Our client, a well-known, fast-growing manufacturer of Immunohistochemistry products seeks a Production Manager to head up a new facility.
Position Summary:
The company is looking to grow capabilities at their facility to include regulated immunohistochemistry products. As the production manager, you will be responsible for setting up the workflow and a production team to produce IHC antibodies that are used in research, as well as certified as IVD and ASR products. The initial portfolio will be transferred from another location, but new products will be continued to be added on a regular basis. This person will ensure that products in the IHC workspace are manufactured with the highest level of quality and compliance in a safe and timely manner that will meet customer expectations. The position is responsible for developing and managing a high performing team while driving results.
Key Responsibilities:
- Set up IHC workflow and production team to produce RUO, IVD, and ASR antibodies. This includes all process and method validations including the technical transfer.
- Ensure production goals are achieved and assure production and laboratory standards are in compliance with all safety, GMP, ISO, and other regulatory and company manufacturing guidelines.
- Direct the team to develop products according to design specifications and develop and validate testing methods relevant to the product
- Responsible for meeting key project milestones and driving productivity
- Should liaison with cross functional teams to achieve project goals
- Listens, supports, engages and encourages employee suggestions and input to achieve excellent results while driving a culture of accountability.
- Monitors, reviews, and improves manufacturing and quality related activities and drives investigations and corrective and preventative actions.
- Collaborate with internal and external stakeholders to provide outstanding service in line with their expectations.
Minimum Requirements/Qualifications:
- Degree in any Life Science or Chemistry.
- A minimum of 3 to 5 years of industry experience specifically related to IHC, Western Blotting, or other life science process.
- Experience working in cross functional projects and/or experience in managing contract research projects
- Good understanding and ability to adhere to established quality standards and regulatory compliance requirements for medical device or diagnostics will be a plus
- Experience with supervision and managing a team
- Track record of achieving results and proven ability to clearly identify and communicate a cogent vision; effectively manage through ambiguity and uncertainty, take appropriate risks and make sound and timely decisions.
- Excellent communication, executive presentation, and leadership skills with a collaborative approach to problem solving
- Ability to lead, motivate and influence others.
- Superior organizational skills with ability to multi-task and balance complex and routine work activities.
Desired:
- Extensive previous experience in immunohistochemistry, diagnostic manufacturing environment with through knowledge reagent manufacturing activities.