Project Manager

Project Manager (All Levels)

Summary of Role
The Project Manager is an essential partner with the Operations and the site leadership team and is accountable for driving results in a dynamic environment by driving projects to completion. The Project Manager has a strong scientific and technical understanding of Sterling 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 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. The position requires superior leadership behaviors of the Sterling core competencies and non-negotiables, as well as expertise in functional competencies included in this profile. In addition, this role requires the 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 Sterling 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 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 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 project(s).
• 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 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.
• An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

Key Competencies

• Technical and scientific knowledge and understanding of Sterling 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 Sterling customers.
• Ability to organize and run business/project review meetings with a joint steering committee comprised of senior leaders representing Sterling and the customer. Ability to answer impromptu questions and provide real-time updates.
• Ability to drive successful resolution when conflict arises between Sterling and customer timelines, either by challenging and influencing the project team to adjust their course of action or to advocate for Sterling'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.
• Excellent verbal and written communication and presentation skills.
• Ability to motivate and influence others.
• Proficient in computer systems including Microsoft Office programs.
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
• Duties, responsibilities and activities may change at any time with or without notice.

Education and Experience
All Levels

• Bachelor's degree in a scientific discipline required. Master's degree preferred.
• Pharmaceutical or biotech experience required.
• CMO or CDMO experience preferred.
• Prior experience in a customer-facing role required.
• Formal project management training or certification preferred.

Level I

• 3 years of related pharmaceutical or biotech experience required.
• 2 years of experience leading multi-disciplinary project teams in a service business required.

Level II

• 5 years of related pharmaceutical or biotech experience required.
• 3 years of experience leading multi-disciplinary project teams in a service business required.

Senior

• 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.

Travel Requirement

• Up to 10% travel required.

Diversity and Inclusion:
Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.