Senior Manufacturing Manager Jobs

Basic Qualifications (Required Skills / Experience):

Acquires resources for department activities, provides technical management of suppliers and leads process improvements.

Manages employees and first-level managers performing activities within multiple manufacturing disciplines.

Manages, develops and motivates employees and first-level managers.

3+ years of experience in a manufacturing environment

5+ years of experience developing and driving diversity strategies with leadership teams

Business unit experience with emphasis on product costing and inventory management at a global semiconductor company.

Bachelor’s degree in Finance, Accounting or Economics (or equivalent experience). MBA and/or advanced Accounting or Finance a plus.

Advanced proficiency with excel. Experience with SAP, Power BI, Tableau or other finance applications or visualization tools a plus.

Advanced technology skills and experience with visualization tools a plus, SQL, Power BI, Tableau.

General understanding of inventory manufacturing, supply chain and operational flows and processes. Semiconductor experience a plus.

Experience in redefining systems and processes, with the ability to influence within all levels of company.

BS in Manufacturing/Industrial Engineering and 8+ years experience in quality assurance management or equivalent field.

Partner with the Engineering Director and Production Manager to ensure products are meeting requirements. relentlessly to improve product and processes.

Experience with quality systems, certification and controls.

Working knowledge of Solidworks, productivity software, and strong communication skills.

Manage and develop the Manufacturing Quality team.

Strong knowledge of manufacturing best practices, including Lean Manufacturing principles.

Strong project and time management skills, attention to detail

Collaborate cross-functionally with product management, engineering, design, and marketing to ensure a smooth development process

Support the management team with effective team communication, proactive problem solving, information distribution – present to different levels within the organization

Experience in operations-led transformation, preferably in a start-up environment

8+ years of relevant experience

Exceptional verbal, written, and interpersonal communications skills

Expertise in Design of Experiment and working knowledge of Process Control Metrics and measurement.

Solid understanding of, and experience deploying, lean principles in a production environment.

Experience specifying and implementing measurement and metrology tools in a manufacturing environment.

Experience leveraging Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5 to ensure effective assembly of complex hardware.

Experience with design for manufacture for CNC Machining, sheet metal fabrication, and structural steel framing.

Experience implementing Poka-Yoke (Error Proofing), and PFMEA (Process Failure Mode and Effects Analysis).

Implementing operating manufacturing systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.

Demonstrated track record supporting commercial licensure of CAR T products. International experience preferred.

Knowledge of Lean Manufacturing principles required.

Advanced understanding and experience with CAR T manufacturing including cell culture, cryopreservation, purification, filling, and aseptic processing.

Experience with reviewing and approving SOPs, Batch Records, Change Controls, deviations and CAPAs.

Strong background in training and compliance with demonstrated ability to influence and negotiate to meet business requirements.

Or 4 to 8 years of experience and/or training, or equivalent combination of education and experience.

2 years of college science in Cell Biology, Biochemistry, Chemistry, Biology, with 2 to 4 years of related experience

Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:

Assist CMC team with technical transfer activities.

Assist in the creation of the Bill of Materials for the upstream/downstream process.

Assist in development and creation of the upstream/downstream process.

Bachelor’s Degree in Mechanical Engineering or Manufacturing Engineering, Master’s degree would be a benefit.

Minimum prior work experience of 15 years in the area of mechanical engineering, manufacturing engineering or a closely related engineering field

Significant experience in an industrial, shop or manufacturing environment

Ability to created models and drawings, present design reviews and coordinate multiple project responsibilities

Prior Defense, Nuclear, Power Generation or heavy manufacturing experience with rotating machinery

Experience with manufacturing processes, such as machining, welding, winding, or assembly

Technical Skills: Knowledge of supply chain capabilities, strategies and interdependencies to perform short and long-term business planning Functional Skills and Experience Requirements:

Technical Skills: Knowledge of supply chain capabilities, strategies and interdependencies

Functional Skills and Experience Requirements:

Lead monthly management routines and quarterly Business review and contract management and renewal with Procurement

Budget Management, reporting and audit support

5+ years of experience with supply chain and/or contract manufacturing

10+ years of experience in production management, preferably in Consumer Packaging Goods environment

Master's degree in Business, Industrial Management, Production Management, or related field

Manage on-going activities at external manufacturers and serve as the primary point of contact for production activities

Monitor and analyze supplier processes to ensure adherence to specifications and written requirements, and collaborate to deliver improvements

Experience leading cross-functional teams and fostering teamwork

100% paid employee benefits (medical, dental, vision)

Develop a high level of technical knowledge of project(s)

Motivated, team consciousness individuals are needed to fulfill job requirements.

