Job Title:

R&D Project Director

Department:

Research & Development

Reports To:

VP & CSTO/VP

Pay Classification:

Exempt

Position Summary:

The R&D Project Director is responsible for managing key R&D projects. Project management responsibilities include the coordination of key aspects of projects which include project planning with project leaders, monitor progress, timeline, budget, coordinate product validation, regulatory approval and resources. Prepare reports for upper management regarding status of project.

Duties & Responsibilities include but are not limited to:
  • Coordinate project activities with department leads or the cross-functional team leader
  • Coordinate internal resources and third parties/vendors for the flawless execution of projects
  • Ensure that all projects are delivered on-time, within scope and within budget
  • Ensure resource availability and allocation
  • Develop a detailed project plan with project leader to monitor and track progress
  • Manage changes to the project scope, project schedule and project costs using appropriate verification techniques
  • Measure project performance with project leader using appropriate tools and techniques
  • Report and escalate to management as needed
  • Perform risk management to minimize project risks
  • Establish and maintain relationships with third parties/vendors
  • Track project performance, specifically to analyze the successful completion of short and long-term goals
  • Meet budgetary objectives with project leader and make adjustments to project constraints based on financial analysis
  • Develop spreadsheets, diagrams and process maps to document needs
  • Perform other related duties as assigned
Qualifications Required:
  • PhD in Life Sciences or Bio-Medical Engineering with 2-4 years of experience in the medical diagnostic field; experience in immuno-assay field is preferred
  • MS in Life Sciences or Bio-Medical engineering 5-10 years of experience in the medical diagnostic field; experience in immuno-assay field is preferred
  • Experience with FDA and other regulatory agencies is preferred
  • Proven working experience in project management
  • Excellent written and verbal communication skills
  • Solid organizational skills including attention to detail and multitasking skills
  • Strong working knowledge of Microsoft Office
  • Project Management Professional (PMP) / PRINCE II certification is a plus
  • Supervisory experience is preferred

For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.

Job Title:

Director of Manufacturing and Technical Operations

Department:

Operations

Reports To:

Chief Operating Officer

Pay Classification:

Exempt

Position Summary:

Oversees and directs all manufacturing operations, including the quality of all goods produced. Using process, quality and production improvement methodologies, the Sr. Director of Manufacturing and Technical Operations directs the activity of Formulations, Production, and Assembly for new or existing products and technologies through a strong relationship and affiliation with Quality. This individual will also lead, manage, and support the manufacturing groups responsible for product transfer activities from R&D to Operations, process improvements, validations, and investigations, in accordance with applicable regulatory requirements and guidelines. Executes day to day activities to ensure attainment of operational goals, tactics, priorities, as well as identify resource needs. Management responsibilities also include developing and implementing policies and procedures, as well as coaching manufacturing staff, and driving business results.

