BioCode for Better Health

 

Career Opportunities at Applied BioCode Inc.

Working at Applied BioCode Inc.

Here at Applied BioCode Inc., we value the diversity of culture and thought. We're looking for talented individuals to join us as we continue to remain a leader in this community and in our industry. We are dedicated to continuing what we believe to be an excellent employee relations program, where we strive to maintain good working conditions, competitive wages and benefits, open communications, and employee involvement. Nestled in the heart of beautiful Santa Fe Springs, California, we invite you to browse our current openings and consider a career with Applied BioCode Inc.

Open positions are listed below.

 

 

Scientist/ Sr. Scientist

Job Description/ Position Objective:

Development and validation of PCR-based multiplex assays for FDA submission and clearance.

Essential Functions

  • Molecular Biology: real-time PCR, designing primers & probes, probe-based hybridization and detection, nucleic acids extraction and Sanger sequencing
  • Microbiology: bacteria/virus cultures, handling BSL-II agents and processing clinical specimens
  • Analyze assay results and perform follow up experiments. Must maintain a laboratory note book according to GDP and be able write up and present data to peers and management
  • Perform other related duties as required and/or assigned
  • Education:

  • Degree in biochemistry, microbiology, molecular biology, or related fields. PhD with 2+ years of experience, MS with 5+ years of experience, BS with 7+ years of experience

  • Experience/Requirements:

  • Strong background in molecular biology, biochemistry, and/or microbiology techniques
  • Must have hands on experience in PCR-based assays and primer design
  • Strong background in experimental design and ability to execute complex experiments
  • Excellent problem solving ability with attention to details
  • Experience with IVD assay development and Design Control process is a plus
  • Excellent time management skills, and ability to prioritize and execute various tasks
  • Demonstrates a sense of urgency, strong work ethics and a "can do" attitude
  • Is curious, inquisitive, innovative, and strives to improve the status quo
  • Willingness to take on challenges and changes as opportunities
  • Collaborates with others in a team-oriented environment
  • Follows Quality System requirements, safety rules and applicable regulations
  • Embraces and leverages diversity of culture and thought

Working Conditions:
Works in a laboratory environment. Is required to lift up to 20 lbs. May be required to sit or stand for long periods of time while performing duties. Ability to work safely with hazardous chemicals and infectious agents. Willingness to work overtime and flexible schedule as needed is a plus.

Scientist/ Sr. Scientist candidates please email resumes to: bioSS@apbiocode.com



Research Associate

Job Description/ Position Objective:
Development and validation of PCR-based multiplex assays for FDA submission and clearance.

Essential Functions:

  • Molecular Biology: real-time PCR, multiplex endpoint PCR, probe-based hybridization and detection
  • Microbiology: bacteria cultures, handling BSL-II agents and clinical specimens for nucleic acid extraction
  • Design, perform and evaluate experiments as instructed
  • Determine and apply basic statistical techniques for data analysis
  • Must maintain a laboratory note book according to GDP and be able to analyze assay results
  • Prepare and order reagents and lab supplies
  • May be required to perform other related duties as required and/or assigned

  • Education:

  • BS Degree in biochemistry, microbiology, molecular biology, or related fields with 1-2 years of experience

  • Experience/Requirements:

  • Strong background in molecular biology, biochemistry, and/or microbiology techniques
  • Must have hands on experience in setting up PCR-based assay
  • Ability to execute complex experiments with attention to details
  • Experience with IVD assay development and Design Control process is a plus
  • Ability to prioritize and execute various tasks
  • Demonstrates a sense of urgency, strong work ethics and a "can do" attitude
  • Is curious, inquisitive, innovative, and strives to improve the status quo
  • Willingness to take on challenges and changes as opportunities
  • Collaborates with others in a team-oriented environment
  • Follows Quality System requirements, safety rules and applicable regulations
  • Embraces and leverages diversity of culture and thought

Working Conditions:
Works in a laboratory environment. Is required to lift up to 20 lbs. May be required to sit or stand for long periods of time while performing duties. Ability to work safely with hazardous chemicals and infectious agents. Willingness to work overtime and flexible schedule as needed is a plus.

