Job Description

Position Summary

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 at the site. In collaboration with stakeholders, this position will support cross-functional teams with manufacturing production execution, running equipment, new product introductions, equipment qualifications, investigations, training, and development of new colleagues and line personnel. The ideal candidate will have a consistent track record of achieving results in a fast-paced, sterile manufacturing environment and maintaining a positive culture.

Essential Duties and Responsibilities

• Lead 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 4+ 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.

Physical Demands and Work Environment:

The physical demands described here represent those that an employee must meet to perform the essential functions of this position successfully. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions. While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee must frequently use hands or fingers to handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate.

The company is an equal opportunity employer, a drug-free workplace, and complies with applicable ADA regulations.

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