Project Coordinator

SUMMARY:
As an Associate Manufacturing Coordinator within Drug Product Supply, you will play an integral part in supporting operation aspects of internally manufactured clinical supplies.
This position will provide project management experience for clinical and developmental manufactures of solid dosage forms (eg, tablets, capsules).
Primary responsibility in the coordination of manufacturing campaigns will include creation of batch records and supporting documents, enabling tech transfer from partner lines, overseeing material movement with Inventory Management group, and providing customers and support groups with Real Time project status reports.
The candidate will also develop and deploy technology solutions and workflows to improve internal operations, knowledge capture, and manufacturing process understanding.

PROJECT MANAGEMENT/MANUFACTURING COORDINATION:
Assist project lead in the coordination of GMP manufacture of drug product internally
Create Batch documentation and oversee the review and approval processes.
Coordinate activities with partner lines to ensure smooth tech transfer, procurement and movement of materials, delivery of needed documents towards timelines, and timely product testing and disposition.
May involve troubleshooting of technical and quality/compliance issues and ensuring timely resolution.

CUSTOMER SERVICE/TEAMWORK/LEADERSHIP:
Work closely with partner lines (eg, Supply Chain Leaders, Drug Product Design Formulators, Drug Product Master Planner, and other Pharmaceutical Science colleagues) to define, develop, and execute project plans for drug product deliverables across the Human Health portfolio.
Provide customers and support groups with Real Time project status reports.
Demonstrate good interpersonal, organizational and communication skills (both oral and written)
Able to multi-task and work effectively in a Matrix team.

TECHNOLOGY, PROCESS, AND METRICS:
Support and enhance team SharePoint site
Utilize internal IT systems to manage workflow and maintain/track metrics.
Design, develop and deploy database management solutions to capture key process learnings and data
Proactively assess and interpret business needs to propose innovative solutions.

SKILLS:

QUALIFICATIONS:
Bachelors/Masters degree in a relevant Scientific or Engineering discipline (Chemistry, Engineering, Pharmacy or other relevant science or engineering degree). Experience working in the pharmaceutical industry is a plus.
Preferred work experience would include any of the following: drug product clinical supply or pharmaceutical development, formulation development, sourcing and supplier management, project management, pharmaceutical manufacturing
Strong skills in the use of technology solutions and database management (proficiency in HTML is a plus)
Excellent communication and organizational skills.
Self-motivated and adept at regularly delivering towards timelines.
Strong skills in troubleshooting.
Knowledge of industry practice for cGMP.