Process Development and Manufacturing Manager

University of Wisconsin Madison; Madison (WI); On-site; USD 81,000 - 99,000; Full time

Benefits offered by this job

Generous vacation/holidays/PTO

Retirement benefits

Comprehensive health ins and insurance

Job summary

University of Wisconsin–Madison seeks a Process Development and Manufacturing Manager to lead biomanufacturing operations for Phase I/II clinical trials within the WB facility. You will develop and validate upstream/downstream processes, create SOPs, and ensure cGMP compliance across projects.

Collaboration with cross-functional teams is essential, with after-hours/rotating weekend duties. The role requires a Bachelor's degree (Master's preferred) in Biochemical Engineering or related field and

Qualifications

• Five years of experience in biopharma, drug substance or product, or RNA/LNP-based development and manufacturing.
• Master's degree preferred in Biochemical Engineering, Cellular Biology, Molecular Biology, Bacteriology, or related field.
• Experience supervising staff is highly preferred.
• Knowledge of cGMP manufacturing for Phase I/II clinical trials.

Responsibilities

• Develops and executes manufacturing processes to produce scalable, repeatable methods ensuring quality and purity.
• Oversees client-specific projects and communicates timelines to stakeholders.
• Develops SOPs and Manufacturing Formulas; completes manufacturing documentation and reports.
• Supervises 2.0 FTE employees and manages performance and hours.

Skills

Biopharma experience

cGMP knowledge

Leadership

Project management

Regulatory understanding

Education

Bachelor's Degree

Master's Degree in Biochemical Eng

Tools

Liquid chromatography

TFF systems

Aseptic processing

Job description

Current Employees: If you are currently employed at any of the Universities of Wisconsin, log in to Workday to apply through the internal application process.

Job Category: Academic Staff

Employment Type: Regular

Job Profile: Process Development and Manufacturing Manager

The Waisman Center is dedicated to the advancement of knowledge about human development, developmental disabilities, and neurodegenerative diseases throughout the lifespan. One of 15 centers of its kind in the United States, the Waisman Center encompasses laboratories for biomedical and behavioral research, several scientific research cores, and a clinical biomanufacturing facility for the production of pharmaceuticals for early stage human clinical trials. In addition to its research efforts, the Center provides an array of services to people with developmental disabilities, offers numerous educational and outreach programs to young children and their families, and trains scientists and clinicians who will serve our nation in the future.

This position will work within the Waisman Biomanufacturing (WB) work unit. WB is a clinical manufacturing facility that produces biologics (gene therapeutics, cell therapeutics, recombinant proteins and vaccines) for Phase I and II Human Clinical Trials in compliance with current Good Manufacturing Practice (cGMP) guidelines.

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.

After hours and weekend response to facilities and equipment alarms as well as weekend LN2 tank exchange is required on a rotating basis.

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

Department:

Waisman Center

Compensation:

$89,725; Salary is negotiable and will be based on education, experience and skills.

• Employees in this position can expect to receive benefits such as generous vacation, holidays, and paid time off; competitive insurances and savings accounts and retirement benefits.

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.

Additional Information:

• The successful applicant will be responsible for ensuring eligibility for employment in the United States on or before the effective date of the appointment. University sponsorship is not available for this position.
• A Criminal Background Check will be performed.
• The successful applicant will be required to complete HIPAA training and receive certification upon hire and annually thereafter.

Contact Information:

For questions regarding this position or posting, please contact Melissa Henning, Human Resources Manager, at [e-mail] or [phone].

Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Institutional Statement on Diversity:

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.

The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.

The University of Wisconsin-Madison is an Equal OpportunityEmployer.

Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence by acknowledging skills and expertise from all backgroundsand encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, visit the Human Resources Workplace Poster website.

To request a disability or pregnancy-related accommodation for any step in the hiring process (e.g., application, interview, pre-employment testing, etc.), please contact the Divisional Disability Representative (DDR) in the division you are applying to. Please make your request as soon as possible to help the university respond most effectively to you.

Employment may require a criminal background check. It may also require your references to answer questions regarding misconduct, including sexual violence and sexual harassment. The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7). The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.