Career Opportunities

Waisman Biomanufacturing strives to employ dedicated individuals who have a strong work ethic, are goal-oriented and take pride in accomplishments, have a collaborative approach to team-work, and excel in problem-solving in a deadline-oriented work environment.

Waisman Biomanufacturing offers a unique opportunity to be part of a team dedicated to the production of novel vaccines and therapeutics for human clinical trials across the United States and beyond. WB's wide range of projects and clients enables team members to broaden their skill sets, operate cutting edge equipment, and manage complex projects. WB is inspired and motivated through work to help patient populations suffering from diseases without cures. We are seeking highly motivated, independent yet team-oriented candidates with an enthusiastic and positive attitude, excellent multi-tasking skills and willingness to excel in a fast-paced, client-oriented, team environment.

Current Job Openings

Process Development and Manufacturing Manager

Job Summary:

The Process Development and Manufacturing Manager provides technical expertise, budget oversight, and/or staff supervision for client-based research programs to advance research. This position is responsible for developing and supporting manufacturing operations with any number of downstream and upstream processes (including but not limited to mRNA, lipid nanoparticle, plasmid DNA manufacturing), developing and executing Standard Operating Procedures (SOPs) for manufacturing operations, conducting equipment and process validation of manufacturing processes, performing manufacturing activities under cGMPs and completes project assignments as required to support all of these.

Key Job Responsibilities:

• Assists with the development and auditing of project-specific budgets

• Develops and executes manufacturing processes to produce scalable, repeatable methods to achieve required levels of quality and purity

• Oversees and manages client-specific projects and provides updates on project components and timelines to stakeholders

• Serves as a subject matter expert and unit liaison

• Completes manufacturing documentation, prepares reports, and presents findings to internal and external audiences

• Develops Standard Operating Procedures (SOPs) and Manufacturing Formulas (MFs)

• Oversees process development and current Good Manufacturing Practice (cGMP) manufacturing of biopharmaceuticals for use in various clinical trials

• Exercises supervisory authority, including hiring, transferring, suspending, promoting, managing conduct and performance, discharging, assigning, rewarding, disciplining, and/or approving hours worked of at least 2.0 full-time equivalent (FTE) employees

Required Qualifications:

Five years of experience in biopharma, drug substance or product, or RNA/LNP-based development and manufacturing is required. 

Preferred Qualifications:

• Expertise in one or more of the following: mRNA, vitro transcription, lipid nanoparticle formulation development, large scale microbial fermentation, chromatography, tangential and dead-end filtration, and aseptic processing.
• Expertise with automated equipment used in biologics manufacturing (e.g., liquid chromatography, TFF systems).
• Experience in process development and/or manufacturing of biotherapeutics for Phase I/II clinical trials in a cGMP environment.
• Working knowledge of current industry drug substance and drug product regulatory guidelines, CMC expectations, and regulatory filing contributions.
• Research and project management experience related to contract development and manufacturing projects.
• Experience and desire to work in a highly collaborative, team-focused environment.
• Experience as a supervisor is highly preferred.

Education:

A Bachelor’s Degree is required. A degree in Biochemical Engineering, Cellular Biology, Molecular Biology, Bacteriology, or a related field preferred.A Master’s Degree in the aforementioned fields plus five years of experience in biologics manufacturing is preferred.

Other

We're always looking for well-qualified candidates in process development and manufacturing, Quality Control, and Quality Assurance, so feel free to email your resume to careers@gmpbio.org as we may have a pending job opening to post.

Additional UW-Madison Employee Links:

Employment @ UW www.jobs.wisc.edu

Unless confidentiality is requested in writing, information regarding applicants must be released upon request. Finalists cannot be guaranteed confidentiality. UW-Madison is an equal opportunity/affirmative action employer.