Manufacturing Team Lead- Formulation, 2nd shift

The Technical Support and Manufacturing Science Specialist will be responsible for supporting all facets of Tech Transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing (cGMP) for clinical and commercial programs.
This role will provide strong technical oversight to the business to ensure robust and reliable production processes are executed as specified, as well as support TS/MS Technical Transfer owners in completion of key activities.

Job responsibilities:

• TS/MS Engineer (Manufacturing Specialist) is responsible for directly supporting operations in the manufacturing of drug product in a way that is in accordance with current good manufacturing practices (cGMP).
• Represent TS/MS on the manufacturing floor to support answering questions and making decisions in alignment with cGMPs and technical transfer requirements.
• Participate in project teams and communicates directly with internal stakeholders and on occassion customers. Recognized as Subject Matter Expert for the manufacturing processes
• Author GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms.
• Monitor Process Data, identify trends and propose actions as necessary.
• Leads technical troubleshooting and investigations of process issues to support root cause analysis, product impact assessment and effective corrective and preventive actions.
• Provide technical guidance and oversight to Operations and Validation group to support Process Performance Qualification and Continuous Process Verification as specified by the TS/MS Technical Transfer owner.
• Collaborate with cross-functional team to provide feedback to assist with assessment and implementation of new technology for GMP manufacturing.
• Able to assess impact of changes to the product, process, equipment, procedures and/or materials
• Other responsibilities as required

• Bachelors’ degree in Science or Engineering OR a minimum of 5 years of GMP experience directly in the formulation and aseptic filling drug products.
• For non-degree holders, experience must be directly in the formulation and aseptic filling of drug products in a cGMP environment.
• Must be able to translate technical information colloquially.

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.