Quality Control Technician

Company Overview & Position Description

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

Essential Functions & Responsibilities

• Develops and performs QC assays for manufactured products, including flow cytometry, gram stain, endotoxin, ELISA, qPCR, colorimetric assays, and fluorometric assays.
• Analyzes and interprets assay results.
• Undertakes activities to ensure corporate compliance with regulatory requirements as it relates to cGMP standards.
• Creates, maintains, and optimize SOPs as needed.
• Maintenance of cGMP Machinery.
• Prepare and maintain detailed records and summary reports of all procedures and test results.
• Prepare Certificates of Analysis for manufactured products.
• Organize and present data at meetings when requested.
• Assist in the management of clean room supply chain.
• Perform other job-related duties as required.

Minimum Qualifications

• Bachelor’s degree in the life sciences (biology, biomedical engineering, or related field) is required.
• Minimum of 2-3 years of relevant laboratory experience.
• Excellent communication, presentation, and record-keeping skills.
• Able to work in a fast-paced and cross-functional environment.
• Extremely organized and self-managed.
• Comfortable with working traditional and non-traditional hours.
• Proficient in standard Office programs like Word, PowerPoint, and Excel.

Preferred Qualifications

• Prior experience in a QC role at a cGMP compliant biotech/pharma company is highly desired.
• Previous experience work with tissue engineered products.

Working Conditions/Physical Demands

• Visa sponsorship is not available for this position.
• No relocation assistance is provided for this position.
• Ability to lift 25lbs or more on a regular basis.

Employment Status

• Full-time; exempt from overtime.

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.

Laboratory Manager

Company Overview & Position Description

EpiBone is a clinical-stage company that develops revolutionary tissue engineered products for skeletal repair, and is offering the chance to work with an early-stage company to support the clinical translation of innovative regenerative stem cell therapies. We are seeking an experienced Laboratory Manager to provide research and administrative support in both our basic science and cGMP laboratories.

Essential Functions & Responsibilities

• Orders and maintains inventory of supplies, equipment, reagents, etc. This includes receiving orders and confirming the accuracy of the deliveries to monitor supply chain and cost control.
• Develops, implements and enforces policies and procedures to support laboratory safety, efficiency and quality control.
• Provides orientation, training and supervision of staff, and new lab members in the application and use of new equipment, as well as, maintaining and following the standard operating procedures for laboratory activities.
• Manages all necessary equipment maintenance, repairs, certifications, and calibrations.
• Ensures laboratory is in compliance with all local, state and federal regulatory requirements.
• Develops and submits reports as necessary to overseeing agencies.
• Handles routine cleaning and maintenance. (e.g. cleaning dishes and incubators, laundry pick-up, and LN2 refilling)
• Serves as the point of contact for all related laboratory issues.
• Conduct basic aseptic laboratory activities as needed, such as reagent and media preparation.
• Perform other job-related duties as required.

Minimum Qualifications

• Bachelor’s degree in a scientific field is required; with educational emphasis in the life sciences,
• Minimum of 3-5 years of experience in laboratory management.
• Excellent communication, presentation, and record-keeping skills.
• Able to work in a fast-paced and cross-functional environment.
• Extremely organized and self-managed.
• Comfortable with working traditional and non-traditional hours.
• Proficient in standard Office programs like Word, PowerPoint, and Excel.

Preferred Qualifications

• Knowledge of aseptic techniques.
• Experience handling and maintaining hazardous waste and materials.

Working Conditions/Physical Demands

Visa sponsorship is not available for this position. No relocation assistance is provided for this position. Ability to lift 25lbs or more on a regular basis.

Employment Status

Full-time; exempt from overtime.

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.