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