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
Promote a safe working environment, training, and development of the manufacturing team; plan on-time execution of batch activities; deliver quality and safe viral vector products; and continuously improve manufacturing processes.
This position is located in Indianapolis, Indiana (City of Fishers) and will report to the Director of Manufacturing.
ESSENTIAL JOB FUNCTIONS
- Provide leadership, coaching, and mentoring of Upstream manufacturing personnel.
- Oversee and execute Vector Upstream Manufacturing activities including the scheduling of resources, material staging, equipment preparation, batch execution, cleaning/sanitization, inventory transactions, and batch record review.
- Provide on the floor training and support for upstream manufacturing operations for clinical viral vector batches.
- Hire, coach, and develop Manufacturing team members, including performance management and periodic reviews.
- Strong knowledge of cGMP and GDP requirements for Drug Substance Manufacturing (Viral Vector Manufacturing preferred).
- Strong technical knowledge of both adherent and suspension cell lines including cell thawing, scale-up, bioreactor inoculation, transfection, harvest, and clarification.
- Preferred knowledge and experience with the use and troubleshooting of Cytiva XDR 50L, Cytiva XDR 500L, Univercells Scale-X Carbo, and Cytiva iCELLis 500 bioreactors.
- Monitor and report on area performance, identifying opportunities for improvement and implementing process improvements.
- Design, implement, maintain, and continuously improve vector manufacturing systems, policies, procedures, and programs that ensure compliance to company and regulatory body standards for Quality and EHS.
- Identify and mitigate risks in Manufacturing operations that could negatively impact product and personnel safety.
- Manage the Manufacturing Production system including but not limited to personnel development, problem solving, investigation of deviations, root cause analysis, CAPAs, Change Controls, 6S, etc.
- Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the Manufacturing department
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
- 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
BS in Biology, Microbiology, Chemistry, Virology, or any other relevant field of study
Desired
In-depth knowledge of aseptic processing, GxP, cell culture, and bioreactor operation and troubleshooting
Essential
ON-THE-JOB EXPERIENCE
4-6 years of related work experience in a GMP environment
Essential
1 year of supervisory experience
Desired
Drug Substance experience with cell culture and upstream viral vector manufacturing
Strongly Desired
Experience using single use systems
Desired
SKILLS / ABILITIES
Demonstrated interpersonal skills to build relationships, act as change agent, manage conflict, and adapt to rapidly changing organizational and business needs Essential Ability to manage multiple priorities Essential
Work Environment:
- Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
- Regularly required to work around large machinery 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 extremely loud noise levels
- Spending time on the floor during activity execution (manufacturing, maintenance, construction, commissioning, and qualification) is required
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 25 pounds
- Occasionally lift and/or move up to 40-50 pounds
Vision:
- Frequently utilize close vision and the ability to adjust focus
- Corrected 20/20 vision to assist with visual inspection of Drug Products
Communication:
- Frequently required to communicate by talking, hearing, using telephone and e-mail
- Strong communication skills to efficiently collaborate and coordinate within manufacturing and cross-functional
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
- 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.
