
Genezen · Indianapolis, IN
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 ve...
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.
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.
Be an integral part of the quality assurance and quality systems team by providing quality oversight and expertise to operations,
manufacturing, and quality control activities. Address terms of product quality and conformance to regulations and Genezen quality
policies/procedures. Help in the development of QA people and teams.
presence. Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and
regulatory requirements
improvements.
and procedures.
established specifications.
gathering data from various sources across the site (ex. Quality oversight, trend data, and training records), as well as
performing interviews of personnel related to the Quality Events.
products,
from Operational areas
manufactured according to approved procedures and complies with applicable regulations
Essential/Desired
Bachelor’s degree in science or related field
Essential
Experience 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 trials
Essential
Familiarity of eQMS systems such as Veeva
Desired
Knowledge of cGxPs, clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms
Desired
3-5 years of working experience in a Pharmaceutical or Biologics industry in a Quality Assurance role
Essential
Experience working in with early phase clinical trial production and testing
Desired
Previous experience with a startup CDMO and/or in the field of Gene Therapy
Desired
Manage multiple projects, set priorities, and work in fast-paced environment
Essential
Communicate confidently and effectively with management, peers and key stakeholders
Essential
Demonstrate effectiveness in task completion, decision-making, empowerment of others, deviation/nonconformance management,
training, and problem solving
Essential
Work independently and be self-motivated
Essential
Proven ability to work cross-functionally to achieve business outcomes
Essential
While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment
Movement
Vision
Communication
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.
this job at any time.
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.
Description Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: * We empower and support our colleagues * We commit to client success at every turn * We have the courage to do the right thing * We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. * We constantly acquire new skills and learn from our experiences to enhance our collective expertise Documentation Specialist Responsibilities: * Strong editing and technical writing skills * Strong attention to detail * Strong ability to communicate effectively * Must work well with cross-functional team members, including, Engineering, Quality, TS/MS * Ability to receive direction and make applicable changes * Excellent organizational and time management skills * Intermediate skills with Microsoft Word * Ability to work in fast-paced environment Minimum Qualifications: * Minimum Education: Associate or Bachelor’s degree * Exceptional attention to detail and organizational skills * Clear and professional communication skills * Experience with document management and tracking systems * Capable of multitasking and prioritizing independently * Comfortable in fast-paced environments with frequent changes * Onsite job requirement in Indianapolis, IN Preferred Qualifications: * Experience with SOP redlines * Previous experience with CMS system, such as Veeva * Experience with Good Documentation Practice * Exposure to TrackWise * Working knowledge of Microsoft Teams and other collaborative tools * Understanding of database structures and document control workflows For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future. *Verista is an equal opportunity employer. National (US) Range $59,951—$69,929 USD Benefits Why Choose Verista? * High growth potential and fast-paced organization with a people-focused culture * Competitive pay plus performance-based incentive programs * Company-paid Life, Short-Term, and Long-Term Disability Insurance. * Medical, Dental & Vision insurances * FSA, DCARE, Commuter Benefits * Supplemental Life, Hospital, Critical Illness and Legal Insurance * Health Savings Account * 401(k) Retirement Plan (Employer Matching benefit) * Paid Time Off (Rollover Option) and Holidays * As Needed Sick Time * Tuition Reimbursement * Team Social Activities (We have fun!) * Employee Recognition * Employee Referral Program * Paid Parental Leave and Bereavement Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice [https://apply.workable.com/verista/ccpa_policy?lng=en] for further details. For more information about our company, please visit us at Verista.com [https://apply.workable.com/verista/]
How You’ll Make An Impact At Strive Health, patients come first. We’re on a mission to transform chronic conditions by identifying risk earlier, coordinating thoughtful care, and supporting people through every stage of their health journey. Our work reduces emergency visits, improves outcomes, and helps patients live fuller lives. You’ll work alongside passionate Strivers who care deeply about making an impact, show up for one another as One Team, and find ways to elevate the everyday. If you’re looking for meaningful work where your contributions truly matter, you’ll feel right at home at Strive! Benefits & Perks * Hybrid-Remote Flexibility – Work from home while fulfilling in-person needs at the office, clinic, or patient home visits. * Comprehensive Benefits – Medical, dental, and vision insurance, employee assistance programs, employer-paid and voluntary life and disability insurance, plus health and flexible spending accounts. * Financial & Retirement Support – Competitive compensation with a performance-based bonus program, 401k with employer match, and financial wellness resources. * Time Off & Leave – Paid holidays, vacation time, sick time, and paid birthgiving, bonding, sabbatical, and living donor leaves. * Wellness & Growth – Family forming services through Maven Maternity at no cost and physical wellness perks, mental health support, and an annual professional development stipend. To learn more about our offerings, click here [https://strivehealth.com/careers/]. How You’ll Make An Impact As a Clinical Lead within our interdisciplinary team, you do more than treat a diagnosis—you are the visionary architect of a better life for patients navigating the complexities of CHF, CKD/ESKD, and other chronic conditions. At Strive, we have shattered the constraints of the 15-minute office visit. Here, you are granted the true autonomy to provide longitudinal, deeply personal care that meets patients exactly where they are: in their homes and via telehealth. In this role, you will harness the power of advanced analytics, cutting-edge technology platforms, and seamless interdisciplinary collaboration to ensure world-class care reaches the right patient at the precise moment they need it. As the trusted navigator for a dedicated panel, you will blend high-touch clinical expertise with a radical "whole-person" approach. Your mission is to move the needle on what truly matters: * Keeping patients out of the hospital. * Slowing disease progression, ensuring every individual feels seen, heard, and deeply cared for. Strive is fiercely committed to advancing technology that makes the Nurse Practitioner role as efficient as it is impactful. We are obsessed with reducing administrative burden, clearing the path so you can reclaim your time for what you do best: meaningful clinical care and transformative patient engagement. The Day to Day * Manages a defined patient panel with accountability for quality, cost and outcomes. Collaborates with external providers and care teams to ensure goals, treatment, and care plan alignment. * Obtains patient history, performs physical exam, orders and interprets diagnostic tests and formulates a plan for individual patient short-term and longitudinal needs. * Ensures assessment and plan of care incorporate best practices for chronic kidney care including management of all stages of CKD, ESKD and heart failure. Will support transitions to renal replacement therapy, transplant, or conservative care) as well as participation in shared decision-making and end-of-life/advanced care planning discussions. * Accurately documents and captures diagnoses to support risk adjustment (HCC coding), identify and address care gaps related to HEDIS and preventative care. * Presents patient cases and provides clinical support for clinical rounds and interdisciplinary team meetings. * Serves patients and performs patient visits in multiple care settings a including patient home, telehealth visits or dialysis clinics/partner MD space (where applicable). * Responsible for maintaining current board certification and state-specific continuing education requirements. * Adheres to expectations outlined in Strive’s documentation policy * Provides in-person patient care which may include standing, sitting, walking, pushing, pulling, and lifting. Minimum Qualifications * Master’s degree in Nursing or similar field. * 2+ years experience as a Family Nurse Practitioner (NP), Primary Care Nurse Practitioner (NP) or equivalent with specialization in cardiology (CHF) or Nephrology (CKD) * 2+ years experience with Electronic Health Records (EHR) * Current state specific licensure. * National Board Certification. * Current Drug Enforcement Administration (DEA) license or eligible to obtain within 90 days of hire. * Current BLS or CPR Certification. * Efficient and reliable transportation, including an active driver’s license, allowing for the ability to travel across an assigned region to meet patient needs. Locations may include offices, clinics, and patient homes. * Basic computer and Microsoft Office skills * Internet Connectivity - Min Speeds: 3.8Mbps/3.0Mbps (up/down): Latency <60 ms. Preferred Qualifications * Demonstrated expertise in CKD management (Stages 3–5), ESRD care, and dialysis management (hemodialysis and/or peritoneal dialysis, HHD), including medication optimization, volume assessment, and complication management * Experience leading care transitions across settings (hospital → outpatient → dialysis) with a focus on reducing readmissions and ensuring continuity of care * Proven ability to deliver comprehensive patient education on kidney disease progression, dialysis modality selection (home vs. in-center), and kidney transplant pathways to support informed, shared decision-making * 2+ years experience with Electronic Health Records (EHR). * Wound Care certification * Experience using audio-visual technology platforms About You * Demonstrated proficiency in clinical assessment, diagnosis, planning, implementation, documentation, and evaluation of complex chronic patients. * Excellent communicator, team builder, and evidence of results. * Demonstrated knowledge and understanding of data and managing clinical, financial, and patient satisfaction outcomes. * Excels at developing and fostering strong patient and family relationships that center on engagement, trust, honesty, empathy, follow-through and doing what’s best for the patient. Annual Salary Range: $112,000.00-$140,000.00. **This role is eligible for a geographic differential of 8% if located within 50 miles of the Chicago Metro area. This position is also eligible for a target annual bonus of 10% Final compensation will be determined based on location, experience, and qualifications. Strive Health is an equal opportunity employer and drug free workplace. At this time Strive Health is unable to provide work visa sponsorship. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Please apply even if you feel you do not meet all qualifications. If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to talentacquisition@strivehealth.com. [talentacquisition@strivehealth.com] We do not accept unsolicited resumes from outside recruiters/placement agencies. Strive Health will not pay fees associated with resumes presented through unsolicited means.
