Senior Project Manager, API Coordination

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

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.
  
  
  

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).
  
  
  

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

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible to participate in our short-term incentiveprograms.
  
  
  

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

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.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html