Vision Insurance Jobs in INDIANAPOLIS, Indiana
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Director of Business Development (Remote)
Company: Genezen Laboratories
Location: Indianapolis, IN
Posted Oct 09, 2023
This role requires a comprehensive understanding of the gene and cell therapy market space, viral vector process development and manufacturing technologies, and the drug development regulatory environment, as well as a demonstrated ability to influence positive outcomes without direct reporting authority.ESSENTIAL JOB FUNCTIONS Understand the overarching business development strategy, sales processes, structure, and desired customer experienceIdentify and engage with new prospective clients using sources such as databases, publications, market analysis, trade shows, and contactsGenerate new leads, contact decision-makers, and screen and qualify potential new business opportunitiesLead and work closely with the commercial and technical teams to progress potential customers through the sales process (technical calls, RFP, proposals, visits, contracting, etc. 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. )Lead customer meetings/business due diligence evaluationsAdvise on proposal generation for assigned opportunities and accounts, including detailed RFP responses and proposal development, including inputs from scientific and operations teamsWork with commercial leadership to drive negotiation of agreements and achieve sales objectivesDocument pipeline effectively in CRM, maintain prospect databases, and provide forecasting dataContribute to the implementation of marketing initiatives, including providing market information, distributing materials, and attending trade showsMonitor and evaluate industry trends and customer drivers as well as internal capabilities and technologiesMeet regularly with management and stakeholders to discuss updates and potential impact to strategyDemonstrate exemplary skills in leadership, communication, and account/relationship management while maintaining extremely high quality and efficiency standardsSPECIAL JOB REQUIREMENTSAdaptability required as work schedule may change based on business needs, including flexibility for different time zonesCriminal background check requiredOther duties as assignedKNOWLEDGE, SKILLS AND EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESEssential/DesiredBS in Biology, Biochemistry, or ChemistryEssentialAdvanced Degree in the life sciences and/or businessDesiredON-THE-JOB EXPERIENCE 5+ years of sales/technical experience or client relationship experience, ideally in a bio-manufacturing or CDMO environmentEssentialExperience with CRM SoftwareEssentialBiologics experience specifically with gene and cell therapiesDesiredExperience within a regulated environment and ability to interact effectively with process development and quality assurance/quality control professionalsDesiredExperience with negotiating long-term commercial contracts; strong negotiation skillsDesiredSKILLS / ABILITIES Strong influencing skills and attention to detail with the ability to manage multiple competing priorities and projects across functionsEssentialTact and diplomacyEssentialHigh levels of initiative, self-motivation, and energy with an ability to work well within a commercial teamEssentialHighly organized with an ability to manage complex information and work effectively to deadlinesEssentialAmbitious, performance-oriented, and able to work independentlyEssentialPHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands:Work EnvironmentSit for long periods of timeMovementRepeated hand movements, typing, use of keyboard and mouseFrequently 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 crawlLiftingFrequently lift and/or move up to 10 poundsOccasionally lift and/or move up to 25 poundsVisionFrequently utilize close vision and the ability to adjust focusCommunicationFrequently required to communicate by talking, hearing, using telephone and e-mailGENEZEN'S VALUE-BASED COMPETENCIESGrowth MindsetBelieve that skill is developed through dedication and hard work.Intelligence & talent are just the starting point.Mistakes are valuable lessons, not shameful indictments.FlexibilityAdapt rapidly to a quickly changing, CDMO environment.Respond by constructively creating & impacting opportunity through active participation.Team FocusWork together; succeed together; fail together.IntegrityDo the right thing, on time, every time.Speak up when needed.Exercise respect.Inclusion Embrace the unique viewpoint of each individual.Join the ongoing journey to a more inclusive workplace and community where we all help each other get better.GENEZEN'S BENEFITSPaid vacation days, amount based on tenurePaid sick time9 observed holidays + 1 floating holiday + 1 volunteer day401(k) plan with company match up to 6% of salary, vested immediatelyShare 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) InsuranceADDITIONAL DETAILSNothing 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 is located in Fishers, Indiana.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 is located in Fishers, Indiana, a suburb of Indianapolis. Every employee contributes to the success of the company and you can be part of that team.JOB SUMMARYWork closely with the Commercial team to implement Genezen’s overall business development strategy. That includes identifying and engaging new prospective CDMO clients, coordinating client visits and proposals, negotiating agreements, maintaining a relationship with current clients, and achieving sales objectives. Fishers was named the 1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Genezen is different. 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 GENEZENMany people have worked in environments where you feel like just another nameless part of an enormous machine. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work.
Market Risk Analyst I - Hybrid
Company: Federal Home Loan Bank of Indianapolis
Location: Indianapolis, IN
Posted Sep 29, 2023
FHLBank Indianapolis, a cooperative bank serving Indiana and Michigan, offers a flexible hybrid workforce model, competitive pay, tuition reimbursement, student loan repayment assistance, and a comprehensive benefits package. The ERM Market Risk Analyst I position involves implementing, testing, and operating market risk processes, producing risk reports, and assisting in the improvement and maintenance of the PolyPaths risk modeling environment. The ideal candidate holds a Master's degree in a quantitative field, has 1-2 years of quantitative risk analysis experience, and possesses strong analytical and communication skills.
Tea and Flavor Systems Technologist
Company: FFP
Location: Indianapolis, IN
Posted Oct 01, 2023
Maintain laboratory equipment. Collaborative. Maintain knowledge of beverage client's strategies, brands, and products. Multitasks. Teamwork- Work well with the varied teams within FFP. Ability to lift up to 25 lbs Benefits Medical, Dental, Vision, and Prescription Drug Insurance on Day 1 Health and Wellness Incentives 10 Days of PTO 10 Paid Company Holidays 5 Personal Days 401(k) Health Savings Account (H.S.A.) Ability to stand for prolonged periods of time while working in the lab Ability to work in a production environment. Gathering product or ingredient-related information from vendors Maintain a safe and clean work environment by complying with procedures, rules, and regulations and Good Manufacturing Practices Develop beverage systems which showcase FFP flavors, ingredients, and technologies as integrated solution systems. Requirements MINIMUM REQUIREMENTS: 5 years of experience with bachelor's degree in Food Science or related science. Maintain laboratory and sample inventory of ingredients and supplies.
Account Executive (AE) Inbound - US
Company: Hubstaff
Location: Indianapolis, IN
Posted Oct 09, 2023
For this particular position, we are looking for someone living in the US, giving preference to someone living in one of the following states: Illinois, Indiana, Minnesota, Washington, Oregon, New Mexico, Florida, Nevada, Arizona,Texas, Utah, Georgia, or Maryland. So while 2020 had us virtually meeting because of the pandemic, we met in Portugal (in 2019), Mexico (in 2018), and we had our first in-person retreat after Covid-19 in the Dominican Republic (Feb 2022). In addition, you can read more about us on our website and learn more about our history and work philosophy on our blog. We are giving preference for a professional located in one of the following states: Illinois, Indiana, Minnesota, Washington, Oregon, New Mexico, Florida, Nevada, Arizona,Texas, Utah, Georgia, or Maryland. Main benefits offered to our employees in the US: 25 PTO days/year + health insurance + generous maternity and paternity leave + equipment and self-growth annual bonuses + 100% remote work + working hours flexibility + 401k, among other benefits. Annual Salary: USD $120,000 OTE (USD 40/Hour ($84,000 Base) + $36,000 Commissions) Commissions are uncapped, so you can earn well above the $120K mark. You can find more about Hubstaff and what it's like working with us here. Our current average AE quota attainment year-over-year is 126%. We are scaling our sales team, so you'll be successful if you are able to onboard yourself quickly and have a go-getter, hands-on attitude The drive and energy to manage a large pipeline We're looking for an empathetic salesperson who is a good listener and can adapt well to change and has a strong work ethic Proficient in using Linkedin, Hubspot, Aircall, Pandadocs A self-starter with a track record of successful, credible achievements Benefits Hubstaff is a fast-growing time-tracking and project management startup that fully embraces remote work. This is an employment position and a non-exempt role.
