About Abzena
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
Role Overview
The Technical Program Manager (TPM) is a technically trained project manager with direct responsibility for guiding integrated development and manufacturing programs through the Abzena San Diego Site processes. The Technical Program Manager is an excellent communicator that manages client relationships by acting as a liaison between customers, internal business partners and functional teams. This role ensures the delivery of contract commitments via thorough planning and active management of each stage of the customer project lifecycle from proposal to closeout. The TPM will play a critical role in advancing biologics from development through manufacturing, directly impacting client success and patient outcomes.
Responsibilities
- Ensures all project documents align with the vision, strategy, and goals of the customer program and accurately follow contract milestones and deliverables.
- Serves as a primary escalation point for internal and external project stakeholders.
- When leading projects, the Technical Program Manager serves as a single over-arching point of contact for all internal and external project stakeholders.
- Develops and maintains detailed project plans for all activities from kickoff to contract close-out.
- Clearly defines the critical path and generates simple, easily interpreted decision criteria for each customer program based on project team recommendations.
- Plans and facilitates interactions between customers and internal project teams.
- Collaborates with workstream sponsors, leads, and team members to identify problems, trends, and impacts on project success along with proposed corrective actions.
- Provides project reports to stakeholders regularly, articulating project status and escalating issues that require additional support.
- Ensures accurate and timely entry and update of all program data to site management and tracking tools.
- Collaborate with the business and technical teams to ensure prospective customer proposals are complete, accurate and communicated in a timely fashion.
- Maximizes project value through collaboration with BD business partners on new proposals and by raising change orders at appropriate times during project execution.
- Plans and manage customer site visits to ensure positive customer experience.
- Monitors customer audit actions through completion.
- Provides guidance and reinforces Project Management best practices to teams during all project phases through one-on-one interactions and group settings.
- Develop and leverage a network across all site functions to ensure established processes are followed.
- Use judgement and discretion to maintain consensus and support among independent stakeholders in a rapidly changing environment.
Qualifications
- BS in life science/engineering or project management related discipline.
- Advanced degree (MS/PhD) desired.
- PMP certification desired.
- Minimum of three (3) years of project management experience in a relevant field leading complex projects/programs.
- Minimum of three (3) years experience managing client relationships.
- Previous Contract Development and Manufacturing Organization (CDMO) experience preferred.
- Strong communication, analytical, problem-solving, organizational, project management, and interpersonal skills.
- Knowledge of and expertise in a range of project management methodologies and tools.
- Demonstrated understanding and strong knowledge of the overall drug development process.
- Previous direct experience working in cGMP environments including an understanding of related regulatory compliance requirements preferred.
- Must be able to work and communicate efficiently with employees on all levels in one-on-one and group settings.
- Demonstrated ability to lead and motivate cross-functional teams and deliver results with minimal supervision.
- Organized, flexible and easily adapts to changing conditions.
- Excellent customer service skills, with a strong bias toward action and owning/resolving issues.
- Proficiency in MS Office Suite, MS Project, MS Visio and Smartsheet. IFS experience preferred.
- Ability to rapidly learn new software and systems.
