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Genezen
Lexington, MA
Source: Genezen careers · View original posting
From Genezen's posting. “We” and “our” refer to the employer.
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.
WORKING AT GENEZEN
Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
JOB SUMMARY
The Process Engineering Manager/Sr. Manager is responsible for leading the process engineering department at Genezen’s Lexington facility. The incumbent will act as the key decision maker implementing program enhancements and overseeing equipment onboarding and process improvements. The candidate will establish goals and priorities their staff and act as the primary liaison between both internal customers and external service providers. The Process Engineering Manager/Sr.
Manager will represent Engineering as the subject matter expert for all engineering related topics during client facing project meetings and be responsible for the department deliverables.
JOB RESPONSIBILITIES
Represent department at client and cross functional meetings serving as the key stakeholder for all process engineering related topics.
Drives necessary equipment, control system, and facility improvement projects, providing oversight of design, construction, testing, and turnover with responsibility for schedule, budget, and overall project performance.
Provide technical input for product tech transfers, evaluation of process requirements versus facility capabilities.
Provide technical support and analysis for the resolution of deviations, investigations, and process issues.
Works independently to develop department procedures, standards, and specifications.
Manage and mentor engineering staff providing clear direction, expectations and goal setting.
Maintain team metrics related to on-time delivery and provide routine status updates to management.
Perform goal setting and period performance reviews of direct reports in alignment with corporate objectives.
Essential
ON-THE-JOB EXPERIENCE
Years of Experience: 8+ years of relevant working experience including 3 years of management experience in a comparable position (similar type of work, similar group dynamics)
Essential
SKILLS/ABILITIES
In-depth operational knowledge of single-use process equipment such as bioreactors, chromatography skids, UF/DF and mixing systems. Experience with fill-finish equipment is highly desirable.
Experience troubleshooting support utilities such as WFI, Pure Steam generators and compressed gas systems.
Must be able to work on complex problems in which analysis of situations or data requires and in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Incumbent will be required to carry a cellular phone and be on call to support manufacturing operations.
A valid driver’s license is required for travel to vendor and / or consultant offices.
Travel to accommodate vendor visits, domestic and international may be required.
Experience with pharmaceutical / biopharmaceutical equipment commissioning, validation, and performance monitoring
Proven experience and proficiency troubleshooting process and process support system issues.
Essetial
Compensation
The compensation range for this position is dependent upon experience level of the successful candidate. The ranges are as follows:
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
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