Manufacturing Project Manager

Company Description

ABOUT LGC CLINICAL DIAGNOSTICS:

LGC Clinical Diagnostics develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics, and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials), the Native Antigen Company, which is a manufacturer and supplier of viral antigens and LGC Proficiency Testing a global leader in PT schemes. We operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), ISO 9001-accredited facility in Oxford, UK, and Traverse City, Michigan US.

Each day, our world-class staff, scientific expertise, operational efficiency, and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.

Job Description

In this role, you will coordinate manufacturing tasks and develop detailed manufacturing instructions outlining necessary raw materials, testing procedures, components, and resources. Your main responsibility will involve analyzing testing data from various platforms and troubleshooting issues to ensure accurate product manufacturing. You will serve as the expert on manufacturing products in production, such as panels, serological/NAT controls, bulk plasma, and urinalysis controls. Effective communication is key with customers, interested parties, team members, participants, partners, and team members to meet timelines and deliverables. You will oversee manufacturing design control and new product development tasks, identifying development needs and addressing any issues in the manufacturing or design process. You will demonstrate and inspire internal capabilities to meet customer requirements. You will act as the manufacturing Subject Matter Expert for New Product Development and new custom product opportunities. This role embodies LGC’s values of Passion, Curiosity, Brilliance, Integrity, and Respect, emphasizing strong work ethic, meeting requirements, and adherence to company policies and industry regulations. Qualifications Responsibilities

• Oversee day-to-day manufacturing product / product management, ensuring tasks are done according to standard operating procedures following cGMP and ISO 13485 quality systems.
• Align with all cGMP, ISO 9001 and/or ISO 13485 regulatory requirements (as per the site's regulatory status).
• Monitor and maintain stock inventory with planning used in all products to ensure availability.
• Provide technical guidance on new products, existing products, and panels.
• Participate in evaluating, developing, improving, or providing technical support for product manufacturing.
• Effectively collaborate to transition new products into Manufacturing, including developing relevant documentation.
• Collaborate with Marketing / Customers to define design goals and determine feasibility of custom products.
• Collaborate with the R&D Team to transition new products into Manufacturing.
• Work with QC Team to ensure product testing is up to date, assist with crossover studies when required.
• Communicate technical aspects of LGC products to support internal and external customers.
• Lead troubleshooting investigations to resolution for any manufacturing area/customer complaint with little or no assistance.
• Act as a liaison for technical communication with custom product team and manufacturing.
• Maintain working knowledge of urinalysis, toxicology, and infectious diseases; pursue continuous education for the expansion of product lines.
• Maintain all product testing data, metrics for the department; track and report as required.
• Travel required on an as-needed basis.

Qualifications

Minimum Qualifications:

• Bachelor’s degree or equivalent experience (minimum of 5 years), with a focus on Biology, Chemistry, or a related scientific field.
• Experienced in a Life Science setting, with a background in cGMP/ISO conditions, involving clean rooms within a manufacturing department capacity for over 5 years.