Remote Senior Manager, CMC Analytical Sciences

Sