Sr. Project Manager - Clinical/Commercial Packaging, GMP, Drug Product

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?

Job Summary

The Senior Project Manager will coordinate a multidisciplinary project team to assure the accurate and timely completion of all contract writing and managing, ERP, invoicing, designing and implementing project plans, acting as the primary liaison with the project team and client communicating project information to appropriate staff members. The Senior Project Manager may serve as program manager and assist clients with their drug development programs. The Senior Project Manager may also be called upon to participate in the corporate management process and shall actively engage in and support business development efforts.

On-Site Expectations

• Hybrid role with up to 70% expected on-site, depending on project requirements.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Develops and tracks the project development plan using Smartsheet.
• Identifies and tracks critical path/activities, risks, contingencies and alternatives.
• Communicates out-of-scope activities both internally and externally.
• Implements Change Orders.
• Facilitates team meetings with client and project team; setting-up sub-team meetings as necessary.
• Drives strong interdepartmental collaborations to drive task completion and maintain project timelines.
• Develop a strategy and work with project teams and clients to manage their contract needs.
• Develop and approve proposals and contracts for assigned clients and projects in conjunction with the appropriate project team members.
• Manage contract requirements for each assigned project through ERP and project teams.
• Communicate budget requirements and status to all team members for each assigned project.
• Design, implement timelines, and coordinate a detailed project operational plan for each assigned project.
• Provide project status information both internally and externally at strategic level.
• Provide input and feedback to Senior Management, Line Manager, or individual team members performance.
• Provide direct supervision of Associate Project Manager(s) and Project Managers specific to projects assigned to them.
• Serve as proxy for the management of project managers as needed.
• Assist with business development efforts through ongoing contact with new and assigned clients.
• Assist with regulatory preparation, submission and overseeing project teams within the program.
• Other duties as assigned.

Qualifications

• BA/BS in related field with 5-8+ years pharmaceutical experience.
• Must have 5 years Project Management experience managing multi-disciplinary project teams.
• FDA regulation/ICH Guidelines.
• U.S. Drug Development process.
• Project Management Operations.
• Budgets.
• ERP, QMS, CRM, and MS Suite.

Knowledge, Skills, and Abilities

• Computer proficient.
• SAP experience a plus.
• Master Control experience a plus.
• Inventory Management (i.e. procurement, supply chain) experience a plus.
• Communication (verbal and written) and presentation skills.
• Excellent organizational skills.
• Ability to multi-task.
• Strong negotiation skills.
• Presentation skills.
• Leadership skills.
• Mentoring skills.

Travel Expectations

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

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, you will regularly be required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

The noise level in the work environment is usually quiet with periods of higher noise elevations when present in warehouse or manufacturing areas. The employee may be required to gain access to lab personnel via general lab or manufacturing areas only for work discussions or follow-up or be required to tour clients through the various facilities. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.