Associate DirectorManufacturing Development and Operations Project ManagementPosition OverviewThe Associate Director, Manufacturing Development and Operations Project Management is responsible for leading cross-functional Chemistry, Manufacturing, and Controls (CMC) project management activities supporting the development, manufacture, and lifecycle management of monoclonal antibody therapeutics from early clinical development through commercialization. Reporting to the Sr. Director, Manufacturing Development and Operations Project Management (or equivalent), this role serves as a key partner to Technical Operations, Process Development, Analytical Development, Quality, Regulatory Affairs, Clinical Supply, and external manufacturing partners to ensure CMC programs are executed on schedule, within budget, and in compliance with quality and regulatory expectations.
The successful candidate will provide project leadership across drug substance and drug product development, technology transfer, manufacturing, analytical testing, regulatory submissions, and commercial readiness activities. This individual will drive planning, execution, risk management, communication, and decision-making across multiple internal and external stakeholders while establishing a culture of accountability, transparency, and operational excellence. Success in this role requires exceptional organizational and communication skills, strong technical understanding of biologics manufacturing and CMC development, and the ability to influence cross-functional teams without direct authority.
Key ResponsibilitiesStrategic CMC Project Leadership- Lead cross-functional CMC project management activities for monoclonal antibody development programs from preclinical development through commercialization.
- Partner with the Sr. Director, Manufacturing Development and Operations Project Management to provide overall project leadership and coordination, ensuring development activities are executed on schedule, within budget, and aligned with corporate objectives.
- Develop integrated CMC project plans that define scope, timelines, deliverables, critical paths, resource requirements, dependencies, and key milestones.
- Drive cross-functional alignment among Technical Operations, Process Development, Analytical Development, Manufacturing, Quality, Regulatory Affairs, Clinical Operations, Supply Chain, and Program Management.
Manufacturing and Technical Operations- Coordinate manufacturing activities across drug substance and drug product development, including process development, technology transfer, GMP manufacturing, process characterization, process validation, analytical method readiness, release testing, and stability programs.
- Collaborate with internal technical teams and external contract development and manufacturing organizations (CDMOs), contract laboratories, consultants, and vendors to ensure successful execution of manufacturing deliverables.
- Monitor manufacturing schedules, identify critical path activities, anticipate risks, and facilitate timely issue resolution to maintain project timelines.
- Coordinate preparation, review, and tracking of manufacturing documentation including protocols, reports, technical summaries, presentations, and other project deliverables.
Project Planning and Execution- Develop, maintain, and communicate detailed project timelines using appropriate project management tools (e.g., Microsoft Project, Smartsheet).
- Establish project scope, objectives, deliverables, assumptions, and resource plans.
- Monitor project progress through key performance indicators and project metrics, proactively identifying schedule risks and recommending mitigation strategies.
- Lead risk identification, assessment, mitigation planning, and contingency development across CMC activities.
- Maintain project documentation and archives to ensure complete project history, current status, and future planning.
Cross-Functional Leadership and Communication- Lead and facilitate cross-functional project team meetings, prepare agendas, document meeting minutes, assign action items, and track completion.
- Provide clear, concise project communications and status updates to functional leadership and executive management.
- Foster collaboration across internal functions and external partners by promoting transparency, accountability, and timely decision-making.
- Escalate significant risks, issues, and resource constraints appropriately while facilitating resolution.
Budget and Resource Management- Support development of CMC project budgets and forecasting activities.
- Track project expenditures relative to approved budgets and identify potential financial risks.
- Assist in resource planning and prioritization across multiple development programs.
Continuous Improvement- Implement and promote project management best practices, standardized tools, templates, and governance processes.
- Identify opportunities to improve project execution efficiency, communication, and cross-functional collaboration.
- Contribute to the continued development of project management capabilities within the Technical Operations organization.
QualificationsEducation- Bachelor's degree in Engineering, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
- Advanced degree preferred
Experience- 8-12+ years of experience in biotechnology or pharmaceutical development, with at least 5 years of CMC or Technical Operations project management experience supporting biologics programs.
Technical Knowledge- Strong understanding of biologics CMC development, including monoclonal antibody drug substance and drug product development.
- Experience supporting GMP manufacturing, process development, technology transfer, analytical development, process characterization, process validation, release testing, stability programs, and regulatory CMC activities.
- Familiarity with FDA, EMA, and ICH guidelines governing biologics development and manufacturing.
- Experience working with CDMOs and external manufacturing partners.
Skills and Competencies- Excellent project management, planning, organizational, and prioritization skills.
- Proven ability to manage multiple complex projects simultaneously in a fast-paced environment.
- Strong leadership and influencing skills with the ability to lead cross-functional teams without direct reporting authority.
- Outstanding verbal, written, presentation, and interpersonal communication skills.
- Demonstrated ability to identify risks early, develop mitigation strategies, and drive timely decision-making.
- Strong analytical and problem-solving capabilities with exceptional attention to detail.
- Proficiency with project management software (e.g., Microsoft Project, Smartsheet) and Microsoft Office applications.
Preferred Qualifications- Project Management Professional (PMP) certification or equivalent project management training.
- Experience supporting BLA or other global regulatory submissions.
- Experience working within a virtual, matrixed biotechnology organization.
- Demonstrated success managing complex, multi-site development programs involving multiple external partners and global stakeholders.
Work EnvironmentAt Uniquity Bio, we believe every team member has an impact on the patients we aim to serve. We are a nimble team with a rigorous approach to drug development that requires collaboration and transparency to maximize value, reduce risk, and deliver meaningful, best-in-class products. We are looking for self-starters who enjoy working in a complex, collaborative environment and are motivated to bring critical new medicines to people around the world. We are a small, fast-paced organization with a talented team of in-house employees and external consultants. Candidates must be self-motivated and able to work both independently and collaboratively to achieve success and impact in our dynamic work environment.
This is a U.S.-based position. Team members who live within commuting distance of our Malvern, PA or San Diego, CA office locations are expected to spend time in the office, and remote employees are expected to travel to an office on a regular basis. Specific details for both local and remote staff will be discussed and agreed upon on a case-by-case basis with the employee's manager. Business travel may be required depending upon the specific needs of the position.
The above job description is not intended to be all-inclusive. Requirements of the position may change from time to time based on business needs.
