Jobs · Manufacturing · Indiana

Manager, Technical Operations

Prince Edward Island BioAlliance · Indiana, United States · 2 days ago
ManufacturingFull-time

About the role

The Manager, Technical Operations will lead technical operations activities to support the manufacturing process and ensure compliance with all regulatory requirements.

Responsibilities

  • Oversee the technical operations team to ensure efficient and effective execution of processes
  • Develop and maintain technical documentation and procedures
  • Ensure compliance with cGMP and other relevant regulations
  • Collaborate with cross-functional teams to resolve technical issues and improve operational efficiency
  • Lead continuous improvement initiatives to enhance process performance and reduce costs

Requirements

  • Bachelor's degree in a relevant field such as Chemical Engineering, Biotechnology, or related discipline
  • Minimum 5 years of experience in technical operations or manufacturing in the pharmaceutical industry
  • Experience with cGMP regulations and Good Manufacturing Practices (GMP)
  • Strong leadership skills and ability to manage a team
  • Excellent communication and problem-solving skills

Qualifications

  • Knowledge of microbial fermentation, synthetic small molecules, ADC, HPAPI, plasmid DNA, mRNA, and sterile filling processes
  • Experience with process development and scale-up
  • Ability to work independently and as part of a team

Skills

  • Technical expertise in pharmaceutical manufacturing
  • Leadership and management skills
  • Problem-solving and decision-making abilities
  • Strong organizational and time management skills

Benefits

  • Competitive compensation package
  • Flexible working hours
  • Professional development opportunities
  • Health and wellness programs

Pay

Commensurate with experience

Schedule

Full-time

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