The company seeks a Senior Process Expert DP in Aubonne to lead technical activities for drug products, ensuring compliance, managing process improvements, and supporting new product introductions and technology transfers.
This position serves as the primary technical contact for drug product activities at the Aubonne site. The role is responsible for overseeing technical operations to maintain business continuity and manage product lifecycle tasks for existing products. The expert also coordinates new product introductions, technology transfers, and process validations, acting as the central point of contact for project stakeholders.
Responsibilities
- Oversee process enhancements for large-scale manufacturing across multiple product lines.
- Introduce new technologies and process analytical tools (PAT).
- Collaborate with site project managers and department heads to shape product strategies.
- Deliver project documentation, including strategy plans, protocols, and reports, according to schedules.
- Draft change control proposals for single or multi-site projects in coordination with management.
- Manage documentation and data using IT systems such as QMS software and ERP platforms.
- Maintain compliance standards for all process support activities.
- Review commercial product assessments and campaign reports.
- Lead major investigations alongside validation experts, production teams, and quality units.
- Identify manufacturing requirements and potential issues early in the process development and transfer phases.
- Deliver training on new process implementations, technology transfers, and technology strategies.
- Share expertise and innovations to expand the current platform knowledge base.
Requirements
- University degree in Biotechnology, Process Engineering, Pharmacy, or a related field.
- Background in drug product manufacturing.
- Over five years of experience in R&D or manufacturing settings.
- Proven ability to coordinate activities across teams.
- Experience with extractable and leachable studies, chemical compatibility, and filter validation.
- Strong understanding of the bio-pharmaceutical industry.
- Solid knowledge of GMP regulations and health authority expectations.
- Track record of successful process improvement initiatives.
- Experience working collaboratively with multiple departments.
- Ability to thrive in agile work environments.
- Fluency in both French and English.
What the company offers
- The company fosters an environment where every individual can access opportunities to develop and grow at their own pace.
- Employees join a culture focused on inclusion and belonging, empowering staff to contribute to human progress.
About the company
Merck (Schweiz) AG operates across six continents, bringing together diverse teams to innovate in healthcare, life science, and electronics. The organization develops medicines, intelligent devices, and technologies for areas like oncology, neurology, and fertility. Their workforce is driven by curiosity and a commitment to enriching lives, believing that varied perspectives fuel excellence and scientific leadership.
- Global teams collaborate with passion and curiosity to support patients throughout their lives.
- The healthcare division offers a diverse, inclusive, and flexible work environment.
- Employees come from varied backgrounds, which the company values as a driver of innovation.
- The organization is dedicated to caring for its people, customers, patients, and the planet.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.