Shift Lead (Crosslink): 2nd Shift M-F 10am-6:30pm

Anika Therapeutics•Bedford, MA

13h•Onsite

About The Position

The Shift Lead is responsible for overseeing day-to-day floor operations. The Shift Lead is a role model with safety, quality and cGMP and is the primary technical resource for ensuring scheduled operations are completed as planned and maintaining quality standards on the manufacturing floor. This role ensures effective utilization of shift personnel, materials, and equipment, to produce high-quality products that meet on time customer delivery requirements and internal performance objectives.

Requirements

Bachelor’s degree in a technical discipline (Engineering, Chemistry, Manufacturing) or equivalent experience is preferred.
Minimum 6 years of experience in cGMP manufacturing.
At least 3 years of experience with Material Requirement Planning (MRP) systems, including routine material transactions and production planning.
Minimum 2 years of experience in cGMP-regulated pharmaceutical or medical device manufacturing in a Lead role, demonstrating the ability to guide, train, or mentor operators.
Strong working knowledge of FDA, ISO, and other applicable quality system regulations.
Ability to work flexible hours to complete work activities.
Must possess good written and verbal communication skills.

Nice To Haves

Experience supporting internal quality inspections/audits.
Experience working in a clean room or using aseptic technique
Experience using SAP or similar ERP systems for MRP transactions and manufacturing reports.
Proficient in Microsoft Office (Excel, Word, Outlook, PowerPoint).
Strong organizational skills and the ability to work independently.

Responsibilities

Provide direct floor leadership for all assigned staff members in crosslink manufacturing during shift hours.
Optimize labor and equipment resources to maintain shift productivity and compliance.
Coordinate XLHA and formulation activities with Area supervisor and create a daily plan to execute all crosslink operations.
Delegate daily manufacturing operations including organic synthesis, purification, dissolutions, formulation, filling, and sterilization of syringes in cleanroom environment.
Assign work to shift members and resolve day-to-day production issues in real time.
Collaborate with Technical Leads and Engineering to ensure on-time delivery and compliance with the production schedule.
Ensure timely and accurate completion of all MRP-related manufacturing transactions for all product lines.
Maintain compliance with FDA cGMP, ISO, OSHA, and EPA regulations across all operations.
Review and approve GMP documentation for accuracy and completeness prior to quality submission.
Manage staff breaks and responsibilities.
Ensure documentation is complete, reviewed, and meets good documentation practices (Forms, Logbooks, Batch Records, etc.).
Initiate deviations or investigations and work with cross functional departments to identify root causes.
Responsible for floor inventory and communicating production schedule changes to shift members.
Monitor material consumption and coordinate all preparation.
Perform required real time ERP transactions affiliated with material receipt or consumption.
Ensure work is conducted in a safe manner, notifying management of safety issues and risks.
Act as subject matter expert for all critical processes within department by performing critical steps when needed and performing full skill development training to junior staff.
Assist with identifying training needs, conduct skills development training and provide feedback to supervisor or manager.
Perform other duties and projects as assigned.
Provide on shift leadership and direction to team members, ensuring smooth daily operations.
Assign tasks, monitor performance, and offer real-time coaching and support.
Serve as the primary point of contact for staff during assigned shifts and escalate issues to the area supervisor / management as needed.
Oversee workflow, break schedules, and adherence to company policies while on duty.