Packaging Team Lead, 2nd shift at INCOG BioPharma in Fishers, IN

INCOG BioPharma Services is seeking a subject matter expert (SME) with capabilities in the packaging of sterile drug products. The Packaging Lead is a key role within the organization. The ideal candidate must have experience in the packaging of pharmaceutical drug products.

The primary responsibility of the Packaging Lead is to perform continuous monitoring of the packaging process and provide in-process daily review of executed batch record and form entries, drive team activities for the packaging of sterile drug products and ensure compliance with quality systems, policies, procedures, and cGMP practices. They will be responsible for meeting/exceeding production standards, maintaining product quality, and minimizing/preventing equipment downtime. The ideal candidate will ensure compliance with quality systems, policies, procedures, and cGMP practices and collaborate effectively with internal partners, clients, and vendors.

Essential Job Functions:

• Assist Packaging Supervision, supporting a team of 6 to 10 associates daily, to package syringes, vials and device assemblies.
• Follow production and manufacturing procedures.
• Perform in-process checks to identify packaging defects and machinery issues.
• Escalate packaging issues to Supervision as required.
• Perform reconciliation of finished packaged product and defects.
• Provide input for process and document improvements.
• Operate equipment in compliance with SOPs.
• Assure compliance with cGMP requirements (current good manufacturing practices).
• Perform label and packaging activities for finished product.
• Complete and review associated production records, logbooks and forms.
• Assist other manufacturing functions as required.
• Train new employees to perform packaging activities.
• Collaborate and communicate with cross functional teams.
• Work flexible hours to ensure production facility coverage.

Special Job Requirements:

• High School diploma required, minimum 1 year of GMP pharmaceutical experience in drug product inspection and/or packaging.
• Awareness of regulatory requirements and industry guidance applicable to CGMPs for Combination Products, including 21 CFR Part 4 Regulation of Combination Products, FDA Guidance for Industry: Current Good Manufacturing Practice Requirements for Combination Products (2015), and ISO 13485:2016 Medical devices — Quality management systems.

Additional Preferences:

• Previous manufacturing leadership experience.
• Good math and documentation skills.
• Ability to perform repetitive tasks.
• Ability to learn and adapt to innovative ideas.
• Good observation skills.
• Initiative-taking and Collaborative.
• Effective organization skills and diligence.
• Ability to work with minimal supervision.

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.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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