Upstream Manufacturing Manager, Plasmid DNA

4 weeks ago

Magnolia, Texas, United States Asahi Kasei Full time
Job Description

The Asahi Kasei Group is committed to creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems.

As part of our business expansion plan, we are building a state-of-the-art facility that specializes in the development and manufacturing of Plasmid DNA. This facility will be equipped with cutting-edge technology and staffed by a team of highly skilled professionals who are dedicated to advancing the field of Plasmid DNA process development and manufacturing.

Job Responsibilities
  • Establish Plasmid DNA upstream GMP laboratories, including selecting equipment, setting up layouts and workflows, and ensuring alignment with industry standards and safety protocols.
  • Hands-on position responsible for executing plasmid DNA fermentation unit operations.
  • Recruit, train, and lead a team of scientists and associates responsible for upstream manufacturing activities. Provide guidance, mentorship, and performance feedback.
  • Facilitate the seamless transfer of developed processes to manufacturing teams, providing detailed documentation, training, and ongoing support.
  • Ensure all upstream manufacturing 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 Process Development, Quality Control, Quality Assurance, Program Management, and Business Development to ensure alignment of upstream manufacturing activities with overall company and client objectives.
  • Support investigations via equipment troubleshooting and testing to identify root causes.
  • Face-to-face interaction with clients to discuss laboratory capabilities and provide feedback.
  • Assist in generating Bill of Materials for plasmid DNA products.
  • Author technical documents such as equipment SOPs, work instructions and batch records.
  • Initiate and close downstream change controls, deviations and investigations.
  • Perform general laboratory duties associated with equipment maintenance and good housekeeping.
  • Keep abreast of industry trends, emerging technologies, and best practices in Plasmid DNA manufacturing to ensure the company remains competitive and innovative. Present or publish within the industry as appropriate.
Working Conditions
  • This position is required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.
Qualifications
  • 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 upstream processing (fermenters, centrifuges and tangential flow filtration (TFF) systems, single use technologies).
  • Experience with new laboratory start-up and equipment commissioning.
  • Hands-on experience in running manufacturing 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.
Benefits

Bionova offers 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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