Process Specialist

· Knowledge of process control, quality engineering, sampling requirements, statistical techniques, and process capability.

· Familiarity with relevant quality and regulatory requirements and trends and cGMP's.

· Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders, and technical leaders.

· 4 years minimum experience working in a GMP environment.

· Batch record and associated manufacturing report review experience.

· Deviation and technical writing experience.

· Client and Regulatory Agency audit experience.

· Excellent written and verbal communication skills.

· General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).

· 1-2 years demonstrated working knowledge of aseptic manufacturing operations.

· 1-2 years in a people leadership role.

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.

By submitting your resume and details, you are declaring that the information is correct and accurate.