Manufacturing Supervisor, Upstream

Manufacturing Supervisor, Upstream

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.

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.

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.

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 but not limited to 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

Prior leadership experience in 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 the documentation

Experience in (bio)-manufacturing unit operations

Good writing and oral communication skills

The work schedule may require adjustments to support production activities

Adaptability required as work schedule may change based on business needs

Criminal background check required

Other duties as assigned

BS in Biology, Microbiology, Chemistry, Virology, or any other relevant field of study
- Desired

In-depth knowledge of aseptic processing, GxP, cell culture, and bioreactor operation and troubleshooting
- Essential

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

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

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

Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms

Occasionally required to walk; climb or…