About this opportunity
Genezen lists this Manufacturing Supervisor, Upstream opportunity in indianapolis, Indiana. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Manufacturing Supervisor, UpstreamPromote 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.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 departmentPrior leadership experience in GMP manufacturing facilityPreferably work experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organizationAbility to adhere to company internal and regulatory (EMA, FDA) policies, processes, and proceduresHands -on experience in writing and reviewing the documentationExperience in (bio)-manufacturing unit operationsGood writing and oral communication skillsThe work schedule may require adjustments to support production activitiesAdaptability required as work schedule may change based on business needsCriminal background check requiredOther duties as assignedBS in Biology, Microbiology, Chemistry, Virology, or any other relevant field of study - DesiredIn-depth knowledge of aseptic processing, GxP, cell culture, and bioreactor operation and troubleshooting - Essential4-6 years of related work experience in a GMP environment - Essential1 year of supervisory experience - DesiredDrug Substance experience with cell culture and upstream viral vector manufacturing - Strongly DesiredExperience using single use systems - DesiredDemonstrated interpersonal skills to build relationships, act as change agent, manage conflict, and adapt to rapidly changing organizational and business needs - EssentialAbility to manage multiple priorities - EssentialFrequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowningRegularly required to work around large machinery and typical utilities seen in pharmaceutical facilitiesOccasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shockOccasionally exposed to extremely loud noise levelsSpending time on the floor during activity execution (manufacturing, maintenance, construction, commissioning, and qualification) is requiredFrequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and armsOccasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawlFrequently lift and/or move up to 25 poundsOccasionally lift and/or move up to 40-50 poundsFrequently utilize close vision and the ability to adjust focusCorrected 20/20 vision to assist with visual inspection of Drug ProductsFrequently required to communicate by talking, hearing, using telephone and e-mailStrong communication skills to efficiently collaborate and coordinate within manufacturing and cross-functionalCommitted 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.Paid vacation days, amount based on tenurePaid sick time10 observed holidays + 2 floating holiday + 1 volunteer day401(k) plan with company match up to 6% of salaryShare Appreciation RightsChoice of several healthcare plansFSA and HSA programsDental & vision careEmployer-paid basic term life/personal accident insuranceVoluntary disability, universal life/personal accident insuranceAccidental Death & Dismemberment (AD&D) InsuranceNothing 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.
Worksite address
indianapolis, IN, 46201, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.