Sr. Software Developer - Hybrid
Company: Federal Home Loan Bank of Indianapolis
Location: Indianapolis, IN
Posted Sep 29, 2023
FHLBank Indianapolis is a cooperative bank dedicated to strengthening communities in Indiana and Michigan. They offer a flexible hybrid workforce model, competitive pay, tuition reimbursement, student loan repayment assistance, and an awesome benefits package. The company values diversity, equity, and inclusion, and promotes learning and development. They are seeking a Software Development Lead with expert object-oriented programming skills, extensive experience with MS.NET development environment, and knowledge of relational databases. The role involves leading a team of software developers, designing system architecture, and providing technical leadership.
Manager, Customer Success
Company: Genesys
Location: Indianapolis, IN
Posted Oct 17, 2023
We evaluate qualified applicants without regard to race, color, age, religion, sex, sexual orientation, gender identity or expression, marital status, domestic partner status, national origin, genetics, disability, military and veteran status, and other protected characteristics. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, disability, veteran status, and other protected characteristics. With Genesys, organizations have the power to deliver proactive, predictive, and hyper personalized experiences to deepen their customer connection across every marketing, sales, and service moment on any channel, while also improving employee productivity and engagement. Visit www.genesys.com. Actual salaries will vary depending on a candidate's experience, qualifications, skills, and location. Submissions entered for non-accommodation-related issues, such as following up on an application or submitting a resume, may not receive a response. About Genesys: Every year, Genesys orchestrates billions of remarkable customer experiences for organizations in more than 100 countries. Through the power of our cloud, digital and AI technologies, organizations can realize Experience as a Service™ our vision for empathetic customer experiences at scale. This is enabled by Genesys CloudTM, an all-in-one solution and the world's leading public cloud contact center platform, designed for rapid innovation, scalability, and flexibility. Through the power of the cloud and AI, our technology connects every customer moment across marketing, sales, and service on any channel, while also improving employee experiences.
Senior Quality Systems Specialist
Company: Genezen Laboratories
Location: Indianapolis, IN
Posted Oct 17, 2023
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. Aid in the development of Quality Management Systems (QMS), Quality Assurance (QA) people and teams.ESSENTIAL JOB FUNCTIONS / DUTIESSystem Administrator of Veeva Vault applicationsSubject matter expert and trainer on all Quality Management Systems, including but not limited to change control, quality events, investigation, and CAPAsResponsible for the development and maintenance of quality systems including a robust and continuous quality improvement system compliant with GMP and applicable to gene therapy products used in early phase clinical trialsResolves Veeva system problems and identifies areas for improvementInterface with Veeva managed services teamExtensive knowledge of document management systems (document lifecycles, workflows, user access & permissions)Extensive knowledge of Quality business processes, such as electronic document management systems, document lifecycles, change control, CAPA, Deviation business processes, and learning management systemsMaintain corporate policy and procedures for the Quality Management System in accordance with ICH Q10 modelCommunicate Veeva changes and deployments to Genezen sitesSupport customer audits and regulatory inspections as an SME for Quality Systems and Veeva applicationsResponsible for administration and user access of other Computer Systems on siteResponsible for QA metrics and key performance indicators, including Quality Management ReviewResponsible for Genezen Document Control and Training quality systemsResponsible for development and delivery of company training, such as Good Documentation Practices, annual GMP training, ad-hoc trainings, etc.Working with stakeholders, such as HR and dept heads, develop and maintain New Employee Orientation training.Participate as auditor in Internal Audit programManage the CAPA/Deviation and Change Control Review BoardsSPECIAL JOB REQUIREMENTSAdaptability required as work schedule may change based on business needsCriminal background check and drug screen requiredOther duties as assignedKNOWLEDGE, SKILLS & EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESEssential/DesiredBS in science or related fieldEssentialKnowledge of cGMP FDA and EU regulations, and ICH guidelinesEssentialFamiliar with regulatory