Technical Services Supervisor
Description
The Tech Services Supervisor will be responsible for supporting all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification. This role oversees the optimization and continuous improvement of manufacturing processes and technologies to ensure product quality, efficiency and compliance with regulatory standards.
This position holds the responsibility of delivering substantial technical guidance and supervision throughout the production process. The primary objective is to establish production processes that are not only robust and reliable but also capable of consistently delivering high-quality products. This entails overseeing the various stages of production, identifying potential areas for improvement, and implementing measures to enhance the overall efficiency and effectiveness of the production operations.
Essential Job Functions:
- Lead a small team of Tech Services Engineers and Technical Writers with expertise in drug product formulation, single-use system mixing, filtration, filling, visual inspection etc.
- Provide leadership and guidance in technical decision-making related to manufacturing operations.
- Leads technical troubleshooting and investigations of manufacturing processes to support root cause analysis, product impact assessment and effective corrective and preventive actions.
- Implement process improvements based on data analysis and scientific principles.
- Provide technical guidance and oversight to Operations and Validation group to support Process Performance Qualification and Continuous Process Verification.
- Lead efforts in production excellence to support commercial scalability and compliance.
- Author and review of regulatory information packages and filings/submissions.
- Represents Tech Services in project teams and communicates directly with customers. Recognized as Subject Matter Expert for the INCOG processes.
- Collaborate with cross functional teams to trouble shoot and resolve technical issues.
- Other responsibilities as required.
Special Job Requirements:
- Bachelor’s degree in science, Engineering or related scientific discipline required.
- Master’s degree in science, Engineering or related scientific discipline strongly preferred.
- 3+ years GMP experience with manufacturing processes and equipment in related fields such as biologics, pharmaceutical fill and finish required.
- 1-3 years of experience in leadership or mentorship
- Experience in regulated GMP manufacturing operations required.
- Strong communication and problem-solving skills.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.