MCS Manufacturing Sr. Associate

Summary: At BioPharma Consulting JAD Group, we are seeking a motivated MCS Manufacturing Sr. Associate to join our Team. As a Senior Associate, you will be responsible for supporting manufacturing operations and leading continuous improvement initiatives. You will collaborate with cross-functional teams to ensure quality, safety, and compliance in all manufacturing processes.

Responsibilities:

• Provide subject-matter expertise for drug substance upstream and downstream processes as a Single-Use SME.
• Lead complex projects or project components using advanced project management skills.
• Quickly resolve issues and execute function tests to troubleshoot and optimize processes.
• Write protocols and reports for validation, function testing, equipment commissioning and qualification, and change management.
• Work various shifts, including day, swing, graveyard, weekends, and holidays, as required by the production schedule to minimize disruptions to operations.
• Perform work in a cleanroom environment, adhering to GMP documents (SOPs) and safety and compliance protocols, while wearing appropriate cleanroom attire.
• Apply technical, scientific, operational, and compliance knowledge to support the implementation of new technologies in the plant.
• Demonstrate strategic problem-solving skills and advocate for continuous improvement.
• Support new product introduction and projects through Single Use Systems (SUS) mapping.
• Perform troubleshooting on the manufacturing floor, initiate investigations, and manage the SUS defect/leak triage process.
• Initiate and follow through on EN/SICAR records, working with vendors on investigations.
• Maintain up-to-date EN/SICAR/EE trackers and manage or lead small to medium-sized projects.
• Manage change control processes for new product introductions and process improvements.
• Lead and support diverse projects, utilizing project management methodologies.

Preferred Qualifications:

• Technical knowledge of drug substance processing and a broad understanding of related disciplines.
• Excellent communication skills, both written and oral, with the ability to present complex technical information to various organizational levels.
• Ability to coach, mentor, and cross-train colleagues.
• Strong team player with the ability to support and reprioritize tasks as needed.
• Proven leadership skills in managing cross-functional teams and driving project results.
• Expertise in SUS technologies.
• Proficiency in data analysis and visualization tools.
• Proficiency in Smartsheet, Excel, Trackwise, Visio, PI, SAP, and Spotfire.

Requirements

Qualifications:

• Master’s degree in Engineering or Life Sciences, and 2 years of experience OR
• Bachelor’s degree in Engineering or Life Sciences and 2 years of experience OR
• Associate’s degree and 6 years of experience OR
• High school diploma/GED and 8 years of experience