Manufacturing Specialist Lead

The Manufacturing Specialist Line Lead will play a part in the facility start-up with primary responsibilities focused on leading daily manufacturing activities on the floor, performing routine equipment, production, and line activities, and the timely production of pharmaceuticals.

Essential Duties and Responsibilities

• Led the day-to-day production activities on the line, responsible for aligning and scheduling personnel and resources to meet the daily and weekly production and equipment demands.
• Collaborate with Manufacturing, Quality Operations, Environmental Health and Safety, and other cross-functional teams to meet production needs.
• Support the onboarding and technical training of Manufacturing Operators on process equipment, including high-speed fill lines with integrated Isolators, Terminal Sterilizers, ATEC commodities processing, Parts Washers, Autoclaves, Single-Use Technology, and Aseptic Process Simulations (media fills).
• Assist R&D and MSAT on new product introduction and tech transfer activities to ensure a steady stream of products to meet commercial demand.
• Initiate and complete manufacturing investigations, including root cause analysis and product impact assessment.
• Assist in the revision and management of manufacturing documents such as Batch Records and SOPs.
• Provide technical expertise and support to production teams, addressing issues and challenges as they arise while working closely with Engineering and other support teams.
• Supports regulatory inspections.
• Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions to minimize impact on operations.

Basic Qualifications (Knowledge, skills, and abilities)

• A minimum of four+ years' experience in biopharmaceutical manufacturing in a GMP environment.
• An associate's degree or higher in Pharmaceutical Sciences, Biology, or a related field is preferred.

• Experience with sterile fill-finish manufacturing.
• Knowledge of GMP, regulatory requirements, and industry best practices.
• Detailed-oriented with a focus on accuracy in creating and updating production documents.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• Experience in a process improvement environment, including change management.
• Experience in using ERP systems.
• Strong communication and collaboration skills, committed to meeting high-quality standards.
• Experience performing as a shift lead of a team, training others, and developing training material.

Preferred Qualifications

• Knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).
• Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
• Proficiency in Microsoft Office Suite.