Posted on: June 12, 2021
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
- 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
- Resource planning, staff development, and talent performance
- Champion for continuous improvement and operational efficiency
to eliminate waste and reduce COGs within manufacturing
- 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
- Identify production optimization opportunities via analysis of
current processes / procedures and make recommendations for
- 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
- 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
- Maintain a work environment in adherence to FDA cGMP and
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
Knowledge and skills:
- Lean Six Sigma experience required, greenbelt or blackbelt
- Able to apply critical thinking
- Excellent attention to detail, flexible and adaptable to
- 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
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,
- Prior work experience in a GMP operations function (IVD
- Strong analytical and technical skills
- Motivated self-starter, capable of achieving objectives in a
- 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.
- 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
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
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