in clinical development
- Conduct gap analysis and propose innovative manufacturing process technologies and scale-up concepts to gain operational efficiencies
- Develop product requirements in collaboration with cross-functional teams
- Responsible for resolution of deviations, investigations, and process issues through analysis of historical data and other supporting studies
- Collaborate and work with Drug Product Development, analytical development/QC and QA teams to support manufacture, lot release, and stability evaluation in compliance with cGMPs
- Identify manufacturing process changes and process data requirements needed to progress to Phase 3 clinical studies and beyond
- Other responsibilities that may be assigned from time to time to progress enzymes or other programs
- Role of CMC Lead (API, Drug Product and Analytics) on some of the programs depending on needs
- Serve as the pharmaceutical development representative for internal and partnered project teams on API, assuring alignment of work scope to budget

**What will make you successful**
- BS/MS in relevant scientific or engineering discipline, PhD preferred
- A minimum of 12 years of biopharmaceutical industry experience including managing outsourced activities
- Experience developing biologics and small molecules
- Strong knowledge of GMP compliance, regulations and manufacturing operations especially as related to manufacture of biologics and small molecules
- Experience in cell line development, upstream processing, downstream processing is a must
- Strong working knowledge and interpretation of FDA/EU and ICH regulations and guidelines with direct experience in process development, scale-up and optimization
- Track record of consistently delivering results, having a bias for action, and translating strategy to implementation
- Strong verbal and written communication skills, with the ability to communicate effectively with others both within and external to the organization
- Effective decision making, demonstrating good judgment and constructive escalation
- Proactive in consistently anticipating and proposing solutions to potential problems before they arise
- A team player with a hands-on approach, able to quickly establish credibility, build rapport and trust and influence and maintain effective working relationships internally and externally
- Fluency 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 foun

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