Cell Therapy Manufacturing Subject Matter Expert
Waisman Biomanufacturing offers a unique opportunity to be part of a team dedicated to the production of novel therapeutics for human clinical trials across the US and beyond. Our wide range of projects and clients enable team members to broaden their skill sets, operate cutting edge equipment, and manage complex projects. We are inspired and motivated through work to help patient populations suffering from diseases without cures. Read more about the specific requirements for this opening on the Upstream Biomanufacturing Cell Therapies team and apply to join our dynamic group.
The Researcher will serve as a Subject Matter Expert (SME) and will provide technical expertise in the areas of cell therapies and large scale cell culture. This includes designing, developing and executing cell culture and upstream manufacturing processes to support the production of clinical trial materials for WB and its clients and new project-specific process development, assay development and manufacturing processes for the scale-up and manufacturing of biotherapeutics. A Master's degree or PhD in Cellular Biology, Microbiology, Molecular Biology, Biochemical Engineering or a related field is highly preferred. Persons with a Bachelor's Degree in the aforementioned fields and a minimum of 10 years of relevant work experience will be considered.
Well-qualified applicants will have the following preferred experience and knowledge:
- 2+ years of experience in process development and/or manufacturing of biotherapeutics for Phase I/II clinical trials. Previous work experience in the biotechnology industry is highly preferred.
- Expertise in one or more of the following areas: large scale mammalian cell culture, viral vector production, bioreactors, or cell therapies (hESC, iPSC, MSC).
- Experience with assay development related to cell therapies.
- Expertise in flow cytometry, qPCR, CliniMACS selection and tangential flow filtration.
- Experience and desire to work in a highly collaborative, team-focused environment.
- Expertise in development, validation, execution, monitoring and manufacturing of novel biotherapeutics, vaccines, and related components as well as manufacturing operations as required.
- Expertise in cGMPs and application to the process development and manufacturing of biotherapeutics or vaccines.
- Research and project leadership experience related to the production of biopharmaceuticals.
Principal duties:
Research, Process Development, and Manufacturing Operations (75%):
- Research, design, develop and execute new project-specific process development, assay development, and manufacturing processes for the scale-up and manufacturing of biotherapeutics.
- Serve as the Subject Matter Expert (SME) and provide technical research expertise in the areas of upstream process and cell therapies.
- Evaluate the upstream process development needs of new and existing biotherapeutic and vaccine projects in collaboration with clients, WB director, and the manufacturing team.
- Address technical difficulties with cell culture and bioreactor operations. Collaborate internally and externally to find solutions to complex problems.
- Develop and revise manufacturing SOPs (Standard Operating Procedures), specifications for raw materials and finished products in collaboration with investigators and potential clients.
- Participate in clinical manufacturing campaigns for client projects as needed.
- Assist with investigating and evaluating state-of-the-art equipment for manufacturing and monitoring processes.
- Develop equipment specifications based on plans for WB clinical research projects and input from investigators and clients.
- Provide training and mentoring to staff and actively share knowledge with the WB team.
Project Management and Supervision of Staff (10%):
- Plan and execute client projects. Coordinate and manage assigned project components and timelines.
- Effectively manage available resources, coordinate workload and communicate with clients, cross- functional teams and management in order to facilitate smooth and timely execution and completion of projects.
- Analyze results, prepare reports and present findings to staff and clients.
Equipment/Process Validation (5%):
- In conjunction with the Manager of Operations and manufacturing staff, prepare and execute Performance Qualifications (PQs) protocols.
- Summarize and write reports for process development and related validation studies.
Internal and External Relations (5%):
- Consult and collaborate with UW-Madison research/clinical investigators and corporate collaborators to investigate and research potential solutions to all process development and manufacturing issues.
- Assist WB Director, staff, investigators and clients in preparing documentation for IND filings, including preparation of Chemistry, Manufacturing, and Control (CMC) sections.
- Support the WB Director in liaison responsibilities with corporate collaborators and other federal, state or private entities that visit, inspect, audit or utilize WB.
- Interact with the UW Safety Office, BioSafety Office and the Office of Risk Management in the review of manufacturing protocols and facility safety program as needed.
Seminars, Trainings and Proposals (5%):
- Provide input and technical expertise on grant or other proposal submissions as requested.
- Maintain awareness of current literature as it pertains to WB's focus and attend relevant conferences and workshops.
- Maintain and analyze data for proposals and presentations.
To find out more and to apply by March 30th, please visit: https://jobs.hr.wisc.edu/en-us/job/504765/cell-therapy-manufacturing-subject-matter-expert