Duties & Responsibilities include but are not limited to:
  • Direct the efforts and activities of all Manufacturing Staff, which includes Formulations, Production, and Assembly.
  • Engages QA/QC staff to meet daily production requirements according to the manufacturing standards and GMP quality standards.
  • Develops and implements manufacturing capability and capacity, as well as maximizes production schedule to meet and optimize company strategic goals.
  • Facilitates decision-making, resolves conflict, and builds/optimizes cross-functional team efforts to assure that all manufacturing objectives are met.
  • Maintain an active role in facilities planning to optimize work flow.
  • Guide all employees by interpreting policies, goals, and purposes of the organization.
  • Optimize throughput and improve asset efficiency by utilizing engineering resources to increase yields and reduce losses/scrap. Work to improve first pass quality.
  • Fostering a continuous improvement culture through process excellence project management.
  • Continuously look for areas of manufacturing process improvement, which may include additional capital investments, automation, or staffing changes.
  • Works actively on gross margin improvement through annually planned COGS reduction.
  • Maintains ongoing analysis of key issues, projects, and objectives, and provide regular reports that include metrics to summarize the status and trends of key operational parameters.
  • Provide a platform that encourages increases in productivity and improvements in cost management by implementing department goals based on production metrics.
  • Under the direction of the COO, collaborate with Planning and Logistics Department to develop and deploy strategic manufacturing plans that includes manufacturing site capacity, technology, process capability/controls
  • Collaborate with HR in the area of talent development that is aligned with operations objectives, quality objectives, product requirements, and business strategies.
  • Ensure proactive engagement and representation of Manufacturing during product development cycles to ensure future products meet quality, service, and cost objectives.
  • Work in close collaboration and partnership with Finance, Human Resources, Sales, Marketing, Materials, Manufacturing Engineering, Quality, & Regulatory departments to optimize overall operational excellence. Continually apply LEAN manufacturing principles to daily and tactical planning.
  • Provide guidance and leadership on root cause analysis investigations for non-conformances that are the direct result of manufacturing deviations.
  • Utilize talent management to source, attract, select, train, develop, retain, promote, and move employees through the organization in coordination with the company’s overall strategic plan
  • Lead, manage, and support manufacturing groups responsible for product transfer from R&D to Operations, process improvements, validations, and investigations, in accordance with applicable regulatory requirements and guidelines.
  • Collaborate with other departments to manage costs, as well as identify cost savings associated with Production Capacity, Manufacturing Efficiencies, and staffing, while assuring quality requirements.
  • Work effectively with R&D to support new product development activities and assure successful transfer of new products to Manufacturing/QA/QC.
  • Coordinate with other functions (Regulatory Affairs, Sales & Marketing, etc.) to identify customer requirements, and assure these are achieved prior to final release of finished product
Qualifications Required:
  • Bachelors degree or higher in an engineering or science related field. MBA is would be a plus.
  • 6-10 years in progressive operations management experience.
  • Well organized in managing multiple projects and areas of responsibilities through the use of technology tools and managerial experience. Competent in prioritization and work content / resource estimating.
  • Experience with Microsoft Office applications, Visio and ERP systems (Infor Visual or other).
  • Excellent skills in the management of direct, indirect and exempt staff.
  • Competent in inspiring team behavior as well as managing conflict de-escalation and problem resolution.
  • Excellent verbal and written communications skills, as well as strong organizational leadership skills are required.
  • Knowledge of GMP’s, ISO and FDA guidelines related to industry.
  • Knowledge and experience related to automation, equipment qualification and validation in a regulated environment.
  • Familiar with OSHA compliance procedures.
  • Familiar with general accounting principles and practices, project management, and general HR practices.
  • Portrays a positive, can-do, problem solving, professional attitude at all times.
  • Responsibilities include coverage for Managerial duties within a 24/7 work schedule (on and off shore) when issues arise. Occasional weekend and evening work required.
  • Travel up to 20% of the time as required by the company

For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.

Job Title:

Junior Scientist

Department:

Research & Development

Reports To:

R&D Scientist or Director

Pay Classification:

Exempt

Position Summary:

The Junior Scientist is responsible for performing experiments to develop and refine state-of-the-art assays for the detection of infectious diseases

Duties & Responsibilities include but are not limited to:
  • Responsible for the preparation and application of all buffers, test lines, control lines, and other components used in Chembio diagnostic products
  • Analyzes data
  • Writes summaries and reports
  • Performing daily and weekly instrument calibrations as indicated
  • Responsible for maintaining neat and accurate batch records as either an operator or a witness during all procedures
  • Compliance with regulatory standards. Adherence to all OSHA compliance laws and to the requirements of the USDA and FDA
  • Compliance to the requirements of cGMP’s
  • Maintenance of equipment and work area as directed
  • Reporting deviations to established processes
Qualifications Required:
  • Bachelor’s degree in a Life Science or related field
  • Attention to detail and proficient record keeping
  • Computer literate, familiar with Microsoft Office

For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.

Job Title:

Senior Research & Development Scientist

Department:

Research & Development

Reports To:

Director of Research and Development or SVP R&D

Pay Classification:

Exempt

Position Summary:

This position is responsible for planning, organizing and performing experiments to develop and refine state-of-the-art assays for the detection of infectious diseases

Duties & Responsibilities include but are not limited to:
  • Conduct assay system development, optimization and validation.
  • Provide direction and guidance to lab scientist and technicians and other technical personnel implementing, in a timely manner, clinical diagnostic products or services in compliance with industry regulations.
  • Run experiments to evaluate new laboratory instrumentation and equipment for laboratory testing in cooperation with the equipment manufacturer.
  • Prepare technical SOP’s as required for review and approval.
  • Prepare assay validation reports and other assay-related documentation as required by FDA regulations.
  • Assist and/or coordinate technical transfer of new assays and procedures to appropriate departments.
  • In cooperation with the R & D Director, assist in the training of laboratory personnel on new procedures and/or equipment.
  • Assist Scientist or Lab Technicians in solving unresolved technical difficulties in assay implementation and routine operation, when such problems arise.
  • Provide team leadership for designated personnel assigned to specific projects by the SVP of Research and Development.
  • Keep Director and SVP of R&D informed about status of on-going projects
Qualifications Required:
  • Ph.D. in Life Sciences or related field with 0-3 years industry experience or B.S./M.S. in Life Sciences or related with field with a minimum of 5 years experience in a FDA regulated industry.
  • Experience managing an R&D team
  • Proficient with Microsoft Office Suite, requires excellent writing skills
  • Must have knowledge and or involvement in clinical trials

For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.

