Senior Manager, Manufacturing Operations
Share
Job Location:
Redwood City, CA - USA
Monthly Salary:
$ 165000 - 180000
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Rezoluteis 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 substantialbenefitin clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI).
Rezoluteis seeking a seasoned professional to support its late-stage and pre-commercial external manufacturing operations. The Senior Manager of Manufacturing Operations will be a proactive self-directed individual with a strong technical foundation and a clear understanding of the interface between Pharmaceutical Manufacturing Quality Assurance and external partners. This role requires the ability to interpret and communicate complex manufacturing information effectively across internal teams business stakeholders and CDMO partners.
This fast-paced role supports execution of manufacturing strategies that ensure reliable right-first-time and on-time supply to support global clinical trials and commercialization of RZ358. Reporting to the Senior Director of External Manufacturing this position supports partnerships with contract development and manufacturing organizations (CDMOs) and contributes to delivery of project milestones across multiple Drug Substance (DS) and/or Drug Product (DP) sites. The individual will work closely with internal SMEs (MSAT and QA) Business stakeholders and Supplier Relationship Management (SRM) to ensure coordinated execution of manufacturing activities.
Principle Duties and Responsibilities Include:
Support execution of Drug Substance (DS) and/or Drug Product (DP) manufacturing in accordance with approved plans ensuring alignment with program timelines supply requirements and business priorities
Serve as a technically informed liaison to internal SMEs (MSAT and QA) Business stakeholders and Supplier Relationship Management (SRM) to help ensure manufacturing activities are coordinated and aligned with the Plan of Record (POR)
Apply technical understanding of biologics manufacturing processes to support clear and effective communication across internal teams and CDMOs
Work closely with Supplier Relationship Management (SRM) Business stakeholders and Procurement (PO) to support scheduling material readiness and confirmation of manufacturing operations
Support and help facilitate internal Manufacturing Operations alignment meetings to ensure cross-functional visibility and coordination
Assist in coordination of technology transfer start-up activities validation and clinical/commercial manufacturing to support continuity across CDMO partners
Participate in internal and external technical sub-team meetings including supplier-facing forums to ensure consistency in communication and alignment to program and business objectives
Support development and collection of manufacturing risk assessments; track risks and help ensure mitigation plans are progressing and visible to stakeholders
Monitor manufacturing KPIs and communicate trends risks or issues to leadership Business stakeholders and SRM as appropriate
Coordinate Master Batch Record (MBR) and Electronic Batch Record (EBR) review and approval workflows to ensure completeness and compliance
Support tracking and progression of manufacturing change controls (internal and CDMO) through to closure
Partner with QA and CDMOs to track and support resolution of deviations and investigations
Support alignment of Manufacturing Supply Operational Plans with internal forecasts program timelines and business objectives
Facilitate coordination of internal SMEs (QA MSAT) and stakeholders to support timely execution of program deliverables
Provide input into manufacturing-related scopes of work and contracts to ensure alignment with operational needs supplier capabilities and program strategy
Support collaboration with Supplier Relationship Management (SRM) to ensure effective oversight of CDMO performance and partnership health
Support tracking of manufacturing activities against budget and scope in collaboration with Finance Business stakeholders and leadership
Contribute to development and use of PMO tools and manufacturing project management best practices
Interface with PMO to support alignment of Tech Ops activities with broader program and business goals
Support readiness activities for late-stage and commercial manufacturing ensuring processes and documentation are aligned for scale compliance and supplier execution
Qualifications/Requirements:
- Minimum Bachelors degree in a relevant scientific discipline
Minimum 8 years of relevant experience (industry project management or related) withsmall to mid-sized biotechexperience preferred
Demonstrated technical understanding of biologics (mAb) manufacturing including Drug Substance (upstream/downstream) and/or aseptic Drug Product operations
Ability to apply technical knowledge to support cross-functional communication and decision-making across Technical Operations Business teams and external partners
Experience working with CDMOs and supporting external manufacturing operations; exposure to supplier or business interface is preferred
Strong organizational and project coordination skills with the ability to manage multiple activities and timelines
Demonstrated ability to work independently in a fast-paced matrixed environment
Strong attention to detail and ability to track complex deliverables to completion
Effective interpersonal and communication skills with the ability to work across technical operational and business functions
Basic understanding of cGMP requirements and quality systems including change controls deviations and batch record review
Proficiencyin Microsoft Teams Excel Word PowerPoint and Smartsheet
Rezolute(RZLT) currentlyanticipatesthe base salary for Senior Manager Manufacturing Operations role could range from $165000 to $180000and will depend in part on the successful candidates geographical location and their qualifications for the role including education and experience. This position will also be eligible for an annual performance bonusin accordance withthe terms of the applicable plan (depending in part on company and individual performance and at the Companys 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 educationexperienceand geographical location of the selected candidate.
Qualifying employees are eligible toparticipatein 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.
Required Experience:
Senior Manager
About Company
Rezolute is a clinical‑stage biopharmaceutical company developing transformative therapies—such as the monoclonal antibody ersodetug (RZ358) in Phase 3 for congenital hyperinsulinism and the oral plasma kallikrein inhibitor RZ402 in Phase 2 for diabetic macular edema—to treat rare met ... View more
