Quality Control Supervisor/Manager

EpiBone is a clinical-stage company that develops revolutionary tissue engineered products for skeletal repair, and is offering the chance to work with the company to support the clinical translation of innovative regenerative stem cell therapies. We are seeking a Quality Control Supervisor/Manager to develop the Quality Control (QC) analytical procedures, specifications, testing, and verification of clinical grade tissue engineered products.

Manages the activities of QC function, ensures data integrity of QC data in support of regulatory submissions.
Develops and troubleshoots QC analytical assays for scientific research and manufactured products, including flow cytometry, gram stain, endotoxin, ELISA, qPCR, colorimetric assays, and fluorometric assays.
Reviews and/or performs QC system activities such as in process, release and stability testing, information management, investigations, method validation, method transfer, instrument qualification, corrective actions/preventive actions management.
Authors and approves SOPs, protocols, reports, data summaries, and Certificates of Analysis for manufactured products.
Works in collaboration with internal Quality Assurance to establish, maintain, and improve QC cGMP compliance and documentation.
Oversees the effective utilization of the Quality Management System by QC laboratory personnel, develops and maintains compliance metrics and reports for management.
Accountable for thorough, well documented and timely laboratory deviation/investigation reporting.

Bachelor’s degree in the life sciences (biology, biochemistry, biomedical engineering, or related field) is required.
Minimum 5-7 years of QC experience at a cGMP compliant cell and gene therapy company, and/or other related biologics company.
1-3 years of supervisory experience.
Experience with development and implementation of methods used in testing of biological products.
Self-managed with impeccable organizational and record-keeping skills, and a keen eye for reviewing data.
Excellent oral/written communication and interpersonal skills with ability to multitask while working under restrictive timelines.
Comfortable with working traditional and non-traditional hours.
Proficient in standard Office programs like Word, PowerPoint, Excel, and standard statistical programs.
Previous experience working with Quality Management Systems and filing quality events.

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, sexual orientation, 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.

Biomedical Automation Engineer

EpiBone is a clinical-stage company that develops revolutionary biomedical tissue engineered products for skeletal and cartilage repair and is offering an engineering opportunity to work with an early-stage company developing cutting-edge technology to support the clinical translation of innovative regenerative stem cell therapies. We are at an exciting transition point, scaling up clinical and pre-clinical production, and are seeking an automation engineer to help shape the next phase of bioreactor control and automation.

The automation engineer will play a critical role in driving the design, assembly, and testing of bioreactor systems for clinical- grade tissue engineered medical products. The engineer should have strong programming and circuit design skills who can integrate signals from many electromechanical devices to improve device reliability and meet user needs. The candidate will have the opportunity to work on a variety of projects in a fast-paced and collaborative environment. Under the engineering manager’s supervision, the automation engineer will join a passionate and diverse team of biomedical researchers on a mission to commercialize cutting edge medical products that truly restore body function.

Design, assemble, test, and revise electromechanical systems.
Program and troubleshoot microprocessor and PLC software.
Review part specifications to identify components (sensors, motors, controllers) for design criteria.
Develop electrical drawings and assemble control systems.
Perform other duties as assigned.

Bachelor’s degree in Mechanical, Electrical, or Biomedical Engineering with at least 3 years of work experience or Master’s/PhD degree with 1-3 years of work experience.
Highly proficient in electrical design, data acquisition, and control systems.
Minimum of 1 year of experience coding with using Python, Rockwell, C.
Fundamental understanding of engineering design process, risk management, and good documentation practices.
Ability to interpret and generate schematics, diagrams, and technical reports.

Has experience designing and setting up automation systems, SCADA, sensor integration, and HMI.
Familiar with requirements for biotech automation, 21 CFR software compliance, and electrical safety standards.
Proficient using Solidworks, Mastercam, and operating CNC machinery.

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, sexual orientation, 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.