MCS Manufacturing Sr. Associate

The MCS Manufacturing Sr. Associate at BioPharma Consulting JAD Group is an integral role that contributes to the successful launch and management of new drugs in a cutting-edge manufacturing facility. The ideal candidate will be responsible for overseeing the Change Control process, managing project timelines, and ensuring adherence to both quality and compliance standards in the manufacturing environment.

Key Responsibilities

• Lead and manage New Product Introduction (NPI) projects and non-capital initiatives.
• Serve as the change control owner, ensuring GMP-compliant records and timely closure in line with procedural guidelines.
• Act as the primary contact for incoming Technology Transfers/New Product Introductions into Building 20.
• Identify and drive process improvements within the organization, building consensus for implementation.
• Collaborate cross-functionally with Manufacturing, Quality Assurance, Process Development, Analytical Sciences, Regulatory Affairs, and other departments.
• Communicate clearly and effectively, both verbally and in writing, with staff, leadership, and external partners.
• Present records and processes to internal and external audiences, including auditors and inspectors.
• Lead or participate in Continuous Improvement Transformation activities to optimize operations.
• Champion safety and compliance in all aspects of manufacturing and project management.

Top 3 Must-Have Skills

1. Project Management: Strong organizational and leadership skills in managing NPI and change control projects.
2. Team Player: Ability to collaborate across departments and lead cross-functional teams.
3. Attention to Detail/Quality Mindset: Commitment to compliance and quality standards, with a focus on "Right the First Time" results.

Day-to-Day Responsibilities

• Own and manage change controls for the introduction of new products into Building 20.
• Initiate and manage continuous improvement projects.
• Ensure timely delivery of new product introductions to support clinical and commercial manufacturing operations.
• Prepare and present project updates, ensuring clear communication with all stakeholders.

Requirements

Basic Qualifications

• Master’s degree OR
• Bachelor’s degree with 2 years of experience OR
• Associate degree with 6 years of experience OR
• High school diploma/GED with 8 years of experience

Preferred Qualifications

• Master’s degree in life sciences or engineering.
• Experience with PAS-X Werum software for electronic batch records.
• Technical understanding of Drug Product (DP) manufacturing processes such as buffer batching, formulation, filling, and inspection.
• Experience leading change controls using TrackWise.
• Demonstrated technical writing skills and the ability to collaborate with Process Development, Supply Chain, and Quality Control teams.
• Prior experience managing projects in a regulated manufacturing environment.