Job Description

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.

ESSENTIAL JOB FUNCTIONS

• 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

JOB QUALIFICATIONS

• 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

SPECIAL WORK REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned
  

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

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

ON-THE-JOB EXPERIENCE

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

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

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