CMC Project Manager

Back to Careers

Location: Bend, OR or REMOTE

Company Description
  • Rezolute is a clinical-stage biopharmaceutical company dedicated to developing transformative therapies for patients suffering from debilitating metabolic diseases.
  • Rezolute’s lead clinical asset, RZ358, is a monoclonal antibody in late-stage development for the potential treatment of Congenital Hyperinsulinism (HI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas.
  • The company’s second clinical-stage asset, RZ402, is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME)
  • Rezolute has received orphan drug designation in the United States and European Union as well as a rare pediatric disease designation, for RZ358, enabling eligibility for a priority review voucher.
  • More information can be found at rezolutebio.com
Position Description
Overview

Rezolute is looking for a motivated, independent, and action-driven CMC project manager. The position requires a skilled communicator that has experience in cross-functional project management and working knowledge of CMC operations. The CMC Project Manager role is critical for coordination of CMC and Quality activities of drug development programs in Rezolute’s portfolio. Under supervision of a CMC Program Leader, this position supports partnerships and ensures deliverables are met both internally and with contract development and manufacturing organizations (CDMO’s). Individuals are team-oriented and expected to act as a key point of contact for internal colleagues and external stakeholders.

Principle Duties and Responsibilities Include:
  • Project management of drug substance and drug product development, manufacture, material deployment, and maintenance.
  • Work closely with the CMC Program Director to develop, track and manage integrated CMC/Quality plans and timelines while ensuring deliverables and activities are aligned across all functions.
  • Ensure that CMC and Quality project timelines and dependencies feed into the integrated master project plan and timeline.
  • Identify project risks, gaps, and develop and manage appropriate mitigation strategies.
  • Review CDMO contracts for completeness and generate Purchase Orders for approval.
  • Aid in the management of the CMC project financial management system working with the CMC Program Leader and Rezolute Finance department to account for Scopes of Work pricing, purchasing, invoicing, demonstration of earned value, and budget.
  • Effectively manage team meetings, including the scheduling of meetings, the preparation and distribution of agendas, the development and distribution of meeting minutes and tracking of action items.
  • Facilitate day-to-day communication to ensure clarity, completeness, transparency, and ensure the team is set up to successfully deliver on all CMC project commitments.
  • In combination with QA Document Control and QA GMP Manufacturing leads, help manage Documentation Management for Pharmaceutical, Analytical, Formulation Process Development, and corresponding cGMP activities. Partner daily with Rezolute CMC SME’s, Quality teams and our external vendors to ensure timely receipt, review, approvals, and introduction to our QADC system. 
  • Leads and tracks the CMC technical document management function.
  • Support CMC SME’s with 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.
  • Support and Track CMC content for regulatory filings (IND/IMPD for CTA and BLA).
  • Contributes to best practices, develops value-added PMO tools, and periodically seeks feedback on project management.
Qualifications/Requirements:
  • Minimum Bachelors’ degree in scientific/technical discipline.
  • Minimum 5 years total relevant experience (including industry, project management, or private/government institution), with at least 3 years in a define project management role.
  • Understanding of biotech, cGMP requirements for Upstream and Downstream Biologics Drug Substance development/manufacturing, and/or Aseptic Drug product development/manufacturing.
  • Ability to work independently as demonstrated by establishing their own daily work schedule based on priorities provided by the CMC Program Leader.
  • Demonstrated ability to create, organize and update a complex schedule.
  • 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.
  • Strong attention to detail.
  • Able to effectively manage work performed by staff working remotely.
  • Strong risk management analysis and project management skills.
  • Enjoys describing complex project related activities in a clear and succinct manner.
  • 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 Excel, Word, PowerPoint, Project and/or Smartsheet.
Preferred Experience, Special Skills and Knowledge:

Previous project management experience with a biologics-based clinical phase biopharmaceutical company or with a biologics CDMO.

