Director, Manufacturing

Company: Danaher
Location: Lodi
Posted on: June 12, 2021

Job Description:

The Director of Manufacturing is responsible for the organization, planning, compliance, and execution of GMP manufacturing operations for reagents, consumables, and finished goods (fill-pack) for 24X7 manufacturing operation in Lodi, CA. This will include leading and strengthening a team and identifying and implementing policies, procedures, and manufacturing strategies to facilitate optimal production and performance. This position is hands-on and requires strong production and supply chain leadership skills. The ideal candidate will be responsible for ensuring a culture of high performance, collaboration with multicultural cross-functional teams, continuous improvement, operational excellence initiatives, standard processes, and use of metrics for accountability and sustainability.

ESSENTIAL JOB RESPONSIBILITIES:

• Provide oversight and management of consumables and finished goods (filling and packaging) manufacturing operations to meet Cepheid's Business drivers and objectives.
• Develop and introduce best-in-class operations excellence initiatives to improve quality, productivity, and performance.
• Provide technical expertise in process design, optimization, and scale-up for sophisticated manufacturing candidates.
• Participate as a key member of the operations management team by proactively engaging cross-functionally to achieve manufacturing goals. Ensure that reporting staff understands the shared responsibilities for goals and responsibilities.
• Participate as the Manufacturing Operations Lead in department strategic planning sessions
• Lead, develop, and mentor department management staff, with an emphasis on functional and cross-functional partnership, planning, follow-up, and effective communication.
• Demonstrate high flexibility to adapt to changing business environments and effective at handling multiple projects simultaneously and in a timely manner.
• Accountable for project results, adherence to the cost center budget, and development and management of Capital expenditures for Manufacturing.
• Define, establish, monitor, and report key performance metrics to meet manufacturing objectives.
• Drive continuous improvement within manufacturing through the use of sound scientific values, lean manufacturing principles, and Danaher Business System tools.
• Lead the manufacturing operation in problem-solving with regards to equipment, systems, and product flow.
• Lead product lifecycle from initial tech transfer through closure including but not limited to process flowcharts, risk assessments, safety reviews, generation of batch documentation, change controls, process controls, and process qualification and validation.
• Resource planning, staff development, and talent performance management.
• Champion for continuous improvement and operational efficiency to eliminate waste and reduce COGs within manufacturing operations.
• Plan, schedule, and communicate production schedules across multiple operational functions.
• Actively promote a culture of safety and quality.
• Assigns duties and coordinates activities of supervisors and/or employees; maintains schedules and manpower requirements for assigned areas.
• Identify production optimization opportunities via analysis of current processes / procedures and make recommendations for improvement.
• Recognize and solve problems affecting production including schedules, staff, quality, and order of production line.
• Prioritize production activities based on volumes, equipment efficiency, and material supply.
• Interact closely with other departments outside of operations (Engineering, Product Development, Clinical, etc.) in support of new product and process development.
• Plans and administrates procedures and budgets. Make budgetary recommendations regarding capital expenditure and direct / indirect labor
• Measures progress by established standards of performance. Performance measurements may include parts per day (PPD), overall equipment effectiveness (OEE), work in progress inventory tracking, targeted yields, rejects/scrap, non-conforming records, floor-stock cycle count accuracy, and others defined through quality and productivity initiatives.
• Maintain a work environment in adherence to FDA cGMP and ISO13485 requirements.

MINIMUM REQUIREMENTS:

Education and Experience:

• Bachelor's degree in industrial engineering or life sciences and a minimum of 10+ years experience manufacturing medical devices with increasing responsibility including supervision of direct labor

Knowledge and skills:

• Lean Six Sigma experience required, greenbelt or blackbelt strongly preferred
• Able to apply critical thinking
• Excellent attention to detail, flexible and adaptable to change
• Able to operate under pressure, multitask, set priorities, and meet target dates
• Proficient with Word, Excel, Visio, and MRP systems a plus
• Must exhibit strong leadership skills, both with subordinates and peers, with emphasis on relationship development and implementation of company culture improvement initiatives.
• Must have excellent written and oral communication abilities.

• Able to present sophisticated theoretical concepts and empirical scientific data effectively and concisely

• Able to articulate clearly and engage in dialogue with all levels within the organization

• Able to influence with others in a fast-paced, cross-functional, matrixed organization.

• Prior work experience in a GMP operations function (IVD manufacturing)
• Strong analytical and technical skills
• Motivated self-starter, capable of achieving objectives in a demanding environment.
• Extremely detailed, accurate, and highly organized.
• Excellent problem-solving skills and judgment.
• Requires excellent interpersonal and communication skills. Ability to work well with people. Ability to interface successfully with various departments and be a part of their teams.

PREFERRED REQUIREMENTS:

• Prior experience in diagnostic/medical device and/or biopharmaceutical equipment and systems

Preferred Qualifications: MBA

The statements in this description represent typical elements, criteria, and general work performed. They are not intended to be a comprehensive list of all responsibilities, duties, and skills for this job.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here.

Keywords: Danaher, Lodi , Director, Manufacturing, Other , Lodi, California