Asahi Kasei Bioprocess America, Inc. ยท 1 month ago
Manager, Upstream Process Development, Plasmid DNA
The Woodlands, TX
Full-time
Onsite
Senior Level
7+ years expAsahi Kasei Bioprocess America, Inc. is committed to creating for tomorrow and operates in various business sectors. The Manager, Upstream Process Development will lead upstream process development activities and establish the foundation for a new facility focused on Plasmid DNA, ensuring projects are completed on time and within budget.
BiotechnologyManufacturing
Responsibilities
Establish Plasmid DNA upstream laboratories, including selecting equipment, setting up layouts and workflows, and ensuring alignment with industry standards and safety protocols
Recruit, train, and lead a team of scientists and associates responsible for upstream development activities. Provide guidance, mentorship, and performance feedback
Lead the development efforts to optimize upstream capability. This involves designing experiments, analyzing data, and making recommendations for improvements
Lead a team of scientists to design, develop and implement development and optimization work for both internal and external client projects
Facilitate the seamless transfer of developed processes to manufacturing teams, providing detailed documentation, training, and ongoing support
Ensure all upstream development activities adhere to applicable regulatory guidance and industry best practices. Compile and/or support the creation of documentation for regulatory submissions
Collaborate with cross-functional teams and clients, including Manufacturing, Quality Control, Quality Assurance, Program Management, and Business Development to ensure alignment of upstream development activities with overall company and client objectives
Support investigations via equipment troubleshooting and testing to identify root causes
Prepare and present concise, sound scientific presentations of study results to the internal and external team for decision making
Face-to-face interaction with clients to discuss laboratory capabilities and provide feedback
Author technical documents such as laboratory and equipment SOPs (Standard Operating Procedures), batch records, process development reports, and transfer protocols/reports
Evaluate new technologies and innovations to improve operational efficiency or expand upstream development capabilities
Perform general laboratory duties associated with equipment maintenance and good housekeeping
Keep abreast of industry trends, emerging technologies, and best practices in Plasmid DNA development to ensure the company remains competitive and innovative. Present or publish within the industry as appropriate
Qualification
Required
BS, MS or PhD in Biology, Chemical Engineering, Microbiology or Biochemistry with 10+ years for BS, 7+ years for MS and 5+ year for PhD of relevant research and/or industry experience
3-5 years of people leadership or managing people in direct reporting roles or in matrix organizations
In-depth understanding of upstream and upstream process development (upstream controllers, tangential flow filtration (TFF) systems, centrifugation, cell lysis and single use technologies)
Experience with new laboratory start-up and equipment commissioning
Hands-on experience in running and developing upstream processes
Creative thinker that can identify and efficiently improve processes to address issues and gaps
Demonstrate ability to work independently and on cross-functional teams
Proven client interactions and project management experience desired
Strong attention to detail
Effective verbal and written communication skills
Company
Asahi Kasei Bioprocess America, Inc.
As a global partner to the biopharmaceutical industry, Asahi Kasei Bioprocess helps biologics manufacturers safely and efficiently produce medicines that patients can trust, by dependably supplying innovative yet exceptionally reliable bioprocess consumables, equipment and scientific support services.
51-200 employees
H1B Sponsorship
Asahi Kasei Bioprocess America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (1)
2022 (2)
2021 (2)
Funding
Current Stage
Growth StageLeadership Team
Daniel Strauss
Director of R&D
Recent News
GlobeNewswire News Room
2025-02-25
2025-02-18
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