guidelines for early phase clinical trialsEssentialON-THE-JOB EXPERIENCE Minimum of 5 years of working experience in a Pharmaceutical or Biologics industry in a QA roleEssentialPrevious Veeva experienceAdvanced skill level with Microsoft Office, especially Excel, Word, PowerPoint, and OutlookExcellent verbal and written communication and training skills, and patienceAbility to read, understand, and follow complex instructionsPeople-oriented -- enjoys interacting with people and working on group projectsEssentialEssentialEssentialEssentialEssentialPrevious experience in the field of Gene TherapyDesiredSKILLS / ABILITIES Manage multiple projects, set priorities, and work in fast-paced environmentEssentialExercises high level of independent decision making and ability to train and mentor othersCommunicate confidently and effectively with management, peers, and key stakeholdersEssentialEssentialDemonstrate effectiveness in task completion, decision-making, empowerment of others, training, and problem solvingEssentialPHYSICAL DEMANDSWhile performing the duties of this job, the employee is required to meet the following physical demands:Work EnvironmentOccasionally exposed to loud noise levelsPosition can be a combination of remote and on-siteRegularly sit for long periods of timeMovementFrequently 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 crawlLiftingFrequently lift and/or move up to 10 poundsOccasionally lift and/or move up to 25 poundsVisionFrequently utilize close vision and the ability to adjust focusCommunicationFrequently required to communicate by talking, hearing, using telephone and e-mailGENEZEN'S VALUE-BASED COMPETENCIESGrowth MindsetBelieve that skill is developed through dedication and hard work.Intelligence & talent are just the starting point.Mistakes are valuable lessons, not shameful indictments.FlexibilityAdapt rapidly to a quickly changing, CDMO environment.Respond by constructively creating & impacting opportunity through active participation.Team FocusWork together; succeed together; fail together.IntegrityDo the right thing, on time, every time.Speak up when needed.Exercise respect.Inclusion Embrace the unique viewpoint of each individual.Join the ongoing journey to a more inclusive workplace and community where we all help each other get better.GENEZEN'S BENEFITSPaid vacation days, amount based on tenurePaid sick time9 observed holidays + 1 floating holiday + 1 volunteer day401(k) plan with company match up to 6% of salary, vested immediatelyShare 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) InsuranceADDITIONAL DETAILSNothing 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 is located in Fishers, Indiana.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 is located in Fishers, Indiana, 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. Every employee contributes to the success of the company and you can be part of that team.PURPOSEBe an integral part of the quality assurance organization by providing administrator support and leadership for all Genezen quality systems and users. Address terms of systems quality and conformance to regulations and Genezen quality policies/procedures. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. Genezen is different. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. 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 GENEZENMany people have worked in environments where you feel like just another nameless part of an enormous machine. The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients.
Marketing Technology Architect, Lev
Company: Cognizant
Location: Indianapolis, IN
Posted Oct 17, 2023
. High-level , working knowledge of key digital marketing capabilities - customer identit y/context , data management , marketing analytics, marketing automation and orchestration , decision engines/offer engines/personalization, multi- channel activation , customer engagement . Excellent communication skills, written, verbal and interactive when online. Ability to guide product selection and/or marketing technology stack roadmaps for Salesforce Marketing Cloud, Braze, Airship, Iterable , etc. Design high quality business solutions for marketing automation platforms and/or tools (e.g., Salesforce Marketing Cloud, Braze, Airship, Iterable , etc.) Experience leading discoveries, gathering technical requirements, and executing a solution based on system best practices, platform limitations, and client ability to maintain. Ability to provide best practice guidance on data management and integrations (APIs, file-drops, etc.). Other key marketing capabilities - content management, enriching customer context on-demand and in real-time, data privacy. Preferred: Understanding of agile practices and associated tools (JIRA, Azure DevOps, or similar). PL3 The associate has comprehensive, in-depth and specialized knowledge of the skill.