Job Title:

Lead Facilities Maintenance Mechanic (2nd shift only)

Department:

Operations

Reports To:

Sr. Manager, Facilities & Maintenance

Pay Classification:

Hourly

Position Summary:

The Lead Facilities Maintenance Mechanic is responsible for facility infrastructure, and performing preventative and corrective maintenance/repairs to manufacturing and environmental equipment and the facilities. This position plays a critical role in ensuring uninterrupted service of all manufacturing and facility equipment of rapid diagnostic tests at Chembio, while working in an effective team environment.

Duties & Responsibilities include but are not limited to:

  • Performing general facilities equipment repairs, troubleshooting issues, suggesting improvements, and performing a variety of mechanical and electrical tasks, including: Air Compressors, Pneumatics systems, HVAC, Dehumidification, Plumbing, Security, etc.

  • Performing general facilities repairs, including daily facility and equipment checks.

  • Performing and delegating monthly PM’s of facility equipment.

  • Completing maintenance work requests in a timely manner.
  • Insuring all Good Manufacturing Practices, Lockout/Tagout, Personal Protective Equipment, and Safety procedures are being followed.
  • Procuring of materials required for repair and maintenance of manufacturing and facilities equipment.
  • Designing and implementing improvements in equipment and facility
  • Performing and overseeing projects as determined by the Sr. Manager of Facilities & Maintenance, including; estimating projects, cost of labor and items needed for work orders; acquires competitive prices for supplies and equipment required by the company.

  • Perform Facilities Cleaning duties as needed.
  • Other duties as needed to meet the needs of the department or business schedule.
Requirements:

  • Must have the ability, confidence, and self-motivation to apply talents independently and with good judgment
  • Able to respond to security, facility, and manufacturing issues during business hours, off hours, and weekends.
  • Ability to prioritize and complete work with minimal supervision.
  • Able to use appropriate hand, air, and electric tools to maintain and repair buildings, grounds, and equipment
  • Able to lift up to 50+lbs, climb up and down ladders, stand for long periods of time.
  • Knowledge of facilities-related systems such as HVAC, electrical, pneumatics, vacuum and the ability to adjust and repair such systems.
  • Knowledge of OSHA, building codes and other regulatory requirements a plus.
  • Understand and follow company policies and procedures on Good Manufacturing Practices (GMP’s & SOP’s).
  • Must be flexible to working hours including overtime & weekends

For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.

Job Title:

QA Inspector (1st and second shift)

Department:

Quality Assurance

Reports To:

QA Supervisor

Pay Classification:

Non-Exempt

Position Summary:

Inspect raw materials, packaging components, labels and finished product to ensure conformance to specifications and review batch records for compliance.

Duties & Responsibilities include but are not limited to:
  • Performing inspections for all incoming and outgoing material
  • Communicating inspection failures, deviations, and non-conformances to QA Supervisor.
  • Understanding and following written instructions provided in company procedures and specifications
  • Reviewing batch records and ensuring compliance to the associated procedure, documentation, specifications, etc.
  • Assisting in ensuring compliance to cGMP’s and company policies/procedures.
  • Assisting in communicating and interacting effectively with packaging and production personnel.
  • Performing other related duties as assigned.
Qualifications Required:
  • Knowledge of MS office products (Word, Excel)
  • Detail Oriented
  • Strong organizational and record keeping skills

For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.

Job Title:

Line Leader (2nd shift)

Department:

Assembly

Reports To:

Assembly Supervisor

Pay Classification:

Hourly

Position Summary:

The Line Leader is responsible for executing the Production Schedules insuring compliance to company and federal regulatory guidelines. This position encompasses duties associated with the manufacturing and packaging of components and final product within the Chembio product line.

Duties & Responsibilities include but are not limited to:
  • Performing Line Clearance/Batch Record Review
  • Assigning technicians work assignments in the Assembly departments.
  • Monitoring employee performance and administering company policies;Insuring all written procedures are followed by assembly technicians
  • Insuring all written procedures are followed by subordinates.
  • Maintaining area cleanliness and organization.
  • Completing paperwork associated with the Assembly of Chembio products in a timely manner.
  • Reporting anomalies in the manufacturing process to the Assembly Supervisor.
  • Closing work orders in Visual in a timely manner.
  • Maintaining OSHA compliance.
  • Establish proper training and coaching of all assembly technicians
  • Ensuring all documentation is completed efficiently ,including equipment logs
  • Review all batch records and paperwork for completion and accuracy in a timely manner
  • Maintain adequate inventory of components and supplies
  • Maintains an accurate record of forward traceability for all inventory items
  • Involved in continuous improvement as it relates to department responsibilities
  • Complies with Regulatory standards .Adheres to all OSHA compliance laws and conforms to the requirements of the USDA and FDA
  • Conforms to the requirements of cGMP’s
  • Ensure production output according to the planning schedule
  • Set up lines and stage components
  • Perform all other duties as instructed by the Supervisor
Qualifications Required:
  • Experience in a manufacturing environment.
  • Knowledge related to GMP’s and ISO Standards.
  • Detail oriented.
  • Experienced with Microsoft Office applications.
  • Quality Systems training.
  • Bilingual (English/Spanish) a plus.
  • Attention to detail and proficient record keeping

For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.

Job Title:

Production Team Leader (1st and second shift)

Department:

Manufacturing Indirect

Reports To:

Production Manager

Pay Classification:

Non-Exempt

Position Summary:

Responsible for the direct supervision (training and performance management) of all Production staff, including the execution of day-to-day activities related to the application of reagents and production of cards. Responsibilities include ensuring the manufacturing schedule is met in order to meet production targets in accordance with cGMP/quality requirements and standards. as well as developing, updating, and implementing policies and procedures under the guidance of the Production Manager.

Duties & Responsibilities include but are not limited to:
  • Supervise all operations involved in the production of cards for all Chembio diagnostic products, which includes training, retention and performance development of Production personnel through hands-on training, demonstration, and competency skills assessment
  • Planning and execution of assigned work established by the Planning department. Allocate resources accordingly to assure work is conducted in compliance with manufacturing batch records / quality system requirements, including manufacturing standards.
  • Establishment and improvement of procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards.
  • Ensure consistent execution according to batch records, and that all Production operations are performed according to established SOPs.
  • Work on the manufacturing floor as needed to provide direction, oversight on processes being completed, and aid in the completion of tasks required to meet the needs of the Manufacturing schedule.
  • Communicate with the VP of Operations and Production Planner regarding any nonconformances that arise during processing that will impact scheduled product or delivery dates.
  • Coordination with the Formulations Lab Team Leader to ensure the correct quantity and quality of material is received for application at specified time points.
  • Direct collaboration with the Facilities & Maintenance Manager on all preventative and unscheduled maintenance of equipment performed in the area, in addition to adjustments made to ensure required environmental conditions are met
  • Identify, recommend and implement changes to improve productivity, line efficiency, and reduce cost and down time. Investigating and correcting variances in labor and equipment efficiency standards.
  • Participate in root-cause investigations related to product problems, lot failures and yield discrepancies and recommending corrective and preventative actions.
  • Assists R&D and Regulatory in product transfers, design control, risk management, and RIR investigations.
Skill Sets:
  • Acts with sense of urgency
  • Confident in abilities to elevate issues to the Sr. Leadership Team /Manager while also offering solutions
  • Troubleshooting of issues that arise during processing
  • Able to provide hands-on training with a high degree of understanding and skill
  • Communication with employees & manufacturing support personnel
  • Motivation of employees while providing leadership
  • Ability to assess skill and proficiency level of each employee for required processes
Qualifications Required:
  • Bachelors degree or higher in a science related field preferred.
  • Experience in manufacturing of diagnostic testing devices, experience with current Good Manufacturing Practices (cGMP) and relevant International Standards Organization (ISO) requirements.
  • Experience with Microsoft Office applications and Visual.
  • Excellent verbal and written communications skills, as well as strong technical leadership skills are required.
  • Knowledge of GMP’s, ISO and FDA guidelines related to industry.
  • Familiar with OSHA compliance procedures.
  • Willingness to work on flexible days/hours.

For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.

Job Title:

Laboratory Manager

Department:

Quality Control

Reports To:

Quality Control Director

Pay Classification:

Exempt

Position Summary:

Responsible for managing the Quality Control Unit in the execution of analytical laboratory tests and evaluations of product performance and processes, in accordance with approved methodologies, policies, and associated regulations.

Duties & Responsibilities include but are not limited to:
  • Interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
  • Ensuring that department members are trained to comply with cGMPs, SOPs, GLPs, safety requirements, and all company policies.
  • Implementing and maintaining the analytical testing program applied by the QC Laboratory for evaluation of raw materials, components, and products at various stages of the manufacturing process.
  • Evaluating and justifying purchases of instrumentation/equipment required for performance of tests; initiating and implementing new test methods or conducting method transfer, as appropriate; and executing training of analysts/technicians on new methods of new technology.
  • Validating new methods and modifications to current methods, following regulatory advice for filing strategy before implementation on commercial production.
  • Scheduling laboratory workload to ensure timely completion of tasks.
  • Reviewing and maintaining laboratory data and records in accordance with company policies.
  • Maintaining/coordinating the product stability testing, environmental monitoring, and equipment/ instrument calibration programs.
  • Conducting and coordinating line clearance activities in support of manufacturing processes.
  • Assisting in the performance of quality inspections, audits of quality control programs, and/or internal compliance audits when appointed by the QA Manager/Director; serving in supporting role for many of the Quality Assurance systems (i.e. CAPA, Complaint Handling, Change-Control, Validation).
  • Independently performing and adequately documenting basic investigations for out-of-specification/out-of-trend results.
  • Providing assistance to the Laboratory Director; preparing and presenting staff reports and other necessary correspondence.
  • Providing support in the preparation of annual budget for assigned areas of responsibility.
  • Assisting departmental management in the execution/implementation of projects, as requested.
  • Serving in a leadership role on optimization teams and special project teams, as applicable.
Qualifications Required:
  • High school diploma at minimum, some college level courses or experience in a science related field preferred.
  • A minimum of 5 years of progressive management experience in a Quality Control environment, preferably in the pharmaceutical or medical device industry.
  • Must have a solid working knowledge of GMPs, and familiarity with In Vitro Diagnostic Device manufacturing, USDA, ISO, and OSHA regulations is strongly desired.
  • Must be proficient in MS Word and Excel.
  • Excellent written/oral communication and interpersonal skills are required.

For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.

Job Title:

Assembly Supervisor

Department:

Assembly

Reports To:

Sr. Director of Manufacturing and Tech Ops

Pay Classification:

Exempt

Position Summary:

The Assembly Supervisor is responsible for organizing all assembly activities, including assigning, overseeing, and reviewing the work of all employees in the Assembly Department.

Duties & Responsibilities include but are not limited to:
  • Supervise all assembly activities, including the proper use of equipment used to assemble and pouch components used in Chembio diagnostic products.
  • Monitoring employee performance and administering company policies; insuring all written procedures are followed by assembly technicians.
  • Establish proper training and coaching of all assembly technicians.
  • Assigning line workers and machine operators daily work assignments and responsibilities.
  • Maintaining accurate time accountability for hours worked for each employee.
  • Responsible for coordinating a schedule with the first shift supervisor.
  • Correcting anomalies related to quality and efficiency within the department.
  • Maintaining area cleanliness and organization.
  • Ensuring all documentation is completed efficiently, including equipment and calibration logs.
  • Reviews all batch records and paperwork for completion and accuracy in a timely manner.
  • Responsible for updating all batch records to reflect current practice, and reporting deviations to established processes.
  • Assists in validation protocols for all new equipment and procedures.
  • Maintains adequate inventory of components and supplies.
  • Responsible for closing work orders and labor tickets in Visual in a timely manner.
  • Maintains an accurate record of forward traceability for all inventory items.
  • Assists R&D in RIR investigations.
  • Involved with continuous improvement as it relates to department responsibilities.
  • Complies with regulatory standards. Adheres to all OSHA compliance laws and conforms to the requirements of the USDA and FDA.
  • Conforms to the requirements of cGMP’s.
  • Ensuring production output according to the planning schedule
Qualifications Required:
  • Experience in the field of rapid diagnostic tests or equivalent.
  • Excellent writing skills and experience in generating batch records, SOPs, and deviations.
  • Experience with Microsoft Office applications and Visual.
  • Knowledge and experience with assembly and packaging equipment.
  • Management and Quality Systems coursework or training.
  • Attention to detail and proficient record keeping.
  • Excellent communication and time management skills.
  • Organizational and Leader ship abilities
  • Self-motivated with results-Driven approach
  • Problem solving skills

For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.