To Apply:

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

QA Director, GCP

Back to Careers

Location: Redwood City, CA / Bend, OR/Remote

Company Description
  • Rezolute is a clinical-stage biopharmaceutical company dedicated to developing transformative therapies for patients suffering from debilitating metabolic diseases.
  • Rezolute’s lead clinical asset, RZ358, is a monoclonal antibody in late-stage development for the potential treatment of Congenital Hyperinsulinism (HI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas.
  • The company’s second clinical-stage asset, RZ402, is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME)
  • Rezolute has received orphan drug designation in the United States and European Union as well as a rare pediatric disease designation, for RZ358, enabling eligibility for a priority review voucher.
  • More information can be found at rezolutebio.com
Position Description

The QA DIRECTOR, Good Clinical Practices (GCP) at Rezolute is a dedicated Quality leader and is responsible for all aspects of Quality Assurance GCP activities to ensure quality assurance and compliance of Rezolute sponsored clinical trials with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, Rezolute Standard Operating Procedures (SOPs), and current industry standards and practices. The QA DIRECTOR, GCP will establish, maintain, and ensure effectiveness of quality programs and documentation to assure GCP compliance and inspection readiness.

The QA DIRECTOR, GCP is a specific role within the Rezolute’s Quality organization and performs key activities to support Quality Assurance processes specific to the product development plan for Rezolute’s clinical phase programs.  This role is a team partner with Quality Control (QC), Quality Assurance, GMP and Quality Compliance (QComp).  The QA DIRECTOR, GCP provides the quality oversight for all GCP related Contract Research Organizations (CROs), and contract laboratories supporting both clinical and pre-clinical animal studies and will facilitate and drive all product Quality related issues, with support and guidance from the Quality organization.

The QA DIRECTOR, GCP will also serve to collaborate with the Pre-Clinical and Clinical groups to ensure that phase appropriate and proportionate regulatory requirements and guidelines are reflected in their processes. The QA DIRECTOR, GCP will partner with the QA Compliance organization to incorporate key elements in the Rezolute QMS, if applicable.

Principle Duties and Responsibilities Include:
  • Provides GCP oversight and support for clinical operations in ongoing and planned human clinical trials as well as pivotal GLP pre-clinical studies.
  • Work collaboratively with internal Clinical Operations Team to ensure compliance standards are achieved.
  • Develops, guides, and reviews, protocols and reports employed in the conduct of GCP activities
  • In partnership with QA Compliance and Clinical Operations, manage GCP audit program to include routine and non-routine quality assurance audits of clinical vendors, processes, systems, study documents and investigator sites, to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines
  • Develop and implement detailed audit plans and yearly GCP audit schedules, in coordination with QA Compliance and Clinical Operations.
  • Review and approve Clinical Operations SOPs.
  • Develop and Implement Clinical QA SOPs as they relate to Rezolute’s organization and set-up.
  • Prepare audit agendas and reports and communicate findings with recommendations for corrective action plans.
  • Lead and ensure the timely and effective follow up of all identified or assigned quality issues.
  • Conduct QA oversight of GCP protocols, ICFs, CSRs and other clinical trial specific documents as needed.
  • In coordination with QA Compliance and Clinical Operations, direct or perform CSR audits and eTMF audits as needed.
  • Direct and/or deliver yearly GCP training for internal staff.
  • Work closely with Pre-Clinical, Clinical Operations, and other departments to ensure compliance readiness.
  • Reviews and authors Quality owned sections of regulatory submissions
  • Liaises with other Quality department staff to ensure an aligned, single voice of Quality.
  • Provides technical quality and/or strategic support to clinical vendors and sites during product pre-approval inspections, and routine GCP inspections as required
  • Interprets and applies applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives in conjunction with the Head of Quality
  • Identify and lead cross portfolio Quality initiatives or improvements that will reduce overall risks as required
  • In conjunction with the Head of Quality, translate complex quality concepts and communicate, as appropriate, across the multi-functional product team
Candidate Profile
Qualifications/ Competencies / Requirements:
  • Proven GXP knowledge through experience of working within the clinical development environment with extensive GCP audit experience.
  • Scientific background with demonstrated (ideally ‘hands on’) knowledge of the clinical environment via a drug development role or a regulatory agency inspector role.
  • Recognized as expert with respect to GCP regulations
  • The ability to proactively identify quality concerns and diligently drive toward solutions
  • Highly skilled in the ability to work remotely, with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
  • Demonstrated ability to communicate effectively in both oral and written domains.
  • Displays comprehensive knowledge in GCP, demonstrates subject matter level expertise.
  • Ability to execute highly complex, specialized, cross-functional processes and projects.
  • Ability to make significant improvements and changes when required in order to maitain proper Quality Management regardless of  the way the work has traditionally been done,.
  • Works independently and may instruct, advise or coach other professionals.
  • Brings a high degree of technical competency to bare upon their decision making process, applying innovative approaches and methods to more complex problems possessing greater technical complexity.
  • Is fully accountable for the delivery of assigned targets/ objectives in a timely manner.
  • Has the capacity to understand the dynamics around the generation of a progressive teamwork environment. 
  • Has the ability to evaluate current methods and practices in light of industry trends, company capabilities and best practices, and offer creative ideas to enhance performance internally.
  • Systematically analyses information to identify the root cause  and able to follow through the solution to implementation. 
  • Has the capacity to monitor the effectiveness of corrective and preventative measures  for a CRO and is able to identify and evaluate the interface of these improvements with Rezolute’s systems. 
  • Acts as a role model in living the Rezolute values
Preferred Experience, Special Skills and Knowledge:
  • 15+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry
  • Demonstrated Quality Management System experience (GCP specific QMS experience preferred).
  • Demonstrated Issue Management and CAPA experience in a clinical environment.
  • Experience with FDA and other global Regulatory Inspections of Sponsors, laboratories CROs and Investigator Sites.
  • Excellent interpersonal and communications skill
  • Ability to influence diverse stakeholder and drive accountability and decision-making cross-functionally
  • Ability to work effectively with stakeholders, company executives and senior Quality partners.
  • Demonstrated ability to partner with other functional groups to achieve business objectives
  • Results oriented; effectively manages multiple projects and a high workload efficiently
  • Excellent written and verbal skills; ability to communicate effectively with all levels of the organization; effective public speaker
  • Builds strong, effective working teams; builds relationships to share best practices, and collaboratively solve problems
  • In-depth understanding and application of cGxP principles, concepts, practices and standards
Education:
  • BA/BS in life sciences or related field
  • Advanced degree desirable, but not required
  • Other continuing education initiatives or relevant industry or compliance certifications
Other:
  • Ability to travel up to 20% as required
To Apply:

