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Director Cdmo Jobs in Indiana (NOW HIRING)

Our leading CDMO client is eager to hire an Aseptic Downstream Process Development SME for their ... Direct the development and establishment of processes in GMP. Accountable for developing a scalable ...

CDMO experience preferred. Thanks & Regards, Vyshnavi Recruiter Intellectt Inc vyshnavi.t@intellectt.com Direct: 732 204 6550 Desk number: 732 412 6999 - Ext: 225

Senior QA Validation Specialist

Fishers, IN · On-site

$77K - $106K/yr

Minimum of 5 years of experience in pharmaceutical, biopharmaceutical, or CDMO manufacturing with direct involvement in equipment qualification and validation activities. * Demonstrated hands-on ...

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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.

Aseptic Process Development - CDMO

MEDVACON

IN • On-site

Full-time

Posted 29 days ago


Job description

Company Description
MEDVACON Life Sciences works with many leading pharmaceutical companies to hire consulting, contract and full-time employees to join client organizations.
Our focus is cGMP Quality and Compliance, Validation and Regulatory for pharmaceutical and biotechnology companies.
Our leading CDMO client is eager to hire an Aseptic Downstream Process Development SME for their Indianapolis site. This is a full-time role directly with the client - an outstanding opportunity to join an innovative company developing brilliant biotechnology.
A successful background will be strong in Lab, Process and Analytical development including working knowledge of cGMPs related to the production of viral therapeutics and the ability to interface successfully with multi-disciplined teams.
Job Description
Direct the development and establishment of processes in GMP.
Accountable for developing a scalable platform for viral vector production processes that minimizes the risk during Process Development to GMP scale-up.
Provide technical expertise and leadership in science & technology and requires close collaboration with internal stakeholders.
If you're interested so far - apply! A member of our talent team will contact you and share comprehensive job details.
Qualifications
Bachelors Degree
5+ years exp in a cGMP pharma/biotech setting
Solid foundation in the fundamentals of biochemical engineering, virology and cell biology
Pharmaceutical industry experience in technical support of cGMP manufacturing and/or process development, including experience with Contract Development and Manufacturing Organizations
Experience with cell culture technologies, molecular biology, and aseptic processing
Additional Information
Please attach a WORD resume to your submission
All of your information will be kept confidential according to EEO guidelines.
ON-SITE only
This is a FT role and will include a full benefits package
40-hour week
NO AGENCIES please