Redwood City, CA/Bend, OR/Remote
A key member of the Rezolute leadership team, the VP of Global Product Supply (GPS) has the mandate to provide the vision, leadership, strategy and management skills to build, lead and oversee the team’s transition from the development and supply of proprietary preclinical and clinical stage programs to a fully externalized, globally enabled and integrated manufacture and supply team, supporting direct and partnered markets. In particular, the VP of GPS will have oversight over the company’s out-sourced development, manufacturing and supply chain infrastructure, supporting the submission, approval, launch and supply of RZ358, globally. The position reports to the SPV of Corporate Development, working daily in collaboration with the VP of Quality, New Product Planning, Regulatory and the RZLT Management Team, while acting as a pivotal source of information for the Board of Directors.
Principle Duties and Responsibilities Include
- Charged with designing, developing and implementing the transition of the existing, clinically oriented, CMC function(s) toward a robust and reliable manufacturing and supply group, positioned to support global markets. In this, the organization must maintain its agile operational capability while installing the rigidity necessary to meet market demand through use of a fully externalized network of vendors. In this, the GPS leader will partner closely with the VP of Quality to deliver a unified, robust manufacture and supply platform, suitable for scale of global supply.
- The VP of GPS will outline a vision, strategy and plan to methodically transform the team and deliverables to support the commercialization of Rezolute’s first marketed program, RZ358 for multiple indications and markets.
- Develop key functional areas (including their people, their processes and execution) to include external manufacturing, supply chain and manufacturing, science and technology (MSAT) to support the readiness, filing and supply of RZ358.
- Responsible for continued leadership of early to late phase pipeline CMC development programs, including all outsourced development and manufacturing operations activities and budget for the company’s ; Work in collaboration with the research, clinical development and operations, regulatory and business teams support clinical and regulatory timelines. With this, the successful candidate will play a key role in developing and implementing integrated CMC strategies (regulatory and finished drug supply) for Rezolute’s pipeline projects.
- Accountable for global CMC submissions in concert with Quality and Regulatory teams; This role will oversee and plan for on-time readiness of CMC sections for multiple product registrations supporting the evolving pipeline.
- Accountable for an externalized manufacturing, shipping, distribution, labeling, packaging and storage, via a global network of qualified vendors; Responsible for the processes utilized by Rezolute to manage and oversee vendor readiness and execution to ensure Right First Time, On Time In Full supply to clinical and commercial supply chains.
- Oversees, manages, and provides development opportunities for personnel in all areas of pharmaceutical development, manufacturing, planning, procurement, logistics, and production control.
- Works with GPS and Quality staff and peers to develop policies, processes and programs that ensure efficient workflow and the production of high-quality drug product and associated documentation. Ensures development processes comply with regulatory requirements to minimize risk to the organization and addresses the analysis and evaluation of process development procedures and practices to ensure compliance with regulatory, legal and good manufacturing procedures to attain corporate goals.
- Areas of specific key responsibility will include:
- Build, lead, manage and develop a best-in-class, high-performance team and related support functions. Provide effective leadership to the organization to ensure the development of the business and its people. Manage the organization to accommodate anticipated growth and to ensure technical strength across all levels. Ensure operations and technical leadership, and all departmental associates have development opportunities and plans for career advancement, are provided with routine and useful feedback, have personal goals aligned with corporate, program team, and brand goals and a clear understanding of how their work directly impacts patients and is relevant to the success of Rezolute.
- Develop and generate strategy and then implement a global supply chain and inventory risk management procedures.
- Work diligently with the VP of Quality to ensure compliance of operation and procedure, supporting the VP of Quality with respect to registrational compliance evaluation, and ongoing release of drug.
- Ensure appropriate technical and managerial oversight of external CDMOs, 3PL, Distribution / Depots and related service providers, to ensure right first – on time production to supply clinical studies in compliance with Global Health Authority Regulations as well as regional requirements and ICH Guidelines.
