Product Development Scientist

WHO WE ARE
Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of Biology and Orthopedic tissue repair.

Our lead therapeutics are in the following indications:

• Spinal Fusion
• Long Bone Repair
• Osteochondral Repair
• Dental and Facial Bone Repair

We are an innovative, fast-paced team that is advancing a diverse array of translational research projects.

POSITION SUMMARY
We are seeking a talented Product Development Scientist with experience developing products based on protein biologics and/or devices that incorporate biomolecules. The Scientist’s primary responsibility will be to work in an interdisciplinary team and drive product development programs by planning, executing, and analyzing experiments and conducting product development activities. This laboratory-based position will involve a diverse set of activities including protein and device characterization, bioanalytical and QC test method development, bioengineering, and combination product development. The Scientist will communicate results within the R&D team and to senior management and will troubleshoot issues that impact data quality and project timelines.

The successful candidate will possess strong technical skills, breadth of knowledge, creativity, and will be highly motivated. The candidate will be detail-oriented and have a proven ability to multi-task and pivot quickly based on project priorities. They will have excellent interpersonal skills and the ability to work well with staff at all levels in a highly collaborative, fast-paced setting while contributing to leadership of the organization.

If you are driven to contribute in an exciting and dynamic environment, we encourage you to apply now!

RESPONSIBILITIES

• Independently design, plan, execute, and analyze studies associated with biodevice development, manufacturing, and QC in support of product development, preclinical, and clinical programs
• Take initiative to propose viable solutions to technical problems and make educated recommendations for next steps
• Conduct a wide variety of biochemical and analytical tests and protein binding assays
• Develop new methods for characterization and analysis of novel biodevices
• Closely coordinate with team members to plan and execute product development activities under design control with minimal guidance
• Contribute to project planning and product innovation
• Provide guidance, coaching, and leadership to staff and colleagues as needed
• Coordinate with and oversee the work of service providers including contract manufacturers and/or contract research organizations to deliver on project goals
• Understand and adhere to laboratory safety precautions and proper use of personal protective equipment
• Prepare technical reports to summarize data and document experimental conclusions
• Communicate project status, roadblocks and results to supervisors and managers, identify risks and lead efforts to resolve issues quickly

QUALIFICATIONS

• BA/BS in Biochemistry, Biophysics, Bioengineering, Biomedical Engineering, Chemistry, Biology, or a related field with 7 years of product development experience or PhD with a minimum of 2 years of experience in industrial product development
• Analytical background and strong scientific fundamentals
• Solid experience working with and characterizing proteins, preferably experience working with systems where proteins are immobilized to surfaces
• Extensive experience with bioanalytical / biophysical characterization methods, bioassays / protein binding assays, and design and manufacture of biodevices and bioscaffolds (or some combination of these)
• Experience conducting product development under design controls; experience with GLP or GMP is desirable
• Training in and experience with Biosafety Level 2 (BSL-2) techniques is preferred
• Highly proficient with data analysis tools (Excel, GraphPad Prism) and presentation tools (Word, Powerpoint)
• Demonstrated ability to multitask and pivot quickly based on project needs

PHYSICAL DEMANDS

• 75 % of the day may be spent working in the lab
• Able to work at heights above four feet for certain tasks.
• Ability to lift up to 40 lbs
• Ability to work in a laboratory with chemicals and biochemicals and perform Biosafety Level 2 work

POSITION LOCATION:

• This is a full-time position, based at Theradaptive’s headquarters in Frederick, Maryland.