Aseptic Process Development - CDMO

MEDVACON; Indianapolis (IN); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

MEDVACON Life Sciences is seeking an Aseptic Downstream Process Development SME for an Indianapolis site. The role focuses on directing GMP process development and establishing scalable viral vector production processes to enable GMP-scale manufacturing.

The ideal candidate has 5+ years in cGMP pharma/biotech, with strong grounding in biochemical engineering, virology, and cell biology, plus experience in aseptic processing and cell culture technologies. On-site role with full benefits.

Formación

• 5+ years of experience in a cGMP pharma/biotech setting.
• Strong fundamentals in biochemical engineering, virology and cell biology.
• Experience supporting cGMP manufacturing or process development, including CDMOs.
• Experience with cell culture, molecular biology, and aseptic processing.

Responsabilidades

• Direct development and establishment of GMP processes.
• Develop scalable platform for viral vector production processes to enable GMP scale-up.
• Provide technical leadership and collaborate with internal stakeholders.

Conocimientos

biochemical engineering

virology

cell biology

cell culture technologies

molecular biology

aseptic processing

Descripción del empleo

MEDVACON Life Sciences works with many leading pharmaceutical companies to hire consulting, contract and full-time employees to join client organizations.

Our focus iscGMP Quality and Compliance, Validation and Regulatory for pharmaceutical and biotechnology companies.

Our leading CDMO client is eager to hire an AsepticDownstream Process DevelopmentSME 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 developmentincluding 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.

Qualifications

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

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