Manager, Downstream Manufacturing, Plasmid DNA

Asahi Kasei•The Woodlands, TX

About The Position

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.

Requirements

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.
Strong attention to detail.
Effective verbal and written communication skills.

Nice To Haves

Proven client interactions and project management experience desired.

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.