Manufacturing Manager

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 product; and continuously improve manufacturing processes.

ESSENTIAL JOB FUNCTIONS

• Provide leadership, coaching, and mentoring to the Manufacturing organization across multiple shifts
• Hire, coach, and develop Manufacturing team members, including performance management and periodic reviews
• Plan, direct, and oversee Vector Manufacturing activities including the scheduling of resources, material staging, equipment preparation, batch execution, cleaning/sanitization, inventory transactions, and batch record review
• Complete on-time delivery of product to clients, including review of Manufacturing records and investigations
• 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
• Represent the Manufacturing function during client and regulatory audits
• Work collaboratively with cross functional teams in engineering, process development, project management, etc. to facilitate a successful customer experience
• Manage the Manufacturing Production system including but not limited to personnel development, problem solving, investigation of issues, root cause analysis, CAPA, 5S, visual factory, etc.
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the Manufacturing department

SPECIAL WORK REQUIREMENTS

• Willingness to occasionally work nights and weekends required, with the ability to address unplanned facility situations as they arise
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

BS in Biology, Chemistry or Engineering

Desired

In-depth knowledge of aseptic processing

Essential

ON-THE-JOB EXPERIENCE

5 to 10 years of related work experience in a GMP environment

Essential

2 to 5 years of supervisory experience

Essential

Drug Substance experience with cell culture and upstream/downstream processing

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

PHYSICAL DEMANDS

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 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.
• While performing the duties of this job, the employee must be aware of potential exposure to moving mechanical parts; high, precarious places; toxic or caustic chemicals; high noise areas, and risk of electrical shock.
• A physically able individual is required who can spend time on the floor during activity execution (maintenance, construction, commissioning and qualification).

GENEZEN'S VALUE-BASED COMPETENCIES

Growth Mindset
Believe that skill is developed through dedication and hard work.
Intelligence & talent are just the starting point.
Mistakes are valuable lessons, not shameful indictments.

Flexibility
Adapt rapidly to a quickly changing, CDMO environment.
Respond by constructively creating & impacting opportunity through active participation.

Team Focus
Work together; succeed together; fail together.

Integrity
Do 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 BENEFITS

• Paid vacation days, amount based on tenure, and paid sick time
• 8 observed holidays + 1 floating holiday + 1 volunteer day
• 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

ADDITIONAL DETAILS

• 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 is an Equal Opportunity Employer.
• 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. 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 museumto name just a few reasons why this area is a great place to live.