Job Description

Job Summary

Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

The manufacturing manager is responsible for the manufacture of immunoassay in-vitro diagnostic kits. Tasks include the development, implementation and maintenance of manufacturing documents, processes and activities that are compliant with cGMP best practices. Strong communication, leadership and organizational skills are essential. A comprehensive understanding of the entire manufacturing process of immunoassays (antibody production through final kit release testing and assembly) is crucial. The objective is to assure on-time delivery of product that meets quality standards and that manufacturing processes comply with corporate and global standards.

Principal Duties and Responsibilities

* Manage employees and other resources (facility, equipment, materials) to meet all production demands and manufacturing activities
* Maintain active BOMs for each product
* Generating, reviewing, and approving documents, including standard operating procedures, batch records, material specifications, testing results and validation protocols/ reports
* Ensure processes, documents, materials, and equipment follow applicable regulatory requirements including ISO13485, ISO 14971, cGMP and cGLP for testing
* Ensure training curricula and employee training is current
* Participate in investigations related to Nonconformance and/or Corrective and Preventive Actions related to manufacturing.
* Participate in investigations related to Product Complaints.
* Oversee design transfer from R&D to Manufacturing
* Oversee the generation, maintenance, and coordination of the Master Validation Plan.
* Oversee the process validation related activities for the design, qualification, and continued process verification of manufacturing process, including identification of opportunities for improvement.
* Work closely with QA to maintain compliance
* Support regulatory submissions as they relate to manufacturing activities
* Identify and mitigate risks in manufacturing operations that could negatively impact delivery of safe and effective products to patients
* Ensure deviations, CAPA, change controls, process transfers, and pFMEAs are supported
* Maintains a safe, clean work environment

This is not an exhaustive list of duties or functions and may not necessarily comprise all the essential functions for purposes of the ADA.

Expected Areas of Competence

* Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions
* SME (Subject Matter Expert) in immunoassays for in vitro diagnostics assays
* Creative thinking and problem-solving skills to continually improve the manufacturing process
* Utilize leadership and motivational skills to expedite completion of critical project tasks with other functional groups
* Establishes manufacturing methods which meets performance and quality requirements
* Strong project management skills with the ability to coach, develop, and manage staff
* Proficiency with using Microsoft Office Suite
* Demonstrated ability to learn and apply multiple skill sets determined by areas of responsibilities
* Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Education/Experience Requirements

* Minimum B.S. in Biological Sciences, biomedical Engineering, or related field
* Minimum 10 years of progressive experience in manufacturing engineering, operations or related field, or an equivalent combination of education and experience
* Supervision/Management experience required
* Immunoassay experience required
* In-vitro diagnostic experience preferred
* JDE or similar MRP experience needed

Travel Requirements

* Occasional off-site training/meetings

Additional Information

EOE/M/F/Vet/Disability

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.