Sr. Application Scientist, Liquid Handling
Company: Beckman Coulter Life Sciences
Location: Indianapolis, IN
Posted Oct 16, 2023
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. If you've ever wondered what's within you, there's no better time to find out. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. Given the essential job duties of this position, the employee is required to be fully vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation and applicable law. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Senior IT Business Analyst
Company: Allegion
Location: Indianapolis, IN
Posted Oct 10, 2023
Whatever your background, experience, race, color, national origin, religion, age, gender, gender identity, disability status, sexual orientation, protected veteran status, or any other characteristic protected by law, we will make sure that you have every opportunity to impress us in your application and the opportunity to give your best at work, not because we're required to, but because it's the right thing to do. © Allegion plc, 2020 | Block D, Iveagh Court, Harcourt Road, Dublin 2, Co. Dublin, Ireland REGISTERED IN IRELAND WITH LIMITED LIABILITY REGISTERED NUMBER 527370 Allegion is an equal opportunity and affirmative action employer Privacy Policy At Allegion, we are dedicated to building a diverse, inclusive, and authentic workplace. Together, we embrace all differences and similarities among colleagues, as well as the differences and similarities within the relationships that we foster with customers, suppliers and the communities where we live and work. So, if you're excited about this role but your past experience doesn't align perfectly with every item in the job description, we encourage you to apply anyway. As our values state, "this is your business, run with it". If for any reason you cannot apply through our career site and require an accommodation or assistance, please contact our Talent Acquisition Team. As we grow, we want you to grow with us. Allegion is committed to building and maintaining a diverse and inclusive workplace. Promote partnerships, collaboration, and communication across different functional and business teams for the delivery of solution Responsibilities: Analyze Business Requirements: Collaborate with stakeholders, including field service managers, technicians, and customers, to understand business processes and requirements related to field service operations.
Downstream Process Development - Subject Matter Expert
Company: Genezen Laboratories
Location: Indianapolis, IN
Posted Oct 04, 2023
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. The individual will provide technical expertise and leadership in science & technology and requires close collaboration with internal stakeholders.ESSENTIAL JOB FUNCTIONSBe accountable for establishing the downstream platform from small scale through intermediate scale (50L) lentiviral and retroviral vector processes.Responsible for monitoring and reporting on process performance, identifying opportunities, and implementing changes to improve process, product safety, and product quality.Develop and support process optimization efforts to increase process robustness, reduce costs, and improve viral yield and purity.Design and execute experiments independently: accurately record, analyze, and communicate data to senior management and team members.Maintain open communication via one-on-one and team meetings.Stay current with relevant technologies and needs to be adept at identifying new approaches.Perform and lead single-use system design manifold, selection, implementation, configurations in between Upstream bioreactor and downstream unit operations and control strategies.Develop SOP and batch records for downstream processesResponsible for the process transfer from or to clients and to in-house manufacturing plant.Maintain external technical relationships and collaborate with equipment and material suppliers.Serve as process SME for regulatory and client audits.Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the assigned functional area.SPECIAL JOB REQUIREMENTSAdaptability required as work schedule may change based on business needsCriminal background check requiredOther duties as assignedKNOWLEDGE, SKILLS AND EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESEssential/DesiredBS, MS, or PhD in biological engineeringDesiredON-THE-JOB EXPERIENCE 5-8 years of relevant industry experienceDesiredSolid foundation in the fundamentals of biochemical engineering, virology and cell biologyEssentialEntrepreneurial experience dealing with customers in product developmentDesiredPharmaceutical industry experience in technical support of cGMP manufacturing and/or process development, including experience with Contract Development and Manufacturing OrganizationsDesiredExperience with cell culture technologies, molecular biology, upstream processing, and aseptic processingDesiredSKILLS / ABILITIES Solid knowledge of principles of chromatography with AKTA system and Unicorn software and TFFSolid knowledge of principles of aseptic techniqueWorking knowledge of cGMPs related to the production of viral