Jobs
>
Durham

    Manufacturing Manager - Durham, United States - Donaldson

    Donaldson
    Donaldson Durham, United States

    2 weeks ago

    Default job background
    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 IsoTagTM 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.

    www.isolerebio.comCombining 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:


    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 systemsEnsure necessary competencies and staffing are in place to delivery the facility start-up planCoordinate and supervise all production activities within Isolere's manufacturing facility, including hands-on execution as neededDevelop, 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 needsOversee the quality control process and ensure products meet specificationsDevelop and implement staff training for GMP manufacturing and maintain training records and complianceDevelop and implement strategies to improve efficiency, reduce costs, and increase productivityEnsure compliance with safety regulations and maintaining a safe workplace environmentAnalyze and report to leadership on key performance metrics and make recommendations for improvementImplement continuous improvement initiatives to streamline processes and maximize outputWork cross functionally with the product, development, and quality team to support tech transferDevelop plans to enable and manage the plant for manufacturing multiple productsSupport 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.


    Minimum Qualifications:
    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 schedulesBudgeting management, inventory management for manufacturingPreferred Qualifications:5+ years of experience in bioprocessing, pharmaceutical manufacturing, or FDA regulated reagent manufacturingExperience with microbial recombinant manufacturing of proteinsProven track record of starting up GMP operations aExperience with ERP such as Oracle or similar

    Experience in Lean methodologiesKey words:

    manufacturing, production, operations, management, cGMPEmployment 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.

  • Donaldson

    Manufacturing Manager

    6 days ago

    Donaldson Durham, United States

    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 an ...

  • Donaldson

    Manufacturing Manager

    1 week ago

    Donaldson Durham, United States

    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 an ...

  • Donaldson

    Manufacturing Manager

    2 weeks ago

    Donaldson Durham, United States

    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 an ...

  • Donaldson

    Manufacturing Manager

    1 week ago

    Donaldson Durham, United States Full time

    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 an ...

  • Mississippi Power

    Manufacturing Production Manager

    3 weeks ago

    Mississippi Power Durham, United States

    · Job Summary: · Leads production activities in various work centers (3 or more) in a way that ensures safety, quality, cost, and on time delivery goals are met. · Manages a group of Work Centers and disciplines, monitoring on-time and quality performance and promoting operati ...

  • bioMérieux SA

    Manager, Technical Manufacturing

    3 weeks ago

    bioMérieux SA Durham, United States

    Position Summary: · The Manager, TechnicalManufacturing position is responsible for Front-line leadership of their teams. · All Technical / Autonomous Maintenance aspects of reagent formulation, production/packaging inspecting, preventive maintenance, cleaning, troubleshooting an ...

  • National Black MBA Association

    Manager, GMP Manufacturing Support

    1 week ago

    National Black MBA Association Durham, United States

    Job Description Summary · The Manager, GMP Manufacturing Support, oversees and is responsible for the manufacturing cleaning program, pest control, gowning supply and finite scheduling program across the business. · This position is Monday-Friday 1st shift, overtime, on call and ...

  • Novartis Group Companies

    Manager, GMP Manufacturing Support

    1 week ago

    Novartis Group Companies Durham, United States

    Job Description Summary · The Manager, GMP Manufacturing Support, oversees and is responsible for the manufacturing cleaning program, pest control, gowning supply and finite scheduling program across the business. · This position is Monday-Friday 1st shift, overtime, on call an ...

  • Biogen

    Manager, Quality Assurance Biologics Manufacturing

    5 days ago

    Biogen Durham, United States

    About this role The Quality Assurance Manager Biologics Manufacturing is a fully onsite role responsible for strategic leadership of the Quality Factory Team for small and flexible volume manufacturing providing operational oversight of batch product Quality Assurance, Manufactur ...

  • Biogen

    Sr. Manager, Quality Assurance Biologics Manufacturing

    5 days ago

    Biogen Durham, United States

    About this role The Quality Assurance Sr Manager Biologics Manufacturing is a fully onsite role responsible for strategic leadership of the Quality Factory Team for large volume manufacturing providing operational oversight of batch production activi Quality Assurance, Manufactur ...

  • Actalent

    Associate Scientist

    1 week ago

    Actalent Durham, United States Full time

    Description: · The Associate Scientist position will work within the manufacturing team to execute viral vector production using (hands-on) both upstream and downstream operation activities for use in gene therapy applications. The Associate Scientist will also support in routine ...

  • Sig Sauer Inc

    Material Handler I

    1 week ago

    Sig Sauer Inc Durham, United States

    **Material Handler** · **2nd Shift** · SIG SAUER, Inc. is a leading provider and manufacturer of firearms, electro-optics, ammunition, airguns, suppressors, remote controlled weapons stations, and training. For over 250 years SIG SAUER, Inc. has evolved, and thrived, by blending ...

  • NovaWorks

    Aerospace Project Engineer

    3 weeks ago

    NovaWorks Durham, United States

    Job Description · What to expect in this role · Are you familiar with the topics of robotics and automation? · Our team in the Manufacturing Engineering department supports our client in the civil aviation industry with the implementation of projects in the areas of logistics, pr ...

  • Lilly

    Technician - Maintenance - Night Shift

    5 days ago

    Lilly Durham, United States

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve th ...

  • Wolfspeed

    Commodity Manager- Packaged Gases

    5 days ago

    Wolfspeed Durham, United States

    Commodity Manager - Packaged Gases · At Wolfspeed, we do amazing things in a human way. · We know that the achievements of our organization are due to the passion, hard work and creativity of our employees. We celebrate different perspectives to foster excellence across our organ ...

  • Horizon Controls Group

    HCG Technical Project Manager

    2 weeks ago

    Horizon Controls Group Durham, United States

    As the Technical Project Manager, you will be responsible for overseeing the planning, execution, and closing of a complex automation project installation within a pharmaceutical environment. The project will involve installing new automated systems. · Responsibilities · Develop ...

  • Accu-Fab

    Manufacturing Manager

    2 weeks ago

    Accu-Fab Raleigh, United States

    Job Description · Job Description · MANUFACTURING MANAGER - 1st Shift · Accu-Fab Manufacturing, a sheet metal manufacturing company in Raleigh, North Carolina, has an opening for a full time, 1st shift · MANUFACTURING MANAGER . This position reports to the Plant Manager and p ...

  • Pro Mach

    Manufacturing Manager

    3 weeks ago

    Pro Mach Raleigh, United States

    Do you enjoy hands-on work? Do you like solving puzzles? Are you motivated by seeing your contributions come to life? Our manufacturing team specializes in supporting the lifecycle of our machines and products. Our team is dedicated to consistency, fit, finish, machine integrity, ...

  • Pro Mach

    Manufacturing Manager

    2 weeks ago

    Pro Mach Raleigh, United States

    Do you enjoy hands-on work? Do you like solving puzzles? Are you motivated by seeing your contributions come to life? Our manufacturing team specializes in supporting the lifecycle of our machines and products. Our team is dedicated to consistency, fit, finish, machine integrity, ...

  • Wolfspeed

    Security Officer

    5 days ago

    Wolfspeed Durham, United States

    Security Officer (Day Shift) · At Wolfspeed, we do amazing things in a human way. · We know that the achievements of our organization are due to the passion, hard work and creativity of our employees. We celebrate different perspectives to foster excellence across our organizatio ...