Manufacturing Supervisor, Upstream

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 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</stro