Formulation & Process Development Manager
vor 6 Monaten
**Position Snapshot**
Location: Nestlé Health Science Lausanne, Switzerland or East Coast, USA
Company: Nestlé Health Science International
Act. Rate: Full-Time Act. Rate 100%
Type of contract: 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.
The Formulation & Process Development Manager will assist in the development of oral dose formulations and manufacturing processes for pipeline products, including small molecules and biologics. They will play a key role in leading drug product development activities at contract development and manufacturing organizations (CDMOs) to ensure the delivery of preclinical and clinical drug product batches that meet program requirements.
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 Formulation & Process Development Manager**
- Assist in implementing phase-appropriate formulation and process development at external CDMOs.
- Follow FDA guidance and QbD principles for registration batch manufacturing and validation activities.
- Ensure on-time delivery of clinical trial materials (CTM) in accordance with documented work plans and cGMP requirements.
- Oversee batch manufacturing, intermediate sampling, and finished product characterization.
- Establish control strategies for critical raw material attributes and in-process controls.
- Coordinate with Analytical Function for testing of new drug products and initiating stability studies.
- Collaborate with Quality Assurance and Regulatory Affairs for cGMP compliance and drafting regulatory submissions.
- Communicate effectively across multiple business functions and build relationships with internal and external partners.
- Participate in GMP investigations and develop corrective action plans.
- Exhibit scientific curiosity and contribute to relevant technical areas, such as drug substance process development.
**What will make you successful**
- Ph.D. with 3+ years or M.S. with 5+ years of experience in the Pharmaceutical or Biotech industry
- Education in Pharmaceutics, Chemical Engineering, Bioengineering, Pharmaceutical Chemistry, or related scientific disciplines preferred.
- Hands-on experience in developing and scaling up formulations for oral solid dosage forms and parenteral formulations.
- Experience in developing immediate, modified, and controlled release formulations for solid dosage forms and bioenhanced formulations.
- Proficiency in drug product physiochemical and mechanical characterization, and drug-excipient compatibility study.
- Familiarity with Quality by Design (QbD) concepts and design of experiments (DoE).
- Ability to work effectively with external CDMOs to meet timelines and budgets.
- Experience in drafting relevant sections of INDs and NDAs.
- Ability to work independently in a team environment with various internal departments.
- Willingness to travel up to 25% of the time.
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 fostering a diverse, friendly, supportive, and collaborative environment, that creates positive disruption, embraces innovation, and empowers people and teams to win. We aim to hire friendly, respectful,
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