- Oversee functional efforts to optimize existing processes, scale-up efforts and solve complex manufacturing issues in a compliant and timely manner.
- Responsible for assessing and analyzing information resulting in recommendations for long-term manufacturing solutions, including new manufacturing sites and facilities, that are aligned with the corporate strategy and evolving goals.
- Support product launches by ensuring practical and cost-effective manufacturing and analytical approaches.
- Sets priorities, measures results, assesses and implements new learnings for continual improvement, and reports progress to the executive staff and the CEO.
- Routinely assess and define risks associated with in the span of control, create and implement effective mitigation plans, and escalate as appropriate.
- Ensure the management of all financial aspects of the supply chain including budgeting, forecasting, long-range planning and overall management and accountability of product supply. Help lead development of the company’s supply chain strategy, the annual global business goals and tactical implementation plans in collaboration with the other members of the management team, including effective involvement of direct reports and communication with colleagues.
- Work collaboratively with regulatory affairs colleagues to help manage, direct and monitor the preparation, assembly and filing of CMC regulatory submissions to support new product approvals and existing brands, including interactions between the company and health authority representatives to facilitate IND, BLA and other submissions. Directly accountable at the executive level for the accuracy and quality of all associated documentation, including submissions and query responses provided to regulatory authorities. Ensure compliance with respect to CMC requirements to assure favorable compliance reviews and audits.
- Ensure the organization’s resources are aligned and prepared to support the development, launch, and clinical manufacturing needs for quality production
- Regular interaction with R&D, CMO, Program Management and CMC support teams for continual process improvements.
- Work collaboratively with Quality and Regulatory to oversee establishment of development stage and product appropriate specifications aligned with production capabilities.
- Lead development of relationships and contracts for the procurement of high value and cost- effective services and materials for the company’s products. Coordinate the selection and oversight of component vendors and contract manufacturers. Conduct project management and day-to-day interactions with all related research and contract manufacturing operations for clinical products.
- Ensure all manufacturing agreements are effectively negotiated to meet the near and long term needs of Rezolute in a cost-efficient manner as agreed with legal, finance and functional heads.
- Review technical documentation and summaries to ensure sound rationale, conformance with regulations and existing approvals, and challenge where appropriate the effectiveness of these documents to deliver on the intended purpose.
- Develop plans to accomplish company objectives and achieve long-range and short-term product development objectives.
- Develop departmental budget and product cost structure and identify cost improvement opportunities. Have full budget responsibility and accountability. Review and approve expense and capital budgets for development and manufacturing.
- Hold all department members accountable for establishing the minimal number of processes that enable the most efficient workflow and product in keeping with all relevant International and regional standards and guidelines.
- Understand the team’s current performance levels; define, implement and manage Key Performance Indicators (KPI) both internally and for third party relationships to produce results that are cost-effective, mitigate risk and ultimately have a positive effect on daily operations that add value for the company.
Qualifications/Requirements – We are looking for a candidate with:
- B.S is required. PhD preferred.
- 10 Yrs+ in progressive CMC, Process Development, Manufacturing and Supply Chain leadership roles within like Lifesciences organizations; Start up / Biotech launch experience preferred; Biologics process and manufacture experience preferred.
- They should have a track record of establishing a global commercial product supply chain and having had successful interactions with the regulatory agencies, as demonstrated by timely global CMC submissions, approvals and clinical and commercial supply of pharmaceutical compounds, specifically biologics drugs.
- Candidate should have comfort in leading through influence, acting with agility, leading problem solving and driving toward robust solutions; Communication is a critical strength, demonstrated at all levels of the organization; Sense of humor and humility are essential
- Position may require /morning, evening and/or weekend commitments as the RZLT team is spread across the US, and vendors located offshore.
- Position may require domestic and international travel (up to 50%)
Interested and qualified candidates should send their resume to firstname.lastname@example.org to the attention of Human Resources.
Rezolute (RZLT) currently anticipates the base salary for the VP of Global Product Supply role could range from $280,000 to $320,000 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.