Cellular Tissue Manufacturing Associate

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 join an early-stage company to support the clinical translation of innovative regenerative stem cell therapies. The candidate will be working with a passionate and diverse team at EpiBone on a mission to commercialize cutting edge medical products that truly restore body function
We are seeking a Tissue Manufacturing Specialist to join our fast-paced GMP manufacturing team to produce clinical grade stem cell-based tissue products. The candidate will also have the opportunity to engage in the development, testing, and implementing cutting edge technology to scale the production of tissue engineered medical products as the company transitions toward large-scale clinical trial.

Essential Functions & Responsibilities

Culture primary human cells, perform 3D tissue culture, and prepare reagents per standard operating procedures (SOP) while utilizing aseptic techniques
Support tech transfer of products and processes to ensure smooth transition from development into GMP manufacturing
Design, execute, and document experimental process development protocols/reports
Maintain batch records, review GMP data, and clearly document manufacturing activities
Maintain calibration and preventative maintenance of GMP manufacturing equipment
Monitor, place order, and re-stock supply inventory as necessary
Perform all associated manufacturing and related tasks
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

BS degree in biology, biomedical engineering, or related science field
Detail oriented with strong analytical, problem solving, and critical thinking skills
Experience with general lab safety and aseptic technique
Ability to work flexible and/or non-traditional hours, including occasional weekends
0-2 years of adherent cell culture experience
0-2 years of experience in biopharmaceutical based GMP manufacturing operations
Familiarity with Microsoft applications

Preferred Qualifications

2-4 years of adherent cell culture experience
2-4 years of experience in biopharmaceutical based GMP manufacturing operations

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.

**Qualified applicants, submit your cover letter and CV to carla@epibone.com **

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.

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 0-3 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.

**Qualified applicants, submit your cover letter and CV to carla@epibone.com **

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.

Mechatronics Engineer

Company Overview & Position Description

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 a mechatronics engineer to help shape the next phase of bioreactor development and automation.
The mechatronic 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 be a creative problem solver who can ambitiously integrate many electromechanical components 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 mechatronics 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.

Essential Functions & Responsibilities

Design, assemble, test, and revise electromechanical systems
Review part specifications to identify components (sensors, motors, controllers, etc) for design criteria
Sketch and machine physical components using Solidworks, Mastercam, and CNC mill
Develop electrical drawings and assemble control systems
Program and troubleshoot PLC and microprocessor-based control systems
Perform other duties as assigned

Minimum Qualifications

Bachelor’s degree in mechatronics/mechanical engineering, electrical, or biomedical engineering with 1-3 years of work experience or Master’s degree with 0-2 years of work experience
Has experience with SolidWorks 3D design
Highly proficient in electrical design, data acquisition, and control systems using C, Python, Rockwell
Fundamental understanding of engineering design process, risk management, and good documentation practices
Ability to interpret and generate schematics, diagrams, and technical reports
Can operate independently, collaborate in a team, and easily adapt to rapidly changing project plan or timeline

Preferred Qualifications

Has experience with automation design, sensor integration, and human-machine interface
Proficient using Mastercam and operating CNC machinery
Knowledge of relevant standards for software and electrical safety

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.

**Qualified applicants, submit your cover letter and CV to carla@epibone.com **

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.

Executive Assistant

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 Executive Assistant to be the force that empowers the senior leaders of our Business Team.
The ideal candidate will have the ability to exercise good judgment in a variety of situations, with strong written and verbal communication, administrative, and organizational skills, as well as the ability to maintain a realistic balance among multiple priorities. Other important skills include, having the ability to work independently on projects with minimal oversight and guidance, from conception to completion, as well as being comfortable working under pressure to handle a wide variety of activities and confidential matters with discretion.

Essential Functions & Responsibilities

Provide sophisticated calendar management to the senior leaders of the Business Team, while prioritizing inquiries and requests, troubleshooting conflicts, and making judgements and recommendations to ensure smooth day-to-day engagements.
Complete a broad array of administrative tasks that include assisting with special projects; designing and producing complex documents, reports, and presentations; collecting and preparing information for meetings with staff and outside parties; composing and preparing correspondence; maintaining complex contact and investor lists; and making travel arrangements.
Schedules and attends Senior Leadership Meetings, in addition to coordinating the agenda, taking notes, and providing recaps of action items where appropriate.
Coordinate with the Office Manager to arrange and receive important guests that visit our office.
Assist in complicated follow-ups with contacts made by the Business Team to ensure timely outreach, and the continued cultivation of ongoing relationships.

Minimum Qualifications

Bachelor’s degree from an accredited university required.
Minimum of 5 years of experience reporting to and supporting executive level and/or C-suite individuals.
Excellent attention-to-detail, communication, prioritization, and record-keeping skills.
Extremely organized, self-managed, and knows how to “manage up”.
Comfortable with working traditional and non-traditional hours.
Proficient in standard Office programs like Word, PowerPoint, and Excel.
Ability to maintain a high level of integrity and discretion in handling confidential information.
Proactive problem solver who actively seeks opportunities for improvement and proposes actionable solutions.
Excellent judgement is essential.

Preferred Qualifications

Experience at a healthcare, biotech, life sciences, or venture capital organization a plus.
Experience in interacting with high-level individuals, investors, and fundraising activities.
Experience using CRM and marketing platforms.

Working Conditions/Physical Demands

Visa sponsorship is not available for this position.
No relocation assistance is provided for this position.

Employment Status

Full-time; exempt from overtime.

**Qualified applicants, submit your cover letter and CV to carla@epibone.com **

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.