therapeuticsDesiredAbility to interface successfully with multi-disciplined teamsDesiredExtremely detail-oriented with strong technical skills & mechanically inclined/knowledge of hand toolsDesiredPHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands:Work EnvironmentFrequently 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 (maintenance, construction, commissioning and qualification) is requiredMovement Frequently 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 crawlLiftingFrequently lift and/or move up to 10 poundsOccasionally lift and/or move up to 25 poundsVisionFrequently utilize close vision and the ability to adjust focusCommunicationFrequently required to communicate by talking, hearing, using telephone and e-mailGENEZEN'S VALUE-BASED COMPETENCIESGrowth MindsetBelieve that skill is developed through dedication and hard work.Intelligence & talent are just the starting point.Mistakes are valuable lessons, not shameful indictments.FlexibilityAdapt rapidly to a quickly changing, CDMO environment.Respond by constructively creating & impacting opportunity through active participation.Team FocusWork together; succeed together; fail together.IntegrityDo the right thing, on time, every time.Speak up when needed.Exercise respect.Inclusion Embrace the unique viewpoint of each individual.Join the ongoing journey to a more inclusive workplace and community where we all help each other get better.GENEZEN'S BENEFITSPaid vacation days, amount based on tenurePaid sick time9 observed holidays + 1 floating holiday + 1 volunteer day401(k) plan with company match up to 6% of salary, vested immediatelyShare 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) InsuranceADDITIONAL DETAILSNothing 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 is located in Fishers, Indiana.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 is located in Fishers, Indiana, 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. Every employee contributes to the success of the company and you can be part of that team.JOB SUMMARYDirect the development and establishment of processes in Process Development. This individual is accountable for developing a scalable platform for viral vector production processes that minimizes the risk during Process Development to GMP scale-up. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Genezen is different. 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 GENEZENMany people have worked in environments where you feel like just another nameless part of an enormous machine. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients.
Quality Assurance Director
Company: Genezen Laboratories
Location: Indianapolis, IN
Posted Oct 04, 2023
Responsible for raw material inspection and release, Quality on the floor, disposition of drug product/drug substance, QA review of quality control data, root cause analysis, risk management, technical writing, deviation, change and CAPA management, document/records management, quality metrics reporting, data integrity, training management, QA review of method qualification/validation, process qualification/validation, and equipment/utilities/ facilities qualification and continuous improvement. Responsible for ensuring internal audits, client audits, supplier quality management, managing regulatory inspections, and quality systems are implemented effectively, efficiently, and compliantly at the site. Help build scalable, phase appropriate Quality systems as the organization continues to grow.ESSENTIAL JOB FUNCTIONS / DUTIESAct as a leader in the Quality organization, helping define and drive the Quality vision, mindset, and culture of the entire company in close collaboration with the Vice President of QA and RegulatoryDevelop overall program, implementation, and continuous improvement of the Quality Systems, which encompass but not limited to: QMS (Deviation, Change Control, CAPA), Documentation, Training, Supplier Management, Internal/Customer Audits and Customer Complaints.Ensure that Quality Systems are designed and operating in a way to provide appropriate support in all GxP areas of the company and are in compliance with current ISO and GMP standards (cGMP) both US FDA and EU applicable to gene therapy as appropriate for early phase clinical trialsDevelop, implement, and maintain corporate policy and procedures for the Quality Management System in accordance with ICH Q10 modelTake lead role in evaluating continuous improvement options for the Quality Systems post initial implementationResponsible for supporting all client projects as the quality lead and attending all meeting for current and prospective clients.Develop user requirements and contribute to the configuration, validation, implementation, and lifecycle management of the electronic Quality Management System (eQMS - Veeva)Develop, implement, and oversee a Quality Supplier Management Program that serves all GxP areas including introduction and qualification of suppliers and materials, supplier material changes, supplier complaintsEnsure that all products manufactured at the site are produced, tested, and released in compliance with SOPs, cGMP’s, US FDA, and EU requirements.Establish