Clinical Program Manager

At Azenta new ideas new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.

All we accomplish is grounded in our core values of Customer Focus Achievement Accountability Teamwork Employee Value and Integrity

Job Description

Overview

We are a leading third-party logistics (3PL) provider seeking an experienced Program Manager to lead a team overseeing a portfolio of customer projects involving GMP and GTP material storage and distribution. These materials include small molecules large molecules and biologics used in the development and production of therapeutic and diagnostic products for the life sciences market.

This role requires deep subject matter expertise to guide both customers and internal teams in the compliant execution of regulated logistics programs. Success in this role hinges on strong cross-functional collaboration across Commercial Quality Regulatory and Operational teams.

How Youll Add Value

The Clinical Program Manager is expected to manage a portfolio of client studies and/or assume special assignments including but not limited to: department liaison specific to their service line assignment mentoring responsibilities leading process improvement projects leading initiatives with departmental impact and beyond etc.

What Youll Do

Serves as key contact for responsible client(s); Liaison between Clients CROand Azenta. Displays strong leadership to ensure successful interactions between Azenta Project Management Organization (PMO) team members needed to provide seamless study delivery to the client. Provides project management oversight focusing on key client deliverables through enhanced budget risk and milestone management. Facilitates communications between Client and extended Azenta team. Manages a portfolio of global high-complexity projects. Acts as an ambassador on behalf of the client across all Azenta business units. Ensures that all customer expectations are documented and acted upon in compliance with regulatory/quality requirements. Demonstrates through appropriate self-organization the ability to manage conflicting priorities and to make difficult decisions. Acts efficiently in an environment with dynamic timelines and priorities. Demonstrates accountability for the implementation monitoring and reporting of performance metrics in alignment with PMO Leadership for their respective service line(s). Actively participates in and supports culture of Azentas development through continuous process improvement quality and productivity initiatives. Works with appropriate internal and external personnel to understand the culture and pipeline of assigned clients. Demonstrates strong interpersonal and communication skills that will build strong internal and external relationships to ensure deliverables are on time. Participates in functional meetings and provides input keeping processes up to date. Acts as the subject matter expert in pre-sale meetings with customers.

Key Responsibilities

• Serve as a Subject Matter Expert (SME):
  Lead customer conversations pre- and post-sale regarding regulated product storage and distribution. Mentor team members to develop SME-level expertise.
• Project Execution & Compliance:
  Coordinate internal resources to ensure services meet:
  • Cold chain requirements specific to each product
  • Import/export regulations and governing body requirements (e.g. FDA EMA PDMA etc.)
• Partner Management:
  Identify and onboard external partners including other 3PL providers to support project execution.
• Documentation & SOPs:
  Lead the development and maintenance of SOPs and audit-ready documentation for all storage and logistics operations.
• Audit & Inspection Coordination:

Act as the primary point of contact for regulatory inspections and audits related to storage and distribution activities.

What You Will Bring

• BS/BA degree in science or related field and minimum 3 years of project management experience OR
• Associated degree in science or related field and minimum 4 years of project management experience OR
• CSPO CSM PMP preferred
• High School Diploma or its equivalent and at least 5 years of Project Management Experience
• Proven track record of complex client account management governance oversight of client accounts mentoring and working across departmentally
• Experience working in an FDA and GXP regulated environments.
• Strong organizational skill and attention to details
• Excellent verbal and written communications skills
• Demonstrated high degree of initiative and ability to work collaboratively
• Demonstrated ability to prioritize work customers internal and external demands
• Demonstrated expertise in leading change
• Proven record of driving continuous improvement and successful project completion

• 5 years of experience in GxP logistics regulated material handling or a related field
• Proven success managing 3PL services and compliant storage programs
• Strong working knowledge of global trade compliance and regulatory frameworks
• Familiarity with the drug development lifecycle including investigational and commercial supply chain needs
• Excellent communication and project management skills with a track record of leading cross-functional initiatives
• Demonstrated leadership experience with the ability to develop and inspire teams

Your Working Conditions:

• General office setting
• Employee may occasionally work in an area with potentially infectious materials.
• Employee will be responsible for maintaining a clean work environment and enforce and follow Universal Precautions for bloodborne pathogens when working in an area considered to be potentially contaminated.

EOE M/F/Disabled/VET

If any applicant is unable to complete an application or respond to a job opening because of a disability please email at for assistance.

Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race color age religion gender sexual orientation gender identity national origin disability or veteran status.

The posted pay range for this position is an estimate based on current market data and internal pay structure. Final compensation may vary above or below this range depending on factors such as experience education (including licensure and certifications) qualifications performance and geographic location among other relevant business or organizational needs.