The field of gene therapy is growing rapidly and Genezen Laboratories 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 LABORATORIES
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.
Genezen Laboratories is actively seeking a Downstream Process Development (DSP) Associate Director/Director to join a Lentiviral vector manufacturing CDMO located in Fishers, IN. This individual should display strong technical knowledge and scientific understanding of protein purification as well as having experience in process development at both small and large process scales. The person in this scientific role is expected to work collaboratively with the team to establish and implement best laboratory practices and lead the execution of complex experiments.
ESSENTIAL JOB FUNCTIONS
- Manage the DSP team, including hiring, training, career and goal development and assessment
- Lead and support downstream process development for purification and concentration of viral vectors or biologics
- Evaluate transferred downstream process for feasibility, quality and scalability
- Collaborate with analytical and upstream functional areas to determine appropriate method for viral vector/protein purification
- Use DoE and QbD approach for process design to guide decisions and/or assess impact to product or process
- Collaborate on technical transfer and scale-up as needed across departments
- Apply technical, functional and industry knowledge to design and evaluate upstream process, review and analyze data, and frame early and late phase needs
- Communicate with clients and internal quality and regulatory groups to transfer processes
- Communicate with internal teams for internal technology transfer process
- Maintain high quality deliverables and open communication, creating a collaborative working environment
- Execute research timelines to meet program and corporate objectives
- Serve as a subject matter expert for all areas of downstream processing
- Review technical documents for accuracy, thoroughness and regulatory compliance
- Participate in proposals to improve downstream process development approaches
- Provide monthly reports to department head
KNOWLEDGE, SKILLS AND EXPERIENCE
- BS in Engineering, Biotechnology, Biology or similar discipline + 10 years of industry experience
- OR A minimum of 5 years of experience with a MS OR 3 years of experience with a PhD
- Experience in downstream process development, deep knowledge of viral vectors or biologics downstream process development strategies and familiar with current industry best practices
- Demonstrated problem solving skills and written/verbal communication skills
- Ability to work independently within a team environment
- Demonstrated interpersonal skills to build relationships, act as change agent, and adapt to rapidly changing organizational and business needs
- Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential
- Familiar with chromatographic techniques for viral vector purification or biologics purification
- 3+ years of cGMP experience
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to work in a BSL 2/3 environment with personal protective equipment.
- While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
- In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.
GENEZEN'S VALUE-BASED COMPETENCIES
Believe that skill is developed through dedication and hard work.
Intelligence & talent are just the starting point.
Mistakes are valuable lessons, not shameful indictments.
Adapt rapidly to a quickly changing, CDMO environment.
Respond by constructively creating & impacting opportunity through active participation.
Work together; succeed together; fail together.
Do the right thing, on time, every time.
Speak up when needed.
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.
- Paid vacation days, amount based on tenure, and paid sick time
- 8 observed holidays + 1 floating holiday
- 401(k) plan with company match up to 6% of salary, vested immediately
- Choice of six healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- 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 is located in Fishers, Indiana.
- This position requires a criminal background check.
- Genezen Laboratories is an Equal Opportunity Employer.
- Genezen Laboratories is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
Genezen Laboratories 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. 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.