Senior Process Manager MSAT
vor 2 Wochen
About the Role:
Sobi seeks an experienced Process Manager to oversee the development and manufacturing of Drug Substance small molecule, non-sterile dosage forms for clinical and commercial use. The ideal candidate will have a strong scientific and technical background in CMC development and manufacturing, with expertise in solid and non-sterile dosage forms manufacturing.
Responsibilities:
- Process Owner: Responsible for the development and validation of Drug Substance small molecule, non-sterile dosage forms processes.
- Technical Expertise: Provide technical expertise in CMC development and manufacturing, with a focus on solid and non-sterile dosage forms.
- Regulatory Compliance: Ensure compliance with regulatory guidelines and authorities' communication.
- Project Management: Lead MSAT projects, including manufacturing process and cost improvement initiatives.
- Collaboration: Work closely with cross-functional teams to achieve project objectives.
Requirements:
- Education: University education in Chemistry, Pharmacy, or similar.
- Experience: +5-10 years of experience in development and manufacturing of Drug Substance small molecule, non-sterile dosage forms.
- Skills: Scientific and technical background in CMC development and manufacturing, expertise in solid and non-sterile dosage forms manufacturing, and experience in regulatory guidelines and authorities' communication.
- Language: Fluency in English.
About Sobi:
Sobi is a global biopharmaceutical company dedicated to rare diseases. We are committed to creating solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. Our culture conveys that our employees are our most valuable asset, and we offer a competitive benefits package to support the health and happiness of our staff.
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