Company:  Confidential

Job Title: Director, R&D

Job Number: 30907

Location: Frederick, MD

Job Description

We are seeking a talented Director of R&D to fill a unique role leading our R&D department. The successful candidate will combine strong technical skills with product development experience and personnel leadership abilities to oversee and expand R&D programs. Key scientific strengths should include a highly analytical and quantitative approach to biochemical
and bioengineering systems, breadth of experience, and the ability to rapidly identify and solve technical problems. Required leadership qualities include excellent communication skills, an understanding of individual and team needs, and a commitment to fostering a positive, inclusive environment while pursuing aggressive timelines. Reporting directly to the Vice President of Operations, the Director of R&D will be responsible for guiding the R&D department to execute on product development plans by providing hands-on technical expertise and leadership. He/she will lead a team of scientists and engineers in areas including protein biologics, combination products, and bioscaffold device development. Working closely with executive leadership, this person will be responsible for driving the growth of our product development pipeline and the vision of our broad technology platform. This is a new role in a growing organization and our ideal candidate will possess the above qualities, have experience building and maintaining highly productive teams, and have the desire to learn and grow in responsibility. The candidate will possess the soft skills to inspire and lead colleagues in a highly collaborative, fast-paced setting while contributing to leadership of the organization.


• Apply scientific breadth of experience, creativity, and leadership to oversee the execution of multiple projects and initiation of new projects in the expanding R&D program
• Lead product development teams in the development of Class III combination product and 510(k) medical devices under Design Control. Provide hands-on technical, scientific, and project planning guidance to the R&D team
• Work with the executive team to develop strategic and tactical plans for R&D projects and product development projects including expansion of bioanalytical and bioengineering capabilities. Contribute to generation of new product pipeline ideas
• Identify technical, product, and timeline risks and well as key decisions and lead efforts to resolve issues quickly
• Collaborate with all cross functional teams including Regulatory, Quality, Clinical, and Manufacturing to prepare for product scale up for pre-clinical and clinical work. Contribute to the preparation of regulatory filings and provide support and oversight through the preclinical and FDA clinical trials process
• Work with and provide oversight as needed to technical leads at CROs and CMOs to bioanalytical characterization and manufacture of products
• Implement innovative approaches and best practices to R&D program. Develop procedures, processes, and approaches that assure the highest scientific rigor and analytical approach
• Provide mature leadership and guidance with the goal of building a highly functional and effective team, as well as mentoring individual employees as they grow along their own professional trajectories
• Develop and train staff to create a positive work culture and a high performing team
• Assure the safety of the laboratory team through understanding and adherence to laboratory safety precautions and proper use of personal protective equipment

Required Skills

• PhD in Biochemistry, Biophysics, Bioengineering, Biomedical Engineering, or a related field plus a minimum of 5-8 years of experience in industrial product development
• Strong scientific fundamentals and analytical background
• Demonstrated ability to lead multiple high priority projects simultaneously and pivot quickly based on project needs
• Demonstrated ability to prepare high quality reports/presentations and to deliver under pressure
• Experience with multiple of the following technical areas: protein biologics production and purification, surface immobilization of proteins, bioanalytical and biophysical characterization methods, design and manufacture of medical device product development (Class III desirable), and 3D printed, bioscaffold, or cell-based systems
• Strong working knowledge of product development under Design Control with proven track record of developing and launching products

• Understanding of ISO 13485, FDA 21 CFR 820, the cGMP for pharmaceutic products and CE is beneficial and CE is beneficial. IDE and PMA experience preferred
• Excellent interpersonal skills and the ability to work well with staff at all levels (from executives to junior team members). Proven experience hiring, mentoring and developing scientists and engineers
• Expert level ability with data analysis tools (Excel, GraphPad Prism) and presentation
tools (Word, Powerpoint)


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