Project Manager/Senior Project Manager - API

Aaipharma Germantown , WI 53022

Posted 5 months ago

Position Summary:

The Project Manager/Senior Project Manager for API development and manufacturing is an essential partner with the Operations and the site leadership team, and is accountable for driving results in a dynamic environment. The Project Manager 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 leads cross functional project teams to deliver against contracted commitments and timelines. The Project Manager must have in depth 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. 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. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies including ability to lead and influence multi-disciplinary project teams meeting standards in a GMP environment, and demonstrated skills and abilities in critical thinking, problem solving, detail and results orientation, managing multiple and sometimes competing priorities and excellent verbal and written communication.

Essential Functions

  • 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 to the Sales and Business Development Manager 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 time frames 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 using MS Project, open actions using MS Excel, monitors forecasted revenue using the AX system, 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 projects.

  • Works closely with the Sales and Business Development Manager to generate change orders and 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 the 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.

Education and Experience

Project Manager

  • Bachelor's degree in a scientific discipline required. Master's degree preferred.

  • Pharmaceutical or biotech experience required. API experience preferred.

  • CMO or CDMO experience preferred.

  • Prior experience in a customer-facing role required.

  • Formal project management training or certification preferred.

  • 3 years of related pharmaceutical or biotech experience required. 5+ years preferred

  • 2 years of experience leading multi-disciplinary project teams in a service business required. 3+ years preferred.

Senior Project Manager

  • Bachelor's degree in a scientific discipline required. Master's degree preferred.

  • Pharmaceutical or biotech experience required. API experienced preferred.

  • CMO or CDMO experience preferred.

  • Prior experience in a customer-facing role required.

  • Formal project management training or certification preferred.

  • 8 years of related pharmaceutical or biotech experience required.

  • 5 years of experience leading multi-disciplinary project teams in a service business required.

  • Ability to independently manage projects of any size, scope and complexity.

  • Ability to coach and provide direction to less experienced project managers.

Alcami Non-Negotiables

  • Consistently demonstrates honesty and integrity through personal example.

  • Follows all safety policies and leads by example a safety first culture.

  • Produces high quality work product with a focus on first time right.

  • Complies with the company code of conduct and policies and regulatory standards.

Alcami Core Leadership Competencies

  • Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.

  • Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.

  • Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.

  • Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.

  • Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.

  • Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.

Functional Competencies

  • 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 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.

Travel Requirements

  • Up to 10% travel required.

What We Offer You:

  • Competitive salary with career advancement opportunities.

  • Profit sharing bonus plan.

  • Medical, dental and vision coverage from day one.

  • 401(k) with company match.

  • Company paid vacation, holiday and sick-leave.

  • Voluntary benefits including short & long term disability, life, accident, critical illness insurances.

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Project Manager/Senior Project Manager - API