Manufacturing Supervisor - 2nd Shift (2:00-10:30pm)

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

With minimal supervision this individual will deliver leadership and excellence in manufacturing processing as well as scheduling to meet site demands. Oversees and executes floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. Ensures efficient use of material and equipment and assigns personnel as appropriate in the execution of day to day operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices, where appropriate, into Manufacturing.

This position is located in Lexington, MA and will supervise the 2nd shift which will operate M-F from 2:00-10:30pm. The Supervisor will report to the Director of Manufacturing and Compliance.

ESSENTIAL JOB FUNCTIONS

Supervise, train, and mentor the upstream, downstream, drug product, and banking (Cell/Virus) teams.

Create a high-performance that emphasizes strengths-based execution, accountability, open communication, people development, and continuous improvement.

Primary contact for troubleshooting and issue resolution or escalation

Create and follow up on work orders

Communicate/ coordinate day’s scheduling and staffing plan

Oversight and execution of all routine and critical operations (upstream, downstream, and cell/virus banking as well as commissioning and validation activities

Ensure documentation is complete, reviewed, and meets good documentation practices (forms, logbooks, solution records, batch records, etc.)

Responsible for floor inventory and communicating schedule changes as needed

Identify and support process changes/improvements or safety/ergonomic improvements.

Ensure work is carried out in a safe manner, take action on safety issues and risks

Ensure that the department is in a continuous state of readiness for production and GMP audits.

When needed, independently perform manufacturing of client's therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements

As a system owner of all manufacturing equipment, respond per on-call schedule to CMS alarms, including off-hours and weekends.

Oversee external GMP cleaning team's training and activities to ensure compliance with internal procedures.

JOB QUALIFICATIONS

Prior leadership experience in GMP manufacturing facility

Preferably work experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization

Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes, and procedures

Experience completing moderate to complex schedules

Hands -on experience in writing and reviewing the documentation

Experience in (bio)-manufacturing unit operations

Good writing and oral communication skills

The work schedule may require adjustments to support production activities

SPECIAL WORK REQUIREMENTS

Adaptability required as work schedule may change based on business needs

Criminal background check required

Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

Bachelor’s Degree in Life Sciences/Engineering

Desired

ON-THE-JOB EXPERIENCE

5-7+ years of cGMP experience

Desired

SKILLS / ABILITIES

Process-oriented way of thinking and working

Essential

Detail-Oriented

Essential

Self-organized

Essential

Able to communicate professionally on diverse levels and channels

Essential

Capable of taking the initiative when necessary

Essential

Flexible attitude in a challenging environment

Essential

Intrinsically motivated

Essential

Compensation:

The compensation range for this position is $105,000-$130,000 dependent upon experience level of the successful candidate.

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.