MCS Manufacturing Sr. Associate-MES/Validation

Job Summary:
The Senior Associate, Manufacturing will join the New Product Introduction (NPI) team. This role is crucial to managing the successful introduction of new products, with responsibilities spanning project management, change control ownership, and collaboration with cross-functional teams to support product launches and maintain compliance.

Key Responsibilities:

• Lead and manage New Product Introduction (NPI) and non-capital projects, ensuring successful project execution and compliance with GMP standards.
• Own change control processes, ensuring records meet regulatory standards with a "Right the First-Time" approach.
• Facilitate and ensure timely closure of change control records, following procedural guidance and timelines.
• Represent as the receiving site for new Technology Transfers and NPIs.
• Identify and advocate for improvement opportunities within the organization, building consensus to implement changes.
• Communicate clearly and succinctly in verbal and written formats, presenting records and business processes to staff, leadership, auditors, and inspectors.
• Participate in and lead Continuous Improvement Transformation initiatives to enhance processes and outcomes.
• Promote a culture of safety and compliance in all activities.

Day-to-Day Responsibilities:

• Manage and own Change Controls related to the introduction of new products Clinical and Commercial Drug Product Manufacturing facility.
• Initiate and lead continuous improvement projects to optimize production and quality processes.
• Ensure the on-time delivery and smooth integration of new products into the Manufacturing environment.

Top Skills & Qualifications:

• Project Management: Demonstrated expertise in project management, with experience leading cross-functional teams and managing complex initiatives.
• Team Collaboration: Strong ability to work in a team setting, fostering collaboration and accountability among team members.
• Attention to Detail & Quality Mindset: Ability to prioritize quality, ensure accuracy, and maintain detailed organizational practices.

Requirements

Basic Qualifications:

• Education/Experience:
• Master’s degree, or
• Bachelor’s degree with 2+ years of experience, or
• Associate’s degree with 6+ years of experience, or
• High school diploma/GED with 8+ years of experience.

Preferred Qualifications:

• Master’s degree or Bachelor’s degree with 2+ years of experience in a related field, such as life sciences or engineering.
• Experience with PAS-X Werum software for electronic batch records.
• Knowledge of Drug Product manufacturing operations, including buffer batching, formulation, filling, and inspection.
• Experience managing change controls in Trackwise.
• Proven technical writing skills with experience interacting with teams in Process Development, Process Engineering, Supply Chain, Quality Control, and Regulatory.

Shift:

• 5 days a week, 8 hours a day

• Overtime as needed