Manufacturing Specialist (weekend day shift)

Role Summary

This on-site role is located in Indianapolis, IN. The Manufacturing Specialist on the Weekend Days shift provides front line support to manufacturing, ensuring each batch is produced safely and in compliance with instructions and quality requirements. You will act as the Subject Matter Expert for product and process knowledge, serving as the first point of contact for product-related issues and driving investigations to root cause and corrective actions.

Responsibilities

• Manage and maintain manufacturing documentation including Master Batch Records, SOPs, risk assessments, protocols, and related documentation.
• Technical writing and reviewing to support manufacturing operations including SOPs, batch records, and white papers.
• Collect data for ongoing process verification, support tracking and evaluation of product performance, and implement CAPAs.
• Authoring/owning investigations related to material transfer, isotope manufacturing, and packaging.
• Ensure processes remain inspection ready at all times.
• Support process optimization and new technology introduction for productivity improvement.
• Review validation protocols and reports; support execution of process validations and short-term improvement projects.
• Provide guidance and training to production teams and share knowledge.
• Demonstrate leadership capabilities and guide processes to closure while following guidelines and procedures.
• Participate in assigned qualification/validation activities as necessary.
• Foster a culture of speaking up and ensure adherence to cGMP compliance activities.
• Prepare documents and records such as batch records, shipping documents, and training materials.
• Participate in periodic mandatory overtime to ensure process continuity and completion.
• Other duties as assigned.
• Maintain overall inspection readiness for the area of responsibility and report technical complaints/adverse events within 24 hours; handle distribution of marketing samples where applicable.

Qualifications

• Required: Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or relevant experience in lieu of degree.
• Preferred: Training in radiochemistry or radiopharmacy.
• Required: 3+ years’ experience in a process support shop floor role in GMP manufacturing and/or QA/QC.
• Required: Strong awareness of quality issues; experience with compliance investigations.
• Required: Good understanding of manufacturing and validation requirements and activities.
• Required: Ability to leverage new technology and techniques to eliminate non-value-adding activities and improve productivity through new processes.
• Required: Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
• Required: Proficient in MS Office applications.