Manager/Sr. Manager, Process Engineering

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.

Adaptability required as work schedule may change based on business needs

Criminal background check required

Other duties as assigned

EDUCATION/CERTIFCATIONS/LICENSES

Education Level: B.S. in Chemical, Biomolecular, or Biomedical Engineering

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.

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.

Essetial

Compensation:

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

Work Environment

Regularly sit for long periods of time

Movement

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

Lifting

Frequently lift and/or move up to 10 pounds

Rarely lift and/or move up to 25 pounds

Vision

Frequently utilize close vision and the ability to adjust focus

Communication

Frequently required to communicate by talking, hearing, using telephone and e-mail

GENEZEN'S CURES VALUE-BASED COMPETENCIES

C ommitted to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

U rgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

R esilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success.

E xecute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals.

S olutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

Paid vacation days, amount based on tenure

Paid sick time

10 observed holidays + 2 floating holiday + 1 volunteer day

401(k) plan with company match up to 6% of salary

Share Appreciation Rights

Choice of several healthcare plans

FSA and HSA programs

Dental & vision care

Employer-paid basic term life/personal accident insurance

Voluntary disability, universal life/personal accident insurance

Accidental Death & Dismemberment (AD&D) Insurance

ADDITIONAL DETAILS

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.