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Project Manager-CMC Biologics and CGT Operations
3 months ago
Project Manager
Title: Project Manager – CMC Biologics and CGT Operations
Location: Exton PA
Reports to: VP, Biologics and CGT Operations
Full-time
Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
The Project Manager (PM) will be part of the CMC Biologics, Cell and Gene Therapy (BCG) organization. This role will support client scope, cross-functional Product Testing Team(s) (AD and GMP) to assist in the planning and execution of strategic projects. The role will interface with analytical development and GMP teams as the project manager responsible for the execution of client specific or tech transfer projects at Frontage Labs. The role of the Project Manager is to work closely with other departments, leading and managing activities for assigned projects. The Project Manager will lead, coordinate, and facilitate in assigning and leading projects, providing project management direction, and helping to drive the overall strategy for the departments by:
- Influencing and maintaining effective collaborations across the network, closely partnering with Quality, Finance, Global Regulatory Sciences, Analytical Development and GMP Services
- Interacting with Technical SMEs and department senior leadership teams to establish metrics and KPI for client project deliverables.
- Acting as the interface between CMC BCG and clients for communications related to scheduling, milestone assignments and escalation of issues critical to successful completion of the projects.
Roles & Responsibilities:
- Accountable for the project management of CMC technical projects, including execution of key tech transfers to Frontage Labs
- Coordinate and facilitate the creation of project plans that are aligned with Client’s proposal.
- Lead and sustain a high performing project team of technical subject matter experts.
- Attend project meetings to communicate project performance to department leadership and gain project initiation, execution, and re-baseline endorsements from stakeholders.
- Develop and monitor the project milestones and proactively communicate risks and changes.
- Ensure projects are chartered and projects are executed on-time and within budget.
- Leverage project management tools and methodologies to track project execution. Create project plans, scope, work, resources, scheduling, etc.
- Owns and drives multiple projects from inception through completion.
- Defines integration needs with other projects, systems, and business processes.
- Provides project status reports and communications to internal stakeholders. Interfaces with senior management on project escalation issues.
- Resolves scheduling and inter-functional conflicts. Identify and resolve issues and risks.
- Creates and maintains comprehensive project documentation.
- Leads daily, weekly, or monthly project status meetings. Reviews, tracks, and reports on project tasks and identifies deviations or adverse trends. Evaluate and assess result of the project through regular after-action reviews.
Education, Experience & Skills Required:
- Bachelor’s degree in Life Sciences-related discipline. Advanced degree in Life Sciences-related discipline and/or an MBA strongly preferred.
- Minimum of 5 years of project management experience within the Biotech/pharmaceutical / biotech industry. Cell Therapy experience is a plus.
- Strong knowledge of biopharma industry. Familiarity/experience with end-to-end drug development. Experience with Chemistry, Manufacturing & Controls (CMC) desirable
- Experience operating in a highly matrixed & cross-functional organization strongly preferred.
- PMP certification is desirable.
- Proficiency with related software tools such as: MS Project, One Pager, Smartsheet, MS PPT, MS Excel, SharePoint, etc.
- Excellent interpersonal, communication, and presentation skills.
- Ability to work cross-functionally, with matrixed teams, maintaining strong business partner relationships.
- Strong leadership skills and executive presence; ability to positively influence outcomes.
- Expertise in conflict resolution.
- Excellent critical thinking and problem-solving skills.
- Willingness to do what needs to be done in a dynamic environment.
- Demonstrated ability to effectively navigate ambiguity and complexity and translate into accomplishing challenging goals & objectives.
- Demonstrated aptitude for collaboration, relationship building, and influencing without authority in a matrixed environment.
- Demonstrated effective organizational skills to manage a large book of work and competing priorities.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
