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Director Cdmo Jobs in Indiana (NOW HIRING)

INCOG

Senior Validation Engineer

Fishers, IN

They will possess a demonstrated ability to influence positive outcome without direct reporting ... At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture ...

INCOG

Manager of Packaging

Fishers, IN

Conduct regular performance management and coaching conversations with direct reports, establishing ... Experience at a CDMO with multi-client product portfolio management. * Familiarity with device ...

INCOG BioPharma Services

Manager of Packaging

Fishers, IN · On-site

$90 - $120/hr

... sterile injectable CDMO. Essential Job Functions Strategic Leadership & Program Management ... Conduct regular performance management and coaching conversations with direct reports, establishing ...

INCOG

QA Batch Review Specialist

Fishers, IN

... direct reporting authority. Essential Job Functions: Full lifecycle review and disposition of ... At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture ...

INCOG

Senior QA Batch Disposition Specialist

Fishers, IN

$77K - $106K/yr

... without direct reporting authority. Essential Job Functions: * Lead full lifecycle review and ... Experience with client-facing batch release coordination in a CDMO environment, including ...

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Director Cdmo information

What is the difference between Director Cdmo vs Director Regulatory Affairs?

AspectDirector CdmoDirector Regulatory Affairs
Required CredentialsAdvanced degree in life sciences, engineering, or related field; industry experienceAdvanced degree in life sciences, law, or related field; regulatory certifications often preferred
Work EnvironmentContract manufacturing organizations, pharmaceutical or biotech companiesPharmaceutical companies, biotech firms, regulatory agencies
Employer & Industry UsageUsed in contract manufacturing and development settingsUsed in companies overseeing product approval and compliance

The main difference is that a Director Cdmo focuses on managing contract manufacturing and development projects, while a Director Regulatory Affairs handles regulatory compliance and approval processes. Both roles require advanced degrees and industry experience but serve different functions within the pharmaceutical and biotech sectors.

What are the most commonly searched types of Cdmo jobs in Indiana?

The most popular types of Cdmo jobs in Indiana are:

What are popular job titles related to Director Cdmo jobs in Indiana?

For Director Cdmo jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Director Cdmo jobs in Indiana look for?

The top searched job categories for Director Cdmo jobs in Indiana are:

Director Cdmo jobs near you

Senior Validation Engineer

INCOG BioPharma Services

Fishers, IN • On-site

Full-time

Re-posted 16 days ago

Job description

Description
INCOG BioPharma is seeking a highly motivated Senior Validation Engineer with validation expertise to join our team. The Senior Validation Engineer is a key individual contributor role within the INCOG BioPharma Validation Department. The Senior Validation Engineer is responsible for understanding and implementing validation requirements for a sterile injectables manufacturing facility. The ideal candidate has subject matter expertise and practical experience in qualification and validation.
The Senior Validation Engineer will partner with internal customers to meet the needs of client projects, facility upgrades, capital expansion projects, and laboratory systems. They will possess a demonstrated ability to influence positive outcome without direct reporting authority. Additionally, they must thoroughly understand and be able to adapt to the changing needs of a manufacturing environment.
Essential Job Functions:
  • Perform Qualification activities on utilities, equipment and laboratory systems. This includes, but is not limited to, clean utilities, autoclave, washer, filler, laboratory instruments, controlled temperature units, etc.
  • Interact with clients to provide validation support including but not limited to, customer product launches, new equipment qualifications.
  • Support and provide validation oversight for capital expansion projects/build outs
  • Take ownership in the development and modification of Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines for equipment validation policies, standards, procedures, and templates
  • Review facility changes and provide input on re-validation and re-qualification of equipment
  • Assess risks involved in processing steps related to equipment, developing and/or reviewing validation requirements and design deliverables
  • Engage in a cross functional team and work closely with other supporting groups including Engineering and Operations to support and monitor validation and process improvement efforts
  • Conduct validation qualifications in accordance with all applicable protocols and identify associated protocol excursions.
  • Identify industry trends in validation and expectations of regulatory agencies and propose program modifications as appropriate to align with current requirements.

Special Job Requirements:
  • Bachelor's degree or higher in STEM discipline
  • 5-8 years of experience in Validation or related discipline
  • 4+ years GMP experience required or other regulated industry
  • Physically capable of working onsite

Additional Preferences:
  • Master's degree or higher preferred
  • Computer System Validation experience preferred
  • Cleaning Validation experience preferred
  • VHP & Steam Sterilization experience preferred

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.

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