Scientist I, Downstream Process Development
4 weeks ago
We are seeking a highly motivated and experienced Scientist I, Downstream to join our team at Asahi Kasei America Inc. This role will play a critical part in the development and execution of purification processes and technology transfer projects.
Job Summary:The Scientist I, Downstream will be responsible for executing complex unit operations, including solution prep, harvest operations, tangential flow filtration, chromatography, product filling, and operation of single-use purification systems. This role will also involve authoring and reviewing technical documents, performing internal support activities, and maintaining cleanroom standards.
Key Responsibilities:- Execute complex unit operations, including solution prep, harvest operations, tangential flow filtration, chromatography, product filling, and operation of single-use purification systems.
- Author and review technical documents, including tech transfer protocols and development reports, experimental plans, batch records, training materials, and SOPs.
- Perform internal support activities, including maintenance of processing equipment, stocking of consumables, discarding expired reagents, material coordination, and weigh and dispense.
- Maintain cleanroom standards, practices, and housekeeping according to SOPs.
- Recognize and address minor issues from equipment and affiliated documentation, notify managers and leads of issues and discrepancies immediately, and assess impact of issues and non-conformities to products and projects.
- BS or MS in Engineering, Life Sciences, or related discipline with 5-8 years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
- Must have TFF and chromatography operations experience.
- In-depth understanding of purification unit operations is required.
- Hands-on experience in running and developing processes.
- Experience in process development, process characterization, and/or technology transfer processes.
- Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing.
- Creative thinker that can identify better and more efficient methods to address issues and gaps.
- Demonstrate ability to work independently and on cross-functional teams.
- Ability to handle more than one task at a time, while maintaining attention to detail and working in a fast-paced environment.
- Strong analytical skills and attention to detail.
- Effective verbal and written communication skills.
- Must be able to work independently as well as work with a diverse team.
- Must have the ability to work efficiently in a fast-paced environment.
- Flexibility with work hours to meet business needs, including weekends and holidays, as needed.
- Health benefits at a subsidized rate.
- Healthcare, Dental, and Vision insurance.
- Life Insurance and Disability Program: 100% covered by Bionova.
- Retirement Plan (401K) Up to 8% of Employer Match.
- Paid time off up to two weeks.
- 10 days of Holidays and 5 days of Sick Leave.
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