Danaher Corporation Director, Technical Operations in Lodi, California
The individual in this role will develop a team of managers and directors that lead and participate in multiple aspects of product support including monitoring manufacturing test data, sustaining and improving process control in manufacturing, maintenance of equipment for the production of quality parts, coordinating and supporting related investigations from all manufacturing sites, and leading investigations raised from field complaints. Investigation activities supported by the failure investigation team include root cause analysis with good experimental design and data justified with statistical analysis. Cepheid’s product lines are integrated systems with respect to engineering design, fluidics, and molecular biology. The individual filling this role will be expected to develop well-rounded expertise in the system as a whole, as well as detailed knowledge of the manufacturing process. The successful candidate will have a broad technical background with demonstrated ability to work collaboratively in a multi-disciplinary environment.
This position requires an individual who has a successful track record of leading technical staff, demonstrated leadership and collaboration skills, and is highly results and goal-oriented. As part of the Global Operations Team, this person will be responsible for delivering safety, quality, delivery, and productivity metrics within Operations.
ESSENTIAL JOB RESPONSIBILITIES:
Manage and mentor highly capable technical team members
Support manufacturing activities by providing first-line investigation activities for production
Ensure that the manufacturing processes are in control and the equipment used in production produces high-quality parts that meet specifications
Leads process validation and verification efforts for assays, manufacturing lines, and production equipment
Supports the creation of work instructions and ensures manufacturing alignment with validated processes
Liaisons with product design and development teams (Engineering and Biotechnology) to ensure processes and designs are robust and compatible with manufacturing processes
Demonstrate process knowledge to find opportunities/solutions to improve throughput and utilization by reducing the impact of constraints
Provides support for investigations related to production at other manufacturing sites
Further develop and manage ongoing SPT activities to monitor key manufacturing data as well as field performance of Cepheid products
Effectively collaborate closely with other areas of the organization including R&D, QS, Manufacturing Engineering, TS, Engineering, CSET, SI, and Biotechnology to ensure successful failure investigations, root cause identification, and effective problem mitigation
Provide technical leadership and know-how with product performance issues
Acts as an advisor to direct reports to meet schedule and/or resolve technical problems. Coaches team on job performance and development.
Leads and coordinates the activities of the project(s) with responsibility for results in terms of timelines, cost objectives, and process implementation.
Handles validation and testing activities of matrix teams that may include both in-house technical personnel and outside consultants and contractors.
Supports process development, improvement, and troubleshooting activities within the Manufacturing organization.
Responsible for budgets within his/her department and resource planning to meet project objectives.
Builds, inspires, appropriately aligns, and integrates multiple teams to achieve business goals
Education or Experience :
Bachelor’s or Master’s degree in Life Sciences, Bioengineering or Engineering with 10+ years of relevant experience
Minimum of 8 years technical managerial experience being responsible for diverse projects and individual contributors with a technical/scientific degree
Knowledge and skills:
Demonstrated success in managing sophisticated programs within an operations environment
Requires a thorough understanding of validation principles, quality system requirements, and ISO/FDA compliance requirements
Demonstrated proficiency and knowledge of manufacturing workflows, systems, and requirements, including cGMP/GLP practices
Solid understanding of the design of experiments, interpretation of test results, failure investigation, and root cause failure analysis
Demonstrated analytical problem-solving skills to understand reagents, hardware, software, and consumables issues and to be able to quickly analyze and resolve system inter-operability problems
Strong technical knowledge of chemistry and/or biological sciences, with experience in the integration onto equipment and systems platforms.
Strong people management experience in a technical field is required.
Excellent communication skills, both verbal and written are needed.
Demonstrated abilities leading teams and promoting successful collaboration across multi-disciplinary teams
Demonstrate high flexibility to adapt to changing business environments and effective at handling multiple projects simultaneously and in a timely manner
Demonstrated leadership skills and ability to adapt to changing business environments.
The ability to successfully connect with multiple departments is critical
Deep understanding of manufacturing operations, process engineering, and equipment engineering
Well versed with lean manufacturing principles
- Prior experience in diagnostic/medical device and/or biopharmaceutical equipment and systems
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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .
Operating Company: Cepheid