What are the responsibilities and job description for the Associate Director, Manufacturing Operations position at Rezolute?
Rezolute is seeking an experienced individual who can help lead its external late-stage manufacturing operations. The Associate Director 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 defining the program and cGMP manufacturing strategy that leads to a robust process for 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 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 for internal colleagues and external stakeholders.
Principle Duties and Responsibilities Include:
- 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
Preferred Experience, Special Skills, and Knowledge:
- Previous management experience with a biologics-based clinical phase biopharmaceutical company or with a biologics CDMO.
Rezolute (RZLT) currently anticipates the base salary for the Associate Director, Manufacturing Operations role could range from $170,000 to $195,000 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.
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.
Salary : $170,000 - $195,000
