OncoMyx Therapeutics is advancing oncolytic immunotherapies with the goal of achieving the greatest therapeutic benefit for more cancer patients. We will improve the effectiveness of therapies and expand their ability to help more cancer patients. To advance the next generation of oncolytic immunotherapies, we have a top team with decades of experience in developing targeted cancer treatments, immunotherapies, and virotherapies who have successfully brought new drugs to market. We is seeking a talented, motivated CMC Project Manager to drive successful internal and outsourced manufacturing programs. This person will be responsible for CMC projects that may include tech transfer, process development, GMP manufacturing, and regulatory submissions components as they related to CMC activities. They will manage project scope, timelines, deliverables, risks, decisions, and alignment across the manufacturing team organization including CMOs, contract analytical labs, and the internal CMC team (quality, analytical, senior management).
Essential Duties and Responsibilities
Qualified candidates will possess the following skills and experience.
- Lead cross-functional project teams with members of Manufacturing, Quality, and Regulatory to support CMC strategy
- Work with CMC functional areas, including external consultants or contractors, to prepare integrated CMC project plans defining goals, milestones, critical path, timelines, risks, and risk mitigation strategies
- Partners with CMC functional leaders to define CMC project strategies and proactively identify and escalate risks, gaps and challenges, key dependencies, and decisions points. Works with teams to develop scenarios and solve problems
- Lead and manage all aspects of CMC project management, including managing CMC project team meetings, team activities, documentation (agendas, minutes), and tracking action items
- Effectively communicate with CMC senior management and program management on program strategy, operational plans, and progress
- Fosters strong relationships and supports effective and impactful communications with management, team members and functional line managers to ensure active management of issues/risks/decisions/opportunities
- Reinforces and supports team operating principles, best practices and team building to ensure effective and high-performing team
Required Experience, Education, and Competencies
- Minimum Bachelor’s degree with Chemistry, Engineering, Biochemistry, or similar technical background
- 5+ years’ experience in project management in pharmaceutical/biotechnology industry
- Experience managing CMO relationships and projects strongly preferred
- Strong understanding of all aspects of biopharmaceutical drug development (regulatory, clinical, manufacturing)
- Working knowledge of ICH/US regulatory requirements
- Strong leadership skills, including demonstrated ability to lead a cross-function team
- Ability to work independently and with flexibility to handle workflow in a fast-paced environment
- Strong foundation of knowledge in project management processes and tools including Smartsheet or MS Project
Preferred Experience, Education, and Competencies
- Experience in project management in CMC function
Work authorization/security clearance requirements:
Must be eligible to work in the United States
Please send CV and cover letter by email to email@example.com. No outside recruiters please.
Affirmative Action/EEO statement: OncoMyx Therapeutics is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Other duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.