Product Development Analyst

The Product Development Analyst will contribute to all aspects of new product development and product life cycle management at Alcresta. This position offers the opportunity to develop new enzyme- based products that leverage Alcresta’s core enzyme immobilization technology and expand existing medical device capabilities.  This role will have a direct impact on the Alcresta pipeline offering significant opportunities for career growth and participation in cross-functional development teams.

Primary Responsibilities:

Technical

• Design, plan, and execute bench experiments to advance product development objectives.
• Perform produce specific use/performance tests, enzymatic and plate-based assays, HPLC, GC, titration assays, viscometry, enzyme immobilization, and microscopy.
• Collaborate effectively with engineering team for device optimization/development.
• Provide insight for in situ and pre-clinical device studies.
• Develop new analytical test methods and enzymatic assays.
• Execute test method qualifications, as well as verification and validation testing to support medical device development and regulatory filings.
• Identify, evaluate and implement new technologies as required.
• Technical troubleshooting as needed.

Oral/Written Communication

• Write verification and validation rationales, test strategies, and applicable protocols.
• Analyze data and prepare clear, concise summaries and presentations to communicate results.
• Cross functional collaboration with manufacturing, engineering, marketing and quality groups to generate design control documentation for new product development.
• Effectively communicate data and results in cross-functional project team meetings.
• Manage relationships with CROs for external testing as needed.

Education and Experience:

• B.S/M.S. in biotechnology, engineering, chemistry or equivalent.
• 1-3 years of work experience in biotechnology or medical device industry is desired.
• Prior technical writing (publications, protocols, reports) experience is desired.

Key Skill and Competencies:

• Strong team player, results-oriented, willingness to work in a start-up style environment, including a “roll-up-the-sleeves” attitude to perform diverse tasks necessary (and multi-tasking) to achieve objectives.
• Highly motivated, flexible and enjoy working in a team-based environment with a strong interest in the development of new products, medical devices.
• Strong analytical, quantitative and technical writing and presentation skills.
• Ability to work independently and to concisely summarize and present results.
• Self-motivated and organized.
• Proficiency with Microsoft Office tools (Outlook, Word, Excel, PowerPoint, etc.) is required.
• Strong attention to detail.

Additional Job Requirements:

• Travel <10%
• Location - Waltham, Massachusetts