Location: Bend, OR; Redwood City, CA; Remote with Travel

Company Description

Rezolute is a biopharmaceutical company seeking an experienced individual who can help lead its external late-stage to commercial manufacturing operations. Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI).

Position Description

The Sr Manager of Manufacturing Operations is expected to be a motivated, independent, and action-driven individual who understands the intricacies between Pharmaceutical Manufacturing and Quality Assurance. This role is fast-paced and will be responsible for executing manufacturing strategy that leads to a robust supply, right first time and on-time, supporting multiple Phase 3 global trials, and the commercialization of RZ358.

Under the supervision of the Senior Director – Supply Operations, this position manages partnerships and ensures deliverables are met both internally and with contract development and manufacturing organizations (CDMO’s). Responsibilities include oversight of multiple Drug Substance (DS) and Drug Product (DP) sites (and vendors) to ensure deliverables are achieved based on the approved plan. This role will act as a technical lead while also interacting with internal SME’s (MSAT and QA) to ensure proper execution. Individuals are expected to be team-oriented and to act as a key point of contact across a multifunctional internal team, and external stakeholders.

Duties and Responsibilities:

• Responsible for the manufacture of DS and DP based on approved plan; acts as technical and business lead where applicable
• Review all CMO contracts to ensure scope(s) and deliverables meet defined strategy
• Liaison with Internal SME’s (MSAT and QA) to ensure activities are fully coordinated with the POR
• Lead Internal MFG Operational Alignment Meetings
• Develops facility fit assessments and process/facility gap assessments to enable Technology Transfers to future CMO’s
• May act as person-in-plant and technical advisor during tech transfer, start-up, validation studies and clinical manufacturing
• Ensures Master Batch Records and product specifications are finalized and in place prior to any cGMP manufacturing
• Manages the overall supply and inventory of drug substance and drug product
• Authors, reviews, and approves technical reports
• Attend internal and external technical sub-term meetings to ensure alignment and conformance with the plan of record (POR)
• Participate in the generation and execution of the integrated Global Supply plans and timelines, ensuring manufacturing deliverables and activities are aligned across all functions, and confirms dependencies feed into the integrated master project plan and timeline
• Review and provide input into program Gantt charts and Dashboards
• Implement, and, as appropriate, facilitate, cross-functional program/project teams that are empowered to identify program gaps and manage deliverables
• Proactively, and independently, identifies and resolves issues and obstacles, effectively communicating cross functionally
• Help in the management of the manufacturing project financial management system working with the Senior Director – Supply Operations, Senior Manager -Global Supply Planning, and Rezolute Finance department to account for Scopes of Work pricing, purchasing, invoicing, demonstration of earned value, and budget
• Owns GMP documents including change controls, deviations, and standard operating procedures; Partner daily with Quality Assurance to ensure compliance with cGMP regulations and Rezolute Quality Systems in concert with the Rezolute Quality Assurance
• Develop knowledge of the current therapeutic environment and drug development trends as needed

Qualifications/Requirements:

• Minimum Bachelors’ degree in scientific/technical discipline.
• Minimum 8 years total relevant experience (including industry, project management, or private/government institution), biopharmaceutical experience is highly preferred.
• Manufacturing operations management in an equivalent life sciences company; prefer biologics rare disease experience
• Demonstrated understanding of biologics (mAb) cGMP requirements for Upstream and Downstream Biologics Substance development/manufacturing, and/or Aseptic Drug product development/manufacturing
• Clear understanding of clinical FDP execution
• Ability to work independently
• Demonstrated ability to create, organize, and update complex schedules, dependencies, and associated resource
• Proven track record in a fast-paced, challenging, and complex matrixed, remote-work team environment
• High degree of demonstrated learning agility
• Action-oriented with strong follow-through, with demonstrated attention to detail
• Able to effectively manage work performed by staff working remotely
• Strong risk management analysis and project management skills
• Demonstrated ability to outline complex project-related activities in a clear and succinct manner in a cross functional environment
• Ability to understand strategic objectives while focusing on execution of near-term details to meet long-term goals.
• Highly developed interpersonal skills with the proven ability to function effectively and tactfully with multiple departments and personnel in all levels of the organization; able to gain consensus and commitment
• Proficient knowledge of Microsoft Teams, Excel, Word, PowerPoint, and Smartsheet

To Apply

Interested and qualified candidates should send a resume to recruiting@rezolutebio.com to the attention of Human Resources.

Rezolute (RZLT) currently anticipates the base salary for the Senior Manager of Manufacturing Operations role could range from $140,000 to $165,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate. Rezolute offers competitive compensation, stock options and a rich benefits package.

Qualifying employees are eligible to participate in benefit programs such as:

• Health Insurance (Medical / Dental / Vision)
• Disability, Life & Long-Term Care Insurance
• Holiday Pay
• Tracking Free Vacation Program
• 401(k) Plan Match
• Educational Assistance Benefit
• Fitness Center Reimbursement

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.