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

Genezen; Lexington (MA); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Manufacturing Supervisor for the 2nd shift. This role involves leading teams in a fast-paced environment, ensuring compliance with safety and quality standards while driving continuous improvement. The ideal candidate will have a strong background in GMP manufacturing and a passion for fostering a collaborative and innovative workplace. Join a dynamic team dedicated to advancing gene therapy and making a meaningful impact on healthcare. This position offers the opportunity to contribute to groundbreaking therapies while enjoying a supportive and rewarding work culture.

Benefits

Paid vacation days

401(k) plan with company match

Choice of healthcare plans

FSA and HSA programs

Employer-paid life insurance

Voluntary disability insurance

Qualifications

• 3-5+ years of cGMP experience required.
• Strong leadership skills in a manufacturing environment.

Responsibilities

• Supervise and mentor teams in manufacturing processes.
• Ensure compliance with safety and GMP standards.
• Manage scheduling and staffing for production.

Skills

Leadership in GMP manufacturing

Problem-solving

Communication skills

Process-oriented thinking

Detail-oriented

Adaptability

Education

Bachelor’s Degree in Life Sciences/Engineering

Job description

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

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 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 environment 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 uniQure’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.

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

Bachelor’s Degree in Life Sciences/Engineering.

ON-THE-JOB EXPERIENCE

3-5+ years of cGMP experience.

SKILLS / ABILITIES

Process-oriented way of thinking and working.

Detail-Oriented.

Self-organized.

Able to communicate professionally on diverse levels and channels.

Capable of taking the initiative when necessary.

Flexible attitude in a challenging environment.

Intrinsically motivated.

• 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

Committed to Science
We are committed to scientific 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 principles.

Solutions 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.
• 401(k) plan with company match up to 6% of salary, vested immediately.
• Choice of several healthcare plans.
• FSA and HSA programs.
• Employer-paid basic term life/personal accident insurance.
• Voluntary disability, universal life/personal accident 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.