Project Manager II - CDMO, Drug Product, GMP

Job Summary

The Project Manager II - Drug Product is an essential partner with the Operations and site leadership team and is accountable for driving results in a dynamic environment by driving projects to completion. The Project Manager II has a strong scientific and technical understanding of Alcami services with the ability to effectively interact and communicate directly with highly educated, innovative industry thought leaders. The Project Manager II leads cross-functional project teams to deliver against contracted commitments and timelines. The Project Manager II must have in depth knowledge of a product lifecycle through the regulatory phases from pre-clinical to commercialization to identify and propose the necessary activities to achieve successful regulatory approval. This role includes assessing the scope of services in the contract and developing project plans, directing project activities, tracking project status, and serving as the primary point of contact for all customer communications.

On-Site Expectations

Hybrid role with up to 60% expected on-site, depending on project requirements. 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Establishes, leads, and manages a project team of technical and scientific team members to deliver against contracted commitments and timelines for Alcami services.
• Assesses the scope of services included in the contract and creates a detailed timeline outlining actions, deliverables, and risks.
• Identifies and requests resources, including technical and scientific resources required to execute the project from functional areas (i.e. operations, formulation development, analytical development, quality, engineering, etc.).
• Reviews the contract scope and project schedule with the project team to identify gaps, risks and additional proposed services that may be required to successfully execute the project.
• Communicates with the Business Development on any required items that are out of scope and may require amendment to the contract.
• Leads the project kick-off meeting with the customer introducing the team and presenting the scope, timeline, risks and proposed additional activities.
• Leads project team activities and actions, monitoring progress against the established timelines and providing regular updates to the internal stakeholders and customers.
• Leverages own technical and scientific knowledge to recognize and manage activities at risk to exceed timeframes or scope of the contract.
• Resolves conflict by providing proactive escalation of project or customer relationship issues to internal stakeholders and provides a proposed corrective course of action.
• Manages the response and action plan with the customer to resolve conflict.
• Maintains accurate timelines, monitors forecasted revenue, and tracks and manages GMP documentation through Master Control, the Company's validated electronic document management system.
• Updates site files used to calculate and display project metrics such as Right First Time, On Time Delivery and Schedule Adherence.
• Demonstrates fiscal responsibility to monitor, forecast and calculate the profitability of the assigned project(s).
• Generates change orders and works closely with Business Development to generate new proposals for additional work associated with the project.
• Serves as main point of contact for the customer for all project related activities and issues, including any questions or disputes related to invoices.
• Partners with the Director of Project Management to implement improvements to the Project Management processes and systems.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Qualifications

• Bachelor's degree in a scientific discipline required. Master's degree preferred.
• 3 years of related pharmaceutical or biotech experience required.
• 2 years of experience leading multi-disciplinary project teams in a service business required.
• 3-5+ years of experience in project management required.
• CMO or CDMO experience preferred.
• Prior experience in a customer-facing role required.
• Formal project management training or certification preferred. PMP certification desired.

Knowledge, Skills, and Abilities

• Technical and scientific knowledge and understanding of Alcami services within the customer's project and contract.
• Knowledge of a product life cycle through the regulatory phases from pre-clinical to commercialization to identify and propose the necessary activities to achieve successful regulatory approval.
• Technical and scientific aptitude to lead the Drug Product project team, set reasonable timelines and milestones.
• Ability to interact and communicate confidently and represent technical details when speaking with innovative thought leaders and highly educated individuals (Master's Degree, PhD, Physicians, etc.), both internal stakeholders and Alcami customers.
• Ability to organize and run business/project review meetings with a joint steering committee comprised of senior leaders representing Alcami and the customer.
• Ability to answer impromptu questions and provide real-time updates.
• Ability to drive successful resolution when conflict arises between Alcami and customer timelines, either by challenging and influencing the project team to adjust their course of action or to advocate for Alcami's position to the customer for successful resolution.
• Knowledge of multiple validated GMP systems and strong business acumen to understand contracts and financial impacts.
• Superior organizational skills and efficiency at updating and maintaining multiple files in a variety of systems.
• Ability to manage multiple and often competing priorities; both technical or business impacts.
• Excellent verbal and written communication and presentation skills.
• Ability to motivate and influence others and facilitate all SMEs associated with various projects.
• Proficient in computer systems including but not limited to Microsoft Office programs, Smartsheet and Salesforce.
• Experience with identifying risk related to drug development, timelines, budgets and compliance.
• Experience with application of risk management via FMEA (Failure Mode and Effects Analysis).
• Identify processes that would aide in streamlining workflow.
• Anticipate changes early by identifying factors that could impact the project. Develop contingency plans.

Travel Expectations

Travel required to manufacturing locations to host clients and site visits.