BD (Becton, Dickinson and Company) Lab Manager, Custom Products in San Diego, California
Job Description Summary
The Lab Manager, Custom Products is responsible for:
Management of all laboratory related activities for the Customs Technology Team (CTT), including new product development and manufacturing of custom product offerings. Implementation of new assays and technologies, in collaboration with R&D, to grow custom product portfolio. Identification of new equipment and need for automation
Assay design and development with empahsis on flow cytometry assays for the assessment of cellular response to changes in the normal physiological make-up, immunophenotyping and L&L diagnosis. These assays could be used in clinical reference labs and in the evaluation of candidate therapeutics in development at Pharmaceutical and Biotechnology companies. Requires close interaction with external customers, team associates and other functional groups.
Oversee laboratory work efforts and evaluate resource requirements to support incoming work and ensure all project timelines are met. Manage capacity plans. Ensure inventory and stock levels fro the upcoming lab activities. Develop processes for efficient work flow and reducing turnaround time. Coordinate with CTT Operations to identify bottlenecks in the laboratory during product development and/or production to ensure streamlined and efficient daily operations. Focus on process standardization and continuous improvement opportunities to optimize workflows and increase efficiencies by monitoring problem trends, investigating root cause and identifying/implementing solutions.
Job Duties and Responsibilities:
Responsible for interfacing with customers, including active participation in discussions relating to the development of assays and products aimed at customer-specific applications.
Supervise laboratory personnel to ensure customer requirements are applied to the product manufacturing specifications or assay development.
Design and review experimental methods/techniques required for new projects. Review, analyze and organize data for final reporting while adhering to quality documentation and procedures.
Accountable for ensuring customer satisfaction by delivering high quality end-products, while adhering to aggressive timelines and working with multiple functional sites and groups including Operations, Manufacturing, Quality, Instrumentation, etc.
Provide post-sales support by responding to customer inquiries/complaints, troubleshooting in user-lab conditions, developing alternate strategies to an emerging problem, and coordinating internal quality discussions. Interact with senior external personnel on significant technical matters, coordinating disucssions between organizations.
Assess quality issues, deviations and CAPAs related to manufacturing operations, including the investigation and documentation of process variances.
Continually look for opportunities to refine existing methodologies and procedures to optimize workflows and increase efficiencies, including new technologies related to innovation and automation.
Responsible for developing and writing controlled documents, SOPs, and maintaining high quality standards to meet ISO and GMP manufacturing standards, including assay and instrument related validation protocols and procedures.
Ability to troubleshoot and perform engineering studies relating to standard/new lab equipment. Familiarity with lyophilization techniques and lyophilizers strongly preferred.
Develop technical and business process solutions to complex problems, which require the use of ingenuity and creativity.
Experience in clinical trial data management, including the analysis and uploading of data into various web portals.
Maintain on-going communications and relationships with R&D, Operations, Sales, Marketing, and Instrumentation with the goal of increasing productivity.
Monitor and evaluate new, emerging technologies within and outside the company to improve products and processes.
Assist management in creating expense budgets.
Follow and participate in BD Biosciences Environmental, Health and Safety (EH&S) policies and procedures.
Take responsibility for safety in immediate work area and notify supervisors of all observed hazardous conditions or unsafe work practices. Provide recommendations on maintaining safety in the work environment.
Performs other related duties and assignments as required.
Position will report to the Associate Director/Director of the Customs Team.
Knowledge and Skills:
Must possess accomplished communication skills and strong interpersonal skills.
8+ years’ relevant experience in product development and design with at least 5 years product development and design experience in medical devices/reagent industry.
Work experience in a clinical flow cytometry laboratory with expertise in running flow cytometers including validation protocols is strongly recommended
Thorough technical and operational knowledge of current generation of flow cytometers and associated software applications.
Demonstrated ability to plan the development and production of multi component products including ability to work with various functional groups
Proficiency in cell culture techniques, cellular assays, and immunoassays is required.
Proven ability to develop quality assays and products for clinical reference lab leading to high customer satisfaction is required.
Experience in data management, including analysis and uploading of data in various web portals.
Familiarity with various quality systems such as GLP, GCP, GMP, ISO.
Documentation skills with attention to detail in writing professional reports, SOPs and Validation documents is required.
Experience in customer interactions and carrying out on-site technical demonstrations with emphasis on troubleshooting is highly desirable. Ability to properly document such events is required
Proficiency in Word, Excel, Power point, Visio and business management software is expected.
Experience with SAP or other operational databases is desirable.
Requires a highly motivated and energetic person with ability to shoulder responsibility and be able to maintain an enthusiastic team environment.
A demonstrated ability maintaining current knowledge of recent scientific and technical developments in the field is expected.
Education and Experience:
8 years’ relevant experience in product development and design with at least 5 years product development and design experience in medical devices/products
Typically requires a B.S. with a minimum 10+ years / M.S. with 7+ years / Ph.D. with 4+ years of related laboratory and technical experience in an industrial or production environment.
Prior experience in a clinical flow cytometry laboratory is preferred.
Primary Work LocationUSA CA - San Diego (BDB)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status