• Provide overarching Production-focused thought leadership to Mirus Bio.
• Production Manager for RUO Production Team of Production Scientists (formulation/fill/finish) and Production Chemists (synthesize/characterize small molecules and polymers), including ownership of the associated laboratories, equipment, and processes.
• Partner closely with our Supply Chain Leader to optimize the Production Plan into a Production Schedule.
• Responsible for high-quality RUO Production Schedule execution and driving of operational efficiencies.
• Partner closely with our Scientist III, Production Chemistry for resolution of Technical Production issues.
• Accountable for Production Metrics and Production adherence to the Quality Management System (QMS) including Right First Time, documents, deviations, investigations, change controls, CAPAs, etc. This includes authoring, reviewing, and approving QMS documents and events as needed.
• Responsible for general people leadership and management responsibilities. Includes driving of daily production activities, team huddles and meetings, escalation management, prioritization, workload management, providing technical insight and direction, and issue management/resolution.

• Provide coaching, mentoring, and training on our Technology Transfer processes to all levels of the organization.
• Enhance our Technology Transfer Capabilities through coaching and development of Core Team Members.
• Partner closely with Project Management and Product Management to enhance our Technology Transfer Processes and with the goal of accelerating the launch of high-quality products for our Customers.
• Project Core Team Member and Operations Lead for execution of key Tech Transfer Projects.
• Operations Tech Transfer Project scopes include R&D to RUO Product and RUO Product to GMP Products.
  • R&D to RUO Product includes a wide variety of activities including specification finalization, batch scale-up, RUO production batch records finalization, and QMS adherence.
  • RUO Product to cGMP Product includes a wide variety of activities including CMO and Test Lab selection and qualification, CMO technical and execution oversight, ensuring product adherence to ISO 20399 Biotechnology - Ancillary Materials, and ensuring adherence to Mirus ISO 13485 Certification Scope.

• Drive continuous improvement in all aspects of Production and Technology Transfer.
• Knowledge of the various Mirus Bio quality levels required of R&D, RUO Products, and cGMP Products.
• Comfortable with schedule, task, priority, and project management in an environment of changing priorities, and capable of balancing multiple projects and production activities with overlapping timelines.
• Works closely with other Operations Leaders to balance workloads and optimize operational efficiencies.
• Perform other duties assigned by Director of Operations.

• Bachelor of Science (B.S.) degree or higher in Chemistry, Biology, or related field and 10 years or more of relevant experience.

• Strong leader with ability to develop a team, influence others, and work effectively cross-functionally.
• Experience with GDP and cGMP, ISO 9001 and/or ISO 13485 level (or similar) quality.
• Experience with the Operations portion of product life cycles from R&D thru commercialization including technology transfer.
• Experience with representing a company to Customers and Suppliers in a positive and professional manner.
• Experience with preparation and presentation of reports, data and updates to project and functional teams.
• Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications and establishing personal networks.
• A desire to help others achieve their best and experience as a coach, mentor, and trainer.
• Excellent verbal and written communication skills with attention to detail.
• Proficiency with Microsoft Office including Excel, Word, and PowerPoint.
• Prefer strong scientific and technical competence in biosciences or chemistry.
• Prefer previous experience working for a life sciences company in a laboratory setting.
• Demonstrate behaviors outlined within the Mirus Bio Employee Handbook.

• Ability to travel independently up to 10% of the time, including overnight travel.
• Ability to drive a vehicle; Must have current and valid U.S. driver license.
• Ability to travel by air; Must have current and valid U.S. passport or the ability to gain a passport within the first 6 months of employment.

• Empower
• Passion
• Integrity
• Compassion
• Collaboration
• Innovation

EEO/AA Statement

Mirus Bio is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits and training. Mirus Bio makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Accommodation Statement

Mirus Bio is committed to the inclusion of all qualified individuals in the hiring process, including but not limited to those with disabilities. If you require reasonable accommodation(s) to participate in the application or interview process, please contact HR@mirusbio.com.