Technical Services Supervisor

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INCOG Biopharma Services in Indianapolis, IN is hiring a Technical Services Supervisor, who 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 regulatory compliance.

The position delivers technical guidance and supervision throughout the production process, with the objective of establishing production processes that are robust, reliable and capable of consistently delivering high-quality products. This entails overseeing production stages, identifying opportunities for improvement, and implementing measures to enhance efficiency and effectiveness of operations.

At INCOG, the team focuses on creating meaningful experiences and a culture that enables everyone to thrive. INCOG is a world-class CDMO for parenteral injectable drugs, shaping a future for patients, for the team, and for clients.

• Lead a small team of Technical Services Engineers and Technical Writers with expertise in drug product formulation, single-use system mixing, filtration, filling, and visual inspection.
• Provide leadership and guidance in technical decision-making related to manufacturing operations.
• Lead 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 groups to support Process Performance Qualification and Continuous Process Verification.
• Lead efforts in production excellence to support commercial scalability and compliance.
• Author and review regulatory information packages and filings/submissions.
• Represent Tech Services in project teams and communicate directly with customers. Recognized as Subject Matter Expert for INCOG processes.

• 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.

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Note:

Don’t meet all the requirements? We’re open to discussing opportunities. Equality and diversity in employment are supported by Lead Candidate and INCOG.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Manufacturing, Project Management, and Quality Assurance

Industries

• Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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