Manufacturing Supervisor, Upstream

About the role

Promote 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.

Responsibilities

• 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.
• 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 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 department.

Requirements

• Prior leadership experience in a GMP manufacturing facility.
• Preferably work experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization.
• Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes, and procedures.
• Hands-on experience in writing and reviewing documentation.
• Experience in (bio)-manufacturing unit operations.
• Good writing and oral communication skills.
• Adaptability required as work schedule may change based on business needs.
• 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.

Qualifications

• BS in Biology, Microbiology, Chemistry, Virology, or any other relevant field of study (desired).
• 4-6 years of related work experience in a GMP environment (essential).
• 1 year of supervisory experience (desired).
• Drug Substance experience with cell culture and upstream viral vector manufacturing (strongly desired).
• Experience using single-use systems (desired).
• In-depth knowledge of aseptic processing, GxP, cell culture, and bioreactor operation and troubleshooting (essential).

Skills

• Demonstrated interpersonal skills to build relationships, act as a change agent, manage conflict, and adapt to rapidly changing organizational and business needs.
• Ability to manage multiple priorities.

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning.
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities.
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock.
• Occasionally exposed to extremely loud noise levels.
• Spending time on the floor during activity execution (manufacturing, maintenance, construction, commissioning, and qualification) is required.

Movement: Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms. Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.

Lifting: Frequently lift and/or move up to 25 pounds. Occasionally lift and/or move up to 40-50 pounds.

Vision: Frequently utilize close vision and the ability to adjust focus. Corrected 20/20 vision to assist with visual inspection of Drug Products.

Communication: Frequently required to communicate by talking, hearing, using telephone and e-mail. Strong communication skills to efficiently collaborate and coordinate within manufacturing and cross-functional teams.

Company Values

• 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 principles.
• Solutions driven for our partners: We are committed to being a proactive, collaborative, creative, and open-minded partner.

Benefits

• Paid vacation days, amount based on tenure.
• Paid sick time.
• 10 observed holidays + 2 floating holidays + 1 volunteer day.
• 401(k) plan with company match up to 6% of salary.
• Share Appreciation Rights.
• Choice of several healthcare plans.
• FSA and HSA programs.
• Dental & vision care.
• Employer-paid basic term life/personal accident insurance.
• Voluntary disability, universal life/personal accident insurance.
• Accidental Death & Dismemberment (AD&D) Insurance.

About the Location

Genezen operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. This position is located in Fishers, 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.

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.