Experience within cGMP/FDA regulated industry

A minimum of 2 years of experience within the pharmaceutical or biomedical industry

Production of human cell therapy lots through cell culture, harvest, and cryopreservation.

Perform operations utilizing Aseptic technique

Implement visual management on the factory floor for visibility at Gemba to critical metrics.

Demonstrated experience using the following skills:

Strong working knowledge of MS Suite including advanced skills with Microsoft Excel.

Benchmark processes against industry standards, implement certifications as required.

Knowledge in Mechatronics, Optics, Physics a plus

Lean Manufacturing, Continuous Improvement; Six Sigma certification a plus

Strong leadership and project management skills with ability to manage multiple technical projects successfully.

Assist with the preparation of the department budget. Manage budgets and collaborate with Finance to address budget variance.

In-depth knowledge of US and EU regulatory requirements for drug development and cGMPs.

Manage commercial manufacturing of drug substances at CMOs, and lead projects associated with technology transfer and process validation.

Collaborate with Regulatory to set CMC regulatory filing strategies and manage preparation and review of CMC sections of regulatory submissions.

Manage Person-in-Plant coverage to provide adequate oversight for critical drug subtance manufacturing activities.

Skills in planning, organizational, time management and multi-tasking.

Manage personnel, projects, and schedules to perform and complete specific projects according to goals and initiatives.

10 years of Manufacturing and Leadership experience.

Experience working in a regulated environment is required.

Ability to present the site and its capabilities to key customers during site visits and quality audits

Knowledge of protein purification, protein refolding, and protein structure.

7or more years’ experience in Manufacturing and or Manufacturing Engineering with working knowledge of electro-mechanical sub-assemblies.

Summary of Duties and Responsibilities:

- Medical device industry experience.

- Experience with manufacturing line transfers is highly desired.

- Advanced inter-personal skills, communication and emotional awareness is key to be successful in this role.

- Ability to manage projects and lead and coordinate cross-functional teams.

3-5 years of manufacturing experience with educational requirements

Hands on technical knowledge of welding sheet metal and/or Body-in-White process is a plus

Coordinates the introduction of new product and part changes in area of responsibility, balancing work timing, processes and manpower requirements

Minimum Years of Experience Required

Excellent computer skills; proficient in Excel, Power Point and Word

Extensive knowledge of engineering concepts, manufacturing, the product, production standards and efficiency optimization tools

Experience or knowledge in short- and long-term project management is preferred

Minimum of 4 years of related work experience is required

Experience in a manufacturing environment developing manufacturing standards is preferred

Experience in process improvement or maintenance engineering role in the medical devices or pharmaceutical industry preferred

Experience with automated assembly and packaging equipment in the medical device manufacturing environment preferred

Develops imaginative strategies for the efficient completion of projects.

Extensive experience with using project management and/or collaboration tools (e.g., Microsoft Project) required. Strong working knowledge of Microsoft Office is required.

Strong project management and organizational skills, including attention to detail and multi-tasking skills.

Ensure effective selection, training, development, and performance management of the manufacturing team to meet business needs.

Other duties may be assigned as deemed necessary by management.

Ability to extract key facts from complex information and present concise summaries to management.

Knowledge of Lean Manufacturing principles and Six Sigma Black Belt certification strongly preferred.

Coordinate with Supply Planning team and 3rd party management to align on future production needs

7+ years of relevant experience. Bachelor's degree preferred.

Lean manufacturing mindset, with end-to-end supply chain experience, highly self-driven

Highly organized, with strong analytical skills and champions collaboration

Cultivate supplier and manufacturer relationships through regular communication and business reviews

Work to understand available capacity line process detail, and troubleshoot production line layouts for efficiencies and quality

5+ years of hands-on experience in cGMP operational or supporting role

Hands on experience in a cleanroom environment

Detailed knowledge of cGMPs and good documentation practices

Experience leading and/or supporting facility and equipment startup activities

Experience with single use systems and technologies

Knowledge of FDA guidance for gene therapy manufacturing