Senior Project Manager, API Coordination
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Job Location:
North Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
15 days ago
Vacancies:
1 Vacancy
Job Summary
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 :
- Bachelors 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 or local law:
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.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable 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 visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Business Development
- Project Management Methodology
- Project / Program Management
- PMBOK
- Waterfall
- Wastewater
- Construction Management
- Project Management
- Project Management Software
- Microsoft Project
- Budgeting
- Contracts
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
