The Manufacturing Engineer will join our growing manufacturing team to be responsible for ensuring consistent production of industry leading affinity chromatography products at Avitide and drive the design and implementation of robust manufacturing processes to support the rapid growth of our product portfolio. Besides existing processes, the incumbent will also support the design and implementation of new manufacturing processes, including new chemistries, automation, and equipment expansion. Avitide is disrupting the cadence of commercialization for novel and high-performance biopharmaceutical affinity chromatography products. This role will enable the manufacture and supply of these essential technologies to Avitide’s biopharmaceutical partners enabling new and critical medicines that will positively impact human health.Responsibilities:
- Provide leadership and directly participate in all product manufacturing activities.
- Lead the design and implementation of new processes, capacity expansion and automation.
- Develop and implement solutions to any production challenges
- Issue and review all required documentation for product manufacturing, including SOPs.
- Define and monitor Quality performance indicators to evaluate production performance. Identify trends and execute root cause analysis, develop, and implement corrective action plans.
- Identify areas for improvement and drive initiatives to increase process robustness, reliability, efficiency, and product quality using LEAN 5S and Six Sigma methodologies.
- Oversee manufacturing equipment, including maintenance, to ensure functionality, suitability and compliance with Quality standards and regulations.
- Coordinate work with various contractors and service providers for design, hazard assessment, fabrication, installation, and verification procedures.
Education and Experience:
- Bachelor’s in chemical engineering, BioProcessing or Chemistry (or related field) with 5+ years’ experience in a manufacturing environment, preferably with one to two years GMP experience.
- Hands-on experience with designing, operating, and maintaining chemical equipment for stirred reactions and filtrations (15-100 L reactors) in a clean room environment (ISO 8 level).
- Hands-on experience with pneumatic and PLC systems. Experience with developing and implementing automation projects.
- Experience with process transfer from R&D to pilot scale manufacturing, as well as from pilot scale to manufacturing scale.
- Experience with AutoCAD or similar drawing software.
- Strong knowledge of MS Office, Minitab (or JMP).
- Experience with leading LEAN 5S initiatives.
- Sig Sigma Green belt with DOE experience preferred.
- Excellent communication skills and ability to thrive in an agile, team-oriented environment.
- Ability to provide evening and weekend support if necessary.
Avitide Cultural Qualities
- Actively contribute to our collaborative team culture
- Ability to work autonomously and effectively under broad corporate directives
- Agile and quick to adapt
- Excellent and timely communication skills
About Avitide LLC, A Repligen Company
- Avitide produces high-performance affinity chromatography solutions for the biopharmaceutical manufacturing industry. Avitide seeks qualified candidates to build upon their highly motivated and interdisciplinary team and add to the culture of rapid and continuous technology innovation.
- Avitide is a wholly owned subsidiary of Waltham, MA based Repligen Corporation, a global leader in bio-purification.
- Avitide's facility is located in Lebanon New Hampshire, minutes from Dartmouth College. The surrounding New Hampshire and Vermont areas are renowned for its quality of life, premier schools and outdoor activities including skiing, hiking, kayaking and biking.