Description Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: * We empower and support our colleagues * We commit to client success at every turn * We have the courage to do the right thing * We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. * We constantly acquire new skills and learn from our experiences to enhance our collective expertise SENIOR PROJECT ENGINEER RESPONSIBILITIES: OXYGEN DEPLETION PROGRAM SUPPORT * Lead engineering activities supporting laboratory oxygen (O₂) depletion risk management across research facilities. * Evaluate laboratories utilizing oxygen-depleting gases and cryogenic liquids to ensure compliance with internal HSE standards and industry best practices. * Develop and maintain standardized engineering approaches for oxygen depletion assessments. ENGINEERING ASSESSMENTS & RISK ANALYSIS * Perform oxygen and carbon dioxide (CO₂) depletion calculations for laboratories utilizing: * Nitrogen (N₂) * Argon (Ar) * Carbon Dioxide (CO₂) * Helium (He) * Other oxygen-displacing gases as required * Conduct laboratory data collection necessary to complete engineering risk assessments. * Evaluate laboratory ventilation systems in partnership with Building Engineers. * Assess laboratory airflows and ventilation effectiveness supporting safe operation. OXYGEN DEPLETION RISK ASSESSMENTS * Author comprehensive Oxygen Depletion Hazard (ODH) Risk Assessments for laboratories utilizing: * Compressed gases * Cryogenic liquids * Oxygen-depleting chemicals * Prepare specialized ODH assessments for Nuclear Magnetic Resonance (NMR) laboratories utilizing liquid helium systems. * Recommend engineering controls and mitigation strategies based on assessment findings. SENSOR EVALUATION & IMPLEMENTATION * Determine laboratory requirements for: * Oxygen sensors * Carbon dioxide sensors * Associated HSE safety signage * Coordinate installation activities with Facilities and Building Engineering teams. * Verify appropriate sensor placement and implementation. PROGRAM DOCUMENTATION & DATA MANAGEMENT * Maintain an inventory of laboratories utilizing: * Nuclear Magnetic Resonance (NMR) equipment * Oxygen-depleting gases * Cryogenic liquids * Update engineering databases, tracking spreadsheets, and documentation supporting the Oxygen Depletion Program. * Ensure documentation remains accurate, current, and audit-ready. PROCESS IMPROVEMENT & AUTOMATION * Support initiatives to automate the laboratory oxygen assessment process. * Evaluate software tools and engineering methodologies capable of generating automated oxygen depletion reports. * Assist in developing standardized calculation methodologies and digital workflows. * Collaborate on SmartForm development and data automation initiatives. CROSS-FUNCTIONAL COLLABORATION * Partner with: * Environmental Health & Safety (HSE) * Facilities Engineering * Building Engineers * Research Scientists * Laboratory Operations * Provide technical guidance regarding oxygen depletion hazards and engineering controls. * Support project planning, implementation, and continuous improvement efforts. REQUIREMENTS: * Bachelor's degree in Engineering (Mechanical, Chemical, Environmental, Biomedical, Industrial, or related discipline). * 7+ years of engineering experience supporting laboratory, research, pharmaceutical, biotech, chemical, or manufacturing environments. * Experience performing engineering calculations and technical risk assessments. * Strong understanding of laboratory safety principles. * Experience working with building mechanical systems and ventilation concepts. * Excellent technical writing skills with experience authoring engineering reports or risk assessments. * Strong analytical, organizational, and problem-solving abilities. * Proficiency with Microsoft Excel and Microsoft Office Suite. PREFERRED QUALIFICATIONS: * Experience supporting pharmaceutical or biotechnology research facilities. * Knowledge of Oxygen Deficiency Hazard (ODH) assessments. * Experience with compressed gases, cryogenic liquids, or laboratory safety programs. * Familiarity with Nuclear Magnetic Resonance (NMR) laboratory operations. * Experience working with Environmental Health & Safety (HSE) programs. * Experience evaluating HVAC airflow or laboratory ventilation systems. * Knowledge of applicable OSHA, NFPA, ASHRAE, or other laboratory safety standards. * Experience implementing engineering controls within laboratory environments. PREFERRED TECHNICAL SKILLS: * Experience automating engineering calculations and reporting workflows. * Familiarity with data analysis and process automation tools. * Experience developing SmartForms, digital workflows, or automated engineering documentation. * AI experience is highly preferred, including the use of AI-assisted tools to: * Automate oxygen depletion calculations * Generate engineering reports * Develop SmartForms * Improve engineering data management and workflow efficiency For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future. *Verista is an equal opportunity employer. National (US) Range $85,000—$126,235 USD Benefits Why Choose Verista? * High growth potential and fast-paced organization with a people-focused culture * Competitive pay plus performance-based incentive programs * Company-paid Life, Short-Term, and Long-Term Disability Insurance. * Medical, Dental & Vision insurances * FSA, DCARE, Commuter Benefits * Supplemental Life, Hospital, Critical Illness and Legal Insurance * Health Savings Account * 401(k) Retirement Plan (Employer Matching benefit) * Paid Time Off (Rollover Option) and Holidays * As Needed Sick Time * Tuition Reimbursement * Team Social Activities (We have fun!) * Employee Recognition * Employee Referral Program * Paid Parental Leave and Bereavement Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice [https://apply.workable.com/verista/ccpa_policy?lng=en] for further details. For more information about our company, please visit us at Verista.com [https://apply.workable.com/verista/]