Lead Manufacturing Specialist
7 days ago
Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.
Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.
Department of Veteran's Affairs, the U.Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."
More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. 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 Civica Petersburg, 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.
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.
* 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.
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.
* Experience in a process improvement environment, including change management.
* 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.
Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
* Proficiency in Microsoft Office Suite.
Keywords: Manufacturing Technician, Location:
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