Manager, Downstream Manufacturing, Plasmid DNA

Bionova Scientific Llc

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products. 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. 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 challenges.

Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.

Position Summary:

This role presents a unique opportunity to establish the foundation and set direction for the facility currently being designed and constructed. The role will be responsible for leading downstream manufacturing activities, staffing the functional area, and building the infrastructure to enable on-time and within budget execution and completion of future client projects. Partnering closely with cross-functional representatives and clients, this role will ensure Plasmid DNA manufacturing activities are completed per agreed upon timelines and deliverables.

Essential Duties and Responsibilities:

• Establish Plasmid DNA downstream 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 purification unit operations.
• Recruit, train, and lead a team of scientists and associates responsible for downstream 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 downstream 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 downstream 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 downstream purification (chromatography and tangential flow filtration (TFF) systems, single use technologies) with expertise in AKTA purification systems and Unicorn programming.
• 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.

Health Benefits and Program: 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.

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.