Senior Manufacturing Specialist

1 week ago

Lexington, Kentucky, United States Genezen Full time
Job Overview

The field of gene therapy is expanding rapidly, and Genezen is dedicated to fulfilling the precise requirements of our clients. We specialize in process development, the production of GMP viral vectors, and cell transduction for gene and cell therapy clinical trials, proudly contributing to the advancement of new treatments.

WORKING AT GENEZEN

At Genezen, we strive to create an environment where employees feel valued and empowered. We encourage our team members to be innovative and collaborative problem solvers, committed to overcoming the challenges that come with being part of a dynamic and growing organization. Every individual plays a crucial role in our success, and we are committed to making Genezen a fulfilling workplace.

POSITION SUMMARY

The Manufacturing Technician will execute all necessary process steps and in-process controls, collaborating closely with Process Development, Quality Control, Quality Assurance, Engineering, and Validation teams. This role involves performing both routine and non-routine manufacturing tasks with minimal supervision, including operations in Cell Culture, Purification, and Equipment Preparation. The technician will operate production equipment in accordance with Standard Operating Procedures (SOPs) for the creation of clinical and/or commercial products, while also supporting engineering and validation efforts.

KEY RESPONSIBILITIES

The successful candidate will independently manage the manufacturing of Genezen's therapeutic products, ensuring compliance with the highest industrial and GMP quality standards. Key responsibilities include:

  • Participating in daily operational meetings
  • Conducting regular walkthroughs to maintain a safe and compliant work environment
  • Ensuring the production area is organized and stocked with necessary supplies
  • Demonstrating proficiency in aseptic techniques
  • Performing troubleshooting in accordance with SOPs
  • Executing both routine and non-routine production tasks as per the manufacturing schedule
  • Communicating any schedule-impacting events to management
  • Documenting operations in accordance with Good Documentation Practices (GDP) in Batch Production Records (BPR), Solution Records (SLR), and Logbooks
  • Reviewing documentation for accuracy
  • Coordinating with cross-functional teams for sample submissions and process monitoring
  • Ensuring all work is performed safely and reporting any safety concerns
  • Providing training as a Qualified Trainer
  • Maintaining current training records for relevant processes
  • Availability to work during holidays as required

The technician will also oversee equipment management and support facility-related projects by:

  • Acting as a subject matter expert for process improvement initiatives
  • Performing routine cleaning and maintenance of equipment
  • Assembling and disassembling process equipment as needed
  • Standardizing equipment operations
  • Facilitating product changeover activities
  • Supporting equipment and process qualifications when necessary
  • Escalating work requests to senior or lead technicians as required

COLLABORATIVE EFFORTS

In collaboration with supervision, the technician will:

  • Request new logbooks as necessary
  • Propose revisions to documentation and support continuous improvement efforts
  • Advance process improvement suggestions as appropriate
  • Develop and maintain a personal development plan
  • Conduct annual self-assessments of performance

QUALIFICATIONS AND SKILLS

  • A high school diploma with 4-6 years of relevant cGMP industry experience, or an Associate's Degree in Life Sciences/Engineering with 3 years of cGMP experience, or a Bachelor's degree in Life Sciences/Engineering with 1-3 years of cGMP experience
  • Experience in a similar role within an industrial setting is preferred
  • Ability to comply with internal and regulatory policies (EMA, FDA)
  • Hands-on experience in documentation processes
  • Familiarity with (bio)-manufacturing unit operations (USP and/or DSP)
  • Strong written and verbal communication skills
  • Ability to work within established procedures and scientific methods
  • Physical capability to lift up to 40 lbs

CORE COMPETENCIES

  • Process-oriented mindset
  • Attention to detail
  • Self-organized and proactive
  • Effective communication across various levels
  • Initiative in problem-solving
  • Adaptability in a challenging environment
  • Intrinsic motivation to excel

PHYSICAL REQUIREMENTS

While performing the duties of this position, the employee must meet the following physical demands:

  • Regularly work around pharmaceutical equipment and utilities
  • Occasionally be exposed to moving mechanical parts, high places, and hazardous materials
  • Occasionally work outdoors and on rooftops
  • Spend significant time on the production floor during operational activities

GENEZEN'S CULTURE AND VALUES

Genezen is committed to scientific excellence, urgency in patient care, resilience in operations, and integrity in execution. We strive to be solution-driven partners, dedicated to advancing healthcare through innovation and collaboration.

BENEFITS

  • Paid vacation and sick leave
  • Holidays and volunteer days
  • 401(k) plan with company match
  • Healthcare plan options
  • Flexible spending accounts
  • Dental and vision coverage
  • Employer-paid life insurance
  • Voluntary disability and additional insurance options

ADDITIONAL INFORMATION

  • This job description does not restrict management's right to assign or reassign duties at any time.
  • A criminal background check is required for this position.
  • Genezen is an Equal Opportunity Employer and participates in EVerify.
  • Genezen welcomes all qualified candidates eligible to work in the United States.

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