Position Summary

EpiBone is a clinical stage company that develops revolutionary tissue engineered products for skeletal defect repair. The company is recruiting a Tissue Manufacturing Specialist who will use cell and tissue culture techniques to create clinical grade medical products under cGMP conditions. This position offers a challenging and unique opportunity to work at an early stage company, and to support the clinical translation of regenerative therapies.

Position Activities

• Work in a highly-regulated collaborative team environment to perform cGMP manufacturing of clinical grade tissue engineered medical products.
• Culture primary human cells, perform 3D tissue culture, and prepare reagents per standard operating procedure (SOP).
• Maintain batch records, review cGMP data, and clearly document all manufacturing activities (including deviations, change controls, and corrective actions).
• Execute applicable documentation with minimal supervision and oversight.
• Attend relevant meetings to present, discuss, and evaluate manufacturing progress and scientific literature.
• Monitor, place orders, and re-stock inventory as necessary.
• Maintain calibrations and preventative maintenance of cGMP manufacturing equipment.
• Perform other related manufacturing, scientific, and administrative activities as assigned.

Minimum Requirements

BS degree in biology, biomedical engineering, and/or related fields with 1-3 year(s) of adherent cell culture experience.

Highly Desired Requirements

Prior experience working in cGMP manufacturing, cleanroom, and large-scale cell culture a plus.

Qualifications

• Experience with general lab safety, and aseptic techniques.
• Must be able to execute and develop written SOP instructions.
• Excellent critical thinking and decision-making skills.
• Produce work that is accurate and detailed.
• Demonstrate effective written and verbal communication skills.
• Strong organizational skills with high attention to detail.
• Must be able to work independently, as part of a team, and cross-functionally.
• Ability to work extended and/or non-traditional hours, as well as occasional weekends.
• Proficient in Microsoft Excel, PowerPoint, and Word.

Working Conditions/Physical Demands

• Ability to lift 25lbs or more on a regular basis.
• Must be able to stand for long periods of time.
• No relocation assistance is provided for this position.
• Visa sponsorship is not available for this position.

Schedule

Full-time

Overtime Status

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: Submit your cover letter and CV for consideration to: carla@epibone.com**