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

Sr. Accountant

Back to Careers

Location: Redwood City, CA

Company Description
  • Rezolute is a clinical-stage biopharmaceutical company dedicated to developing transformative therapies for patients suffering from debilitating metabolic diseases.
  • Rezolute’s lead clinical asset, RZ358, is a monoclonal antibody in late-stage development for the potential treatment of Congenital Hyperinsulinism (HI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas.
  • The company’s second clinical-stage asset, RZ402, is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME)
  • Rezolute has received orphan drug designation in the United States and European Union as well as a rare pediatric disease designation, for RZ358, enabling eligibility for a priority review voucher.
  • More information can be found at rezolutebio.com
Position Description
Principle Duties and Responsibilities Include:
  • Maintain general ledger by inputting daily financial transactions
  • Support the day-to-day accounting operations
  • Actively participate in the monthly, quarterly, and year-end close process
  • Collaborate with the Clinical and CMC Departments to ensure accuracy and completeness of accruals, which may include reviewing and analyze contracts and change orders, vendor financial reports and invoices, compare and reconcile data to purchase orders, budgets, work orders, to prepare the accrual journal entries
  • Prepare monthly journal entries for recurring expenses, payroll, accruals, prepayments, allocated expenses, and adjusting entries
  • Support the preparation of month/quarter end financial statements
  • Assist in quarter-end reviews and year-end audit with the Company’s external auditors, including preparation of audit schedules and requests
  • Collaborate with FP&A and various departments to support business initiatives
  • Assist in the process of maintaining documentation surrounding and in improving our internal control structure
  • Participation in process improvements, financial system enhancements and special projects as needed
Qualifications/Requirements – We are looking for a candidate with:
  • Highly self-motivated with a strong work ethic
  • Thriving in a team-oriented environment and also highly functioning independently as needed
  • Committed to delivering results of the highest quality on a timely basis
  • Detail-oriented in planning and execution
  • Positive and outgoing
  • SOX experience
  • Experience with NetSuite is a plus
Preferred Experience, Special Skills and Knowledge – We are looking for a candidate that is:
  • An undergraduate degree is required. Former life science experience is highly desirable
  • 5+ years of relevant experience in a finance or accounting role required
  • Strong understanding of US GAAP, including ASC718 and ASC842
  • Proven ability to quickly learn and grasp the interdependencies in a complex environment
  • Advanced user of Microsoft Excel required
  • CPA desirable
  • Equity Edge Online experience a plus
To Apply

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

Michael B (CMC)

Back to Careers

“I joined Rezolute because of its resilient team and dynamic drug pipeline. I remain continually impressed by the relentless individuals I collaborate with daily, and the speed in which data is processed and thoughtful decisions are made.”