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Manufacturing Technical Lead

4 months ago

Lexington, United States Genezen Full time

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 excellence in manufacturing processing as well as training others 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.

ESSENTIAL JOB FUNCTIONS

  • Oversee and execute Genezen's therapeutic manufacturing processes in compliance with GMP regulations, ensuring the highest standards of quality, safety, and efficiency.
  • Lead process optimization efforts, driving continuous improvement initiatives to enhance productivity, reduce waste, and minimize downtime.
  • Act as the point of contact for Tech Transfer and Collaborate with cross-functional teams to ensure smooth process transfer and scale-up from development to commercial production.
  • Collaborate with compliance and documentation teams to provide technical expertise and feedback during the revision of documents.
  • Conduct thorough process evaluations, identify areas for improvement, and implement corrective actions as needed.
  • Monitor and analyze key process metrics, such as yield, cycle time, and equipment utilization, to identify trends and drive process optimization strategies
  • Support Supervisors in generating BOMs and requesting materials for non-commercial products.
  • Ensure efficient use of material and equipment.
  • Act as backup for the monthly meeting lead for Tier 1 meetings and own the Continuous Improvement board at Tier 1.
  • Act as the primary contact for Supervisors regarding troubleshooting and issue resolution.
  • Should be well versed in all areas of the Manufacturing process
  • Create and follow-up on work requests in Blue Mountain.
  • Ensure accurate documentation, timely review, maintenance, and submission to Quality Assurance for stand-alone forms and logbooks in their respective area/process.
  • Communicate safety concerns and collaborate with EHS and Supervisors to drive resolution.
People:
  • Provide personnel feedback to leadership team.
  • Ensure staff compliance with all relevant SOPs, BPR's, SLR's and safety guidelines
  • Act as a role model (Lead by Example) and Act as a resource/SME for MFG staff
  • Ensure the use of safe work practices and behaviors
Training:
  • Develop and schedule supplemental training sessions in the pilot plant or idle rooms on the MFG floor.
  • Identify MFG technicians training needs and gaps, collaborating with the Training Coordinator to develop and deliver relevant training programs such as OJT training.
  • Coordinate training sessions with MSAT & Compliance teams to ensure MFG team members receive proper technical and compliance training.
  • Provide hands-on training and mentoring to manufacturing personnel, ensuring they possess the necessary skills and knowledge to execute processes accurately and efficiently.
  • Stay updated with industry advancements, new regulations, and best practices related to GMP manufacturing processes, and share relevant information with the team.
  • Develop and maintain MFG operators' qualification data such as Fill qual, VI qual, Vision acuity and media fill.
  • Work with quality assurance to develop and maintain visual inspection library and kit.
Quality:
  • Initiate deviations or investigations of various complexities and work with cross-functional departments to identify root cause.
  • Support MFG supervisors with Excursion assessments, CMS assessments, LE's and OOTs.
  • Create, update and maintain MFG Pre-Job brief guide.
  • Ensure staff compliance with all relevant SOPs, BPRs, SLRs, and safety guidelines.
  • Work with MFG supervisors and team leads to Implement appropriate corrective actions
  • Review GMP documentation daily and escalate as needed
SPECIAL JOB 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

HS Diploma and 10+ years related industry experience

Essential

BS or MS degree in Life Sciences/Engineering field with 5+ years of GMP Manufacturing experience

Desired

ON-THE-JOB EXPERIENCE

Prior leadership experience

Essential

Experience in a comparable position, in an industrial organization

Essential

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

Essential

Hands-on experience in writing and reviewing documentation

Essential

Experience in GMP manufacturing operations - USP, DSP, Buffer and DP

Essential

SKILLS / ABILITIES

Ability to apply systems thinking as part of a problem-solving

Essential

Demonstrates industrial empathy when working with stakeholders

Essential

Detail oriented and able to self-organize

Essential

Able to communicate in a professional way on diverse levels and channels

Essential

Takes the initiative to own and resolve issues

Essential

Good technical writing and oral communication skills

Essential

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment
  • Frequently required to work in a GMP clean room environment with personal protective equipment/aseptic gowning
  • Regularly required to work around equipment and typical utilities seen in pharmaceutical facilities
  • Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
  • Occasionally exposed to loud noise levels
  • Spending time on the floor during activity execution is required
Movement
  • Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; 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 25 pounds
  • Occasionally lift and/or move up to 40 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 principals.

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
  • Paid sick time
  • 9 observed holidays + 1 floating holiday + 1 volunteer day
  • 401(k) plan with company match up to 6% of salary, vested immediately
  • 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 museumto 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.