Manager/Sr. Manager, Process Engineering
Genezen
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Job summary
GENEZEN in Lexington, MA is seeking a Manager/Sr. Manager of Process Engineering to lead the department, drive equipment upgrades, and oversee process improvements for GMP viral vector manufacturing. You will represent Engineering in client meetings and guide project execution from design through turnover.
You will manage staff, align goals with corporate objectives, and ensure on-time delivery while maintaining quality and safety standards in a fast-growth biopharma setting.
Qualifications
- B.S. in Chemical, Biomolecular, or Biomedical Engineering.
- Essential 8+ years of relevant experience including 3 years of management experience.
- Experience with single-use process equipment and process validation is preferred.
Responsibilities
- Represent department in client and cross-functional meetings as key stakeholder.
- Drive equipment, control system, and facility improvement projects within schedule and budget.
- Provide technical input for product tech transfers and deviations resolution.
- Mentor engineering staff and set team goals and performance reviews.
Skills
Education
Tools
Job description
Lexington, MA
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 GENEZENManypeople 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 SUMMARYThe 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.
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
Education Level: B.S. in Chemical, Biomolecular, or Biomedical Engineering
ON-THE-JOB EXPERIENCEYears 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.
- Excellent communication, interpersonal, teamwork, and leadership skills
- Must be capable of multi-tasking and performing assignments that have loosely defined objectives which require investigation of numerous variables
- Ability to apply knowledge of multiple engineering disciplines to evaluate and develop solutions for operational issues
- Must be able to plan, coordinate, perform, and document work with minimal supervision
- Proficiency with Microsoft products and ability to learn additional applications as needed
- 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.
The compensation range for this position is dependent upon experience level of the successful candidate. The ranges are as follows:
Manager- $130,00-$150,000
Sr. Manager- $150,000-$170,000
- Regularly sit for long periods of time
- Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
- Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
- Frequently lift and/or move up to 10 pounds
- Rarely lift and/or move up to 25 pounds
- Frequently utilize close vision and the ability to adjust focus
- Frequently required to communicate by talking, hearing, using telephone and e-mail
Committed to Science
We are committed toscientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
- Paid vacation days, amount based on tenure
- 401(k) plan with company match up to 6% of salary
- Choice of several healthcare plans
- FSA and HSA programs
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- This position requires a criminal background check.
- Genezen is an Equal Opportunity Employer.
- Genezen participates in EVerify.
- Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
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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