Manufacturing Technical Manager

Job Description

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 VA 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

• 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)

Preferred Qualifications