and continuously improve the Incoming Quality Assurance (IQA), Quality Oversight, and Batch Release programsResponsible for all raw material and final product release from the facilityEstablish department / individual goals and key performance indicators in alignment with company and operational goalsMaintain and report applicable department and delivery metricsEstablish the Quality Management Review Program, including facilitating creation of the presentation materials to include the Key Performance indicators, the meeting agenda, and attendance, and to orchestrate the material presentationManage internal quality improvement initiatives: evaluate internal processes, suggest/design/implement improvements, create/revise relevant SOPs/PoliciesAct as subject matter expert and provide training on all Quality Management Systems, including but not limited to change control, quality events, investigation, and implementation of effective CAPAsOwn and oversee the compilation of the Site Master File (SMF)Coach, train, and develop the Quality teamDevelop budget for department and ensure adherence to the budgetDrive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountabilityStay current with regulatory guidance as it applies to the Gene Therapy and early phase clinical trialsAct as a member of the site leadership team and engage in business decision-making from a Quality perspectiveEnsure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the QA departmentSPECIAL JOB REQUIREMENTSAdaptability required as work schedule may change based on business needsCriminal background check and drug screen requiredOther duties as assignedKNOWLEDGE, SKILLS & EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESEssential/DesiredBS degree in science or related fieldEssentialIn depth Knowledge in industries regulated in-part by, 21 CFR Part 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 21 CFR 610, Eudralex Volume 4, ICH Quality Guidelines, and Guidance to Industry dockets, as applicable for early phase clinical trialsEssentialCertified AuditorDesiredON-THE-JOB EXPERIENCE 10+ years of experience Quality Professional in Pharmaceutical and/ or Biological ManufacturingEssential7+ years of experience Quality SystemsEssential5+ years of experience Quality ManagementEssentialExperience conducting Supplier Audits, including for APIDesiredExperience with Phase I/II IND clinical trialsDesiredSKILLS / ABILITIES Manage multiple projects, set priorities, and work in fast-paced environmentEssentialCommunicate confidently and effectively with management, peers, and key stakeholdersEssentialDemonstrate effectiveness in task completion, decision-making, empowerment of others, deviation/nonconformance management, training, and problem solvingEssentialDemonstrated ability to develop quality systems and a quality management planEssentialPHYSICAL DEMANDSWhile performing the duties of this job, the employee is required to meet the following physical demands:Work EnvironmentOccasionally exposed to loud noise levelsPosition can be combination of remote and on-siteRegularly sit for long periods of timeMovementFrequently 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 crawlLiftingFrequently lift and/or move up to 10 poundsOccasionally lift and/or move up to 25 poundsVisionFrequently utilize close vision and the ability to adjust focusCommunicationFrequently required to communicate by talking, hearing, using telephone and e-mailGENEZEN'S VALUE-BASED COMPETENCIESGrowth MindsetBelieve that skill is developed through dedication and hard work.Intelligence & talent are just the starting point.Mistakes are valuable lessons, not shameful indictments.FlexibilityAdapt rapidly to a quickly changing, CDMO environment.Respond by constructively creating & impacting opportunity through active participation.Team FocusWork together; succeed together; fail together.IntegrityDo the right thing, on time, every time.Speak up when needed.Exercise respect.Inclusion Embrace the unique viewpoint of each individual.Join the ongoing journey to a more inclusive workplace and community where we all help each other get better.GENEZEN'S BENEFITSPaid vacation days, amount based on tenurePaid sick time9 observed holidays + 1 floating holiday + 1 volunteer day401(k) plan with company match up to 6% of salary, vested immediatelyShare 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) InsuranceADDITIONAL DETAILSNothing 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 is located in Fishers, Indiana.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 is located in Fishers, Indiana, a suburb of Indianapolis. 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. Fishers was named the 1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Every employee contributes to the success of the company and you can be part of that team.PURPOSELeads the Quality Assurance team, including Quality Systems and Quality Operations. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. 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 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 GENEZENMany people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work.