Senior Downstream Manufacturing Specialist
4 weeks ago
We are seeking a highly skilled and experienced Senior Downstream Manufacturing Specialist to join our team at Asahi Kasei America Inc. This role will be responsible for leading downstream manufacturing activities, including establishing GMP laboratories, executing plasmid DNA purification unit operations, and recruiting, training, and leading a team of scientists and associates. The ideal candidate will have a strong background in downstream purification, experience with new laboratory start-up and equipment commissioning, and excellent leadership and communication skills.
Key Responsibilities:
- Establish and maintain GMP laboratories, including selecting equipment, setting up layouts and workflows, and ensuring alignment with industry standards and safety protocols.
- Execute plasmid DNA purification unit operations, including hands-on work with chromatography and tangential flow filtration systems.
- Recruit, train, and lead a team of scientists and associates responsible for downstream manufacturing activities.
- Facilitate the seamless transfer of developed processes to manufacturing teams, providing detailed documentation, training, and ongoing support.
- Ensure all downstream manufacturing activities adhere to applicable regulatory guidance and industry best practices.
- Collaborate with cross-functional teams and clients to ensure alignment of downstream manufacturing activities with overall company and client objectives.
- BS or MS in Biology, Chemical Engineering, Microbiology, Biochemistry or related field with 10+ years for BS and 7+ years for MS of relevant industry experience.
- 3-5 years of people leadership or managing people in direct reporting roles or in matrix organizations.
- In-depth understanding of downstream purification, including chromatography and tangential flow filtration systems.
- Experience with new laboratory start-up and equipment commissioning.
- Hands-on experience in running manufacturing processes.
- Strong leadership and communication skills.
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.
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