The following positions are available at our offices in Brooklyn, NY:

Quality Control Technician I

Position Summary

The Quality Control Technician I will assist in the development of Quality Control (QC) procedures, specifications, testing, and verification of clinical grade tissue engineered products.

Position Activities

Works in a highly regulated environment and performs assays which are used as environmental, in-process, and release criteria results for a cGMP tissue engineered product. Evaluates materials and reagents for use in manufacturing of clinical grade tissue engineered products, and obtains proper documentation pertaining to those materials. Develops and performs biochemical assays of human tissue samples including quantitative analysis (ALP, calcium, DNA and glucose), flow cytometry, ELISA, and qPCR for use in cGMP manufacturing of a tissue engineered product.

Minimum Requirements

BS degree in biology, biomedical engineering, and/or related fields with 1-3 year(s) of relevant laboratory experience. GPA 3.0 or higher is required. Independent research experience outside of laboratory course work is strongly desired.

Job Responsibility

  • Perform and analyze QC assays of manufactured products including flow cytometry, gram stain, endotoxin, ELISA, qPCR, and quantitative analysis (ALP, calcium, DNA and glucose).
  • Ensure company compliance with regulatory requirements.
  • Maintain and optimize SOPs as needed.
  • Handle biological materials from human subjects.
  • Prepare and maintain detailed records and summary reports of all procedures and results including graphs and scientific calculations.
  • Prepare Certificate of Analysis for manufactured products.
  • Organize and present data at laboratory meetings.
  • Manage clean room supply chain.
  • Produce consistent and accurate results.
  • Check work for accuracy before completion of tasks.
  • Maintain accurate record of all tests performed, documenting test results.
  • Perform other job-related duties as required.

Highly Desired Requirements

Previous experience with laboratory methods defined under “Job Responsibility” is highly desired. Prior experience in a QC role at a cGMP compliant biotechnology company is preferred.

Qualifications

  • Maintain accurate record of all tests performed, documenting test results.
  • Demonstrate excellent communication and writing skills.
  • Strong organizational skills with high attention to detail.
  • Demonstrate critical thinking, self-initiative, and team work ability.
  • Must be able to work independently and with a team.
  • Proficient in Microsoft Excel, Microsoft PowerPoint, and Microsoft Word.

Working Conditions/Physical Demands

Ability to lift 25lbs or more on a regular basis.

No relocation assistance is provided for this position.

Visa sponsorship is not available for this position.

Schedule

Full-time

Overtime Status

Non-exempt

EpiBone, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, gender, gender identity or expression, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, EpiBone ,Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

**Qualified applicants, please submit your cover letter and CV for consideration to: mike@epibone.com.

Research Scientist, Cartilage

Position Summary

The Research Scientist, Cartilage position will assist in the research and development of tissue engineered cartilage products, document research results via technical reports, and present technical findings to R&D community and management.

Position Activities

Works in a highly regulated, collaborative team environment to perform benchside R&D to cGMP-level tissue engineered product development. Create, maintain and optimize SOP, create and execute research protocols, and maintain proper documentation of pertinent research results. Evolve and grow with the team as workload evolves from R&D to clinical trials.

Minimum Requirements

PhD or equivalent experience in biomedical engineering, material science, and/or related fields with 0-2 year(s) of relevant experience.

Job Responsibility

  • Perform research for the development of tissue engineered cartilage products.
  • Independently design and execute experiments for scientific investigation and process optimization.
  • Maintain, create, and optimize SOPs as needed.
  • Handle biological materials from human subjects.
  • Prepare and maintain detailed records and summary reports of all procedures and results including graphs and scientific calculations according to good R&D documentation practices.
  • Organize and present high-quality analytical data at group, department, and cross-functional team meetings.
  • Prepare comprehensive progress reports for grant related projects.
  • Perform other job-related duties as required.

Highly Desired Requirements

Previous experience in fabricating and testing hydrogels and/or control release microparticles is high desired. Prior experience working within a GMP compliant facility is a plus.

Qualifications

  • Produce consistent and accurate results.
  • Check work for accuracy before completion of tasks.
  • Demonstrate excellent communication and writing skills.
  • Strong organizational skills with high attention to detail.
  • Demonstrate critical thinking, self-initiative, and team work ability.
  • Maintain accurate record of all tests performed, documenting test results.
  • Able to support management and work in cross-functional teams that evolve quickly.
  • Must be able to work independently and with a team.
  • Proficient in Microsoft Excel, Microsoft PowerPoint, and Microsoft Word.

Working Conditions/Physical Demands

Ability to lift 25lbs or more on a regular basis.

No relocation assistance is provided for this position.

Visa sponsorship is not available for this position.

Schedule

Full-time

Overtime Status

Non-exempt

EpiBone, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, gender, gender identity or expression, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, EpiBone ,Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

**Qualified applicants, please submit your cover letter and CV for consideration to: blake@epibone.com.