- Facility readiness and start-up plan: ensure that all necessary elements are in place for GMP production of Isolere products, including CMC, supply chain, and maintenance systems
- Ensure necessary competencies and staffing are in place to delivery the facility start-up plan
- Coordinate and supervise all production activities within Isolere's manufacturing facility, including hands-on execution as needed
- Develop, manage, and facilitate the production planning and the production schedule to ensure timely delivery of product to support inventory maintenance, customer needs, and R&D team needs
- Oversee the quality control process and ensure products meet specifications
- Develop and implement staff training for GMP manufacturing and maintain training records and compliance
- Develop and implement strategies to improve efficiency, reduce costs, and increase productivity
- Ensure compliance with safety regulations and maintaining a safe workplace environment
- Analyze and report to leadership on key performance metrics and make recommendations for improvement
- Implement continuous improvement initiatives to streamline processes and maximize output
- Work cross functionally with the product, development, and quality team to support tech transfer
- Develop plans to enable and manage the plant for manufacturing multiple products
- Support the operational function for the site including equipment, supply chain, purchasing, planning, environmental health and safety (EHS), project management, logistics, and project management.
- In partnership with the facilities manager, you will be responsible for the site operations functions in the plant for all shifts to ensure on-time production and shipment of high-quality product and facilitating site R&D activities.
- In partnership with facilities and R&D leadership, oversees functions including purchasing, inventory management, planning the production flow, troubleshooting manufacturing issues, supporting staff, and effectively managing daily capacity to meet schedule requirements.
- Other tasks and assignments as required to meet business objectives.
- In partnership with R&D and facilities leadership, develop new and improved manufacturing processes needed to launch new product and maintain a competitive advantage in the marketplace.
- Develop and maintain a high-performing employee environment and develop team members to ensure they feel encouraged and motivated to contribute to their full potential.
- Bachelor's degree in science or engineering, or another related field.
- Hands-on experience in manufacturing operations, such as working as a supervisor or team leader.
- Minimum 2 years of leadership experience in a highly regulated, preferably cGMP (FDA) manufacturing environment, including managerial or supervisory experience or a combination of education and experiences.
- Experience in management of production planning and schedules
- Budgeting management, inventory management for manufacturing
- 5+ years of experience in bioprocessing, pharmaceutical manufacturing, or FDA regulated reagent manufacturing
- Experience with microbial recombinant manufacturing of proteins
- Proven track record of starting up GMP operations a
- Experience with ERP such as Oracle or similar.
- Experience in Lean methodologies
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Manufacturing Manager - Durham, United States - Donaldson
Description
Donaldson is committed to solving the world's most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration and innovation that matters and a chance to learn, effect change, and make meaningful contributions at work and in communities.
Isolere Bio, Inc. located in Research Triangle Park, NC, is one of Donaldson's latest addition to a growing list of biotechnology initiatives. Isolere Bio develops reagents that combine engineered biopolymers with tunable phase separation, with affinity ligands that confer the unique material properties to the biologic target of interest. The company offers a growing portfolio of purification solutions for a wide range of biologics, including AAV, lentivirus, mRNA, plasmid DNA and other viral particles. This portfolio of IsoTag reagents are first of their kind and will catalyze a paradigm shift in bioprocessing. They offer significant competitive advantages - improving productivity and quality while reducing the overall cost of goods for increasingly complex biologic drugs.
Combining Isolere's deep expertise in liquid phase separation, and Donaldson's filtration technology expertise, and global sales and manufacturing footprint, we are on a fast-track to develop and commercialize Isolere's novel affinity liquid phase separation reagents for biologics purification.
The Manufacturing Manager will play a crucial role in driving the growth and success of Isolere as we build out our manufacturing capabilities to support commercial growth. The successful candidate will be responsible for the overall manufacturing execution for the Isolere Facility in Research Triangle Park, North Carolina. They will provide leadership and support to a team focused on the development and manufacturing of novel affinity purification products, drive day to day site operations, and ensure the Safety, Quality, Delivery and Cost of our products and processes.
Due to the early nature of Isolere's products, a great candidate will have an entrepreneurial mindset while still being able to navigate the established, supporting corporate culture of Donaldson and contribute to its growing life sciences vertical.
Role Responsibilities:
Minimum Qualifications:
Preferred Qualifications:
Key words: manufacturing, production, operations, management, cGMP
Employment opportunities for positions in the United States may require use of information which is subject to the export control regulations of the United States. Hiring decisions for such positions are required by law to be made in compliance with these regulations. Applicants for employment opportunities in other countries must be able to meet the comparable export control requirements of that country and of the United States.
Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
Manufacturing Manager professionals in Durham
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James DeCarlo
Permanent or contract Validation Engineer.