Senior Project Manager, API Coordination

Project Manager For Clinical Trials And Manufacturing

Responsible for the project management and planning of manufacturing and supply chain activities for products used in phase I-III clinical trials and drug development manufacturing. This is accomplished by interacting with project representatives from multiple cross-functional groups including API development teams, formulation, analytical, QA and other R&D manufacturing sites worldwide.

• Develop supply chain and operational strategies to assure the pilot plant and project teams meet API and/or drug product delivery requirements. Identify any conflicts and resolve issues that may impact the schedule, including issues related to quality, safety, material or equipment availability.
• Responsible for identifying project specific requirements, such as special commodity needs, packaging and lot distribution requirements and assures all factors are ready for manufacturing start.
• Responsible for raw material and commodity sourcing of pilot plant programs.
• Manage external manufacturing programs for resupply campaigns, as needed. Coordinate with third party manufacturers to support manufacturing campaigns and manage process orders and shipping.
• Collaborates with the materials manager, program manager, and/or team lead to set expectations for procurement needs. Identifies significant changes in forecast volumes or deliveries that may require a change in purchasing strategy or adjustment in manufacturing timelines and drives any gaps to resolution.
• Collaborates with project teams and commercial operations during product tech transfer to establish expectations and set strategies for material transfers and deliveries.
• Responsible for the SAP production planning for his/her assigned projects. This includes BOM maintenance, master recipes and issuing process orders or equivalent to the warehouse for staging and to manufacturing for production.
• Tracks and communicates project timelines, activities and logistics. Generates metrics for area KPI reviews.
• Lead process improvement initiatives to streamline supply chain and operational activities for the pilot plant.
• Participates in cross functional initiatives, as needed.

Key Stakeholders:

Project team members from development, analytical, CMC and QA Coordinators from other Operations/sites Supply Chain and tech transfer teams from other Operations sites Purchasing

Qualifications:

• Bachelor's degree required.
• Minimum experience: 5+ years total in the pharmaceutical industry.
• Must have experience in one of the following areas: Drug development (e.g. process chemistry, formulation, etc.), Manufacturing Operations, Supply Chain or Quality Assurance.
• Must have understanding of importance of compliance in a regulated environment.
• Ability to work collaboratively across departments/functions and interact in a tactful, professional manner.
• Ability to manage and prioritize multiple tasks under tight deadlines and high pressure.
• Strong problem solving and project management skills.
• Strong communication skills (both written and oral).

Additional Information:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.