Biomedical Process Engineer

Watertown, MA
Research & Development
Full-time
Are you interested in an engaging job and making a big impact in patient's lives?


Company Summary:  
Windgap Medical, Inc. is a rapidly-growing, private pharmaceutical company developing injection devices for self-administration and associated drugs. Windgap’s first product is a wet/dry autoinjector delivering a proprietary epinephrine formulation for the treatment of anaphylactic shock. Long-term, Windgap will leverage its injection platform for additional therapies.
 
Job Description:
Windgap is looking for a hands-on Biomedical Process Engineer to support the effective and efficient development and release of our products. The candidate will be joining Windgap’s Advanced Programs Team to develop next-generation medical countermeasures & drug delivery devices. The candidate should be a flexible, self-starter, who is effective in situations where s/he is held accountable in a multi-stakeholder environment. The candidate should also be comfortable investigating and executing a wide variety of tasks. The position is focused upon researching and developing next generation products based on its commercial autoinjector platform. Windgap leverages a team of Contract Manufacturing Organizations (CMOs) for all manufacturing operations and Contract Research Organizations (CROs) for development support. 

The candidate will:

    • Report to Windgap’s VP of Product Development
    • Operate HPLC to analyze samples generated by delivered dose uniformity (DDU) and blend uniformity (BU) tests
    • Operate lyophillization system, optimize lyophillization cycle parameters for various drugs (non-GMP)
    • Operate and optimized powder and liquid filling equipment (non-GMP) for various powder and liquid drugs, diluents, and device configurations
    • Develop and document standard operating procedures (SOPs) for R&D equipment and processes
    • Prepare HPLC reagents, sample dilutions, and follow basic formulation chemistry procedures
    • Maintain an accurate and complete laboratory notebook
    • Maintain laboratory cleanliness, supplies, personal protective equipment (PPE) and chemical inventory
    • Adhere to laboratory safety practices and protocols
    • Conduct monthly laboratory safety inspections and maintain laboratory MSDS
    • Develop and replicate HPLC methods to assay various novel drugs and chemistries currently in Windgap’s development pipeline
    • Ensure filling processes & procedures are in compliance with various regulatory standards including USP, ISO, ASTM and FDA guidance
    • Translate SOPs, process know-how, and machine parameters to commercial CMO systems and staff
    • Contribute to the early-stage chemistry, manufacturing, and controls (CMC) development for liquid and powder drug filling of parenteral drug products
    • Work with Lead Test Engineer to conduct autoinjector dose accuracy tests
    • Establish individual and team goals consistent with overall project and company goals
    • Support reliability, design, and manufacturing engineers as the product advances from early development to product maturity
    • Be capable of working both independently and in a team, while being flexible, self-motivated, curious, and willing to drive change in the drug delivery market
    • Will be experienced with disposal of laboratory waste in a manner consistent with internal, state, and federal guidelines
    • Preferably, have experience with working with outside chemical testing companies

Relevant experience:

    • BSME, BSBME or similar required. 2-5 years of working experience with medical devices preferred. 
    • Experience working in a laboratory environment, operating sensitive analytical equipment such as UV/Vis spectroscopy, microbalance, and High-Performance Liquid Chromatography (HPLC)
    • Preferably, experience performing HPLC analysis with, more preferably, method development for the HPLC
    • Proven experience writing process SOPs and test reports
    • Familiarity with ISO 13485 and FDA 21 CFR Parts 820, 210/211 standards
    • Preferably experience with the safe handling and filling parenteral products such as syringes, needles, plungers, and related seals, barrels, lubrication, and elastomeric coating technologies
    • Comfort with all phases of product development lifecycle including concept generation, design, rapid prototyping, manufacturing, verification & validation, qualification, and commercialization
    • Experience with risk management of manufacturing process design by pFMEA
    • Preferably, experienced with drug/device combination product development
    • Preferably, experienced with ISO 11608 and 14971 standards
    • Preferably, experienced with hardware products in an FDA or other regulated industry
    • Experience working on US Government contracts is beneficial
    • Experience with MS Office, including email, word processing, spreadsheets, and presentation tools
    • Some travel may be required
Windgap Medical, Inc. offers a competitive benefits package including, medical, dental, disability, life insurance, 401K savings plan and is EOE/M/F/D/V employer. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Thank you for considering Windgap Medical. We will review your qualifications and contact you if we would like to talk more.

Sincerely,

The Windgap Medical Team