Research Associate candidates please email resumes to: bioRA@apbiocode.com



Manager/Senior Specialist, Quality Assurance

Job Description/ Position Objective:
The role of the Manager or Senior Specialist of Quality Assurance is to establish and execute sound strategies for the Quality Management System (QMS) associated with new product development through commercialization, including post-market surveillance.

The Individual serves as a core team member, leads the QMS and communicates the impact of regulations to product development, manufacturing, clinical operations, and/or the commercial organization for their projects. The Individual will lead all activities associated with process validation, CAPA, documentation, and Audits, both internal and external. He/she will develop in-depth understanding of technical/scientific principles that relate to their specific product(s) and manufacturing process. The Individual will possess excellent communication skills, both oral and written, demonstrated through formal written reports/documents or presentations.

The Individual will be expected to recognize potential problems, and alert management prior to or after their occurrence with potential solutions. He/she will suggest functional opportunities for improvement that have a noteworthy impact (cost, cycle time, quality, etc.) for the function and be responsible for developing or implementing the plan. The Individual exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results and will be recognized as leader within the Company. He/she may be assigned a mentor role for others, including helping them with projects, career goals, and other developmental tasks.

Essential Functions:

  • Creates and executes quality strategies and plans for the QMS, ranging from simple to high complexity
  • Provides a high level of expertise and experience to the Team, while serving as a project member or Team member. Holds signature responsibility for designated areas
  • Represents the Company in interactions and negotiations with regulatory agencies regarding quality requirements and strategies. Organizes and manages meetings with regulators, including agendas and training/preparation of Company personnel attending the meetings
  • Monitors FDA, EU and ISO laws and regulations, and provides their interpretation to company leadership. Provides comments to management for inclusion in responses to FDA and other agency legislation/regulation/guidance
  • Serves as a team expert for material review board, product labeling as they relate to registration and commercialization of medical devices
  • Suggests opportunities for improvement that have a significant impact (cost, cycle time, quality, etc.) and assists in developing or executing an implementation plan
  • May be required to perform other related duties as required and/or assigned

  • Education/Qualifications:

  • B.A. or B.S. degree in science or life science field (electrical/mechenical engineering, medical technology, biology, microbiology, chemistry, etc.), or B.A. or B.S. degree other related discipline with significant coursework in areas listed above.
  • 7-10 years directly applicable quality assurance work experience with instrument software, hardware, and assays development with increasing responsibility in an IVD or medical device company.
  • Knowledge of start-up companies' unique requirements & limitations

  • Experience/Requirements:

  • Interprets subjective and complex aspects of specific regulations and has general understanding of multiple sets of associated regulations
  • Holds understanding of technical/scientific principles that relate to regulated products, specific product lines, or manufacturing processes
  • Demonstrates excellence in both oral and written communication within the department, between functional groups, and externally
  • Prepares formal written reports/documents for distribution within and external to the department. Orientation for detailed work product, with emphasis on timeliness, accuracy and completeness
  • Knows appropriate contact points and interactions with their manager as required by specific issues, milestones, or status changes
  • Exercises independent judgment and discretion within a defined range of policies and practices. This includes recognizing problems and using analytical problem skills to resolve them
  • Demonstrates being action oriented, having focused urgency and driving for results
  • Shows proficiency in team skills with ability to influence others
  • Handle multiple tasks well and to prioritize and schedule work to meet business needs
  • Fosters collaboration among team members
  • Demonstrates computer literacy (PC, Microsoft Word/Excel/Powerpoint)
  • Embraces and leverages diversity of culture and thought

Working Conditions:
Works in an office environment. Required lifting analyzers as needed. May be required to sit or stand for long periods of time while performing duties.

Manager/Senior Specialist, Quality Assurance candidates please email resumes to: career@apbiocode.com



Company Benefits

Applied BioCode, Inc.'s employees enjoy the following benefits:

  • Incentive Stock Options or Restricted Purchase Agreement
  • 401(k) retirement plan with company contribution
  • Health insurance
  • Dental insurance
  • Flexible work hours
  • Flexible Spending Accounts
  • Health Saving Accounts

Detailed benefits will be provided upon the commencement of employment. Please note that benefits are subject to change.