Process Development and Manufacturing Manager

Job Category: Academic Staff · Employment Type: Regular · Department: Waisman Center

About the role

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.

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

Requirements

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

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.

Pay

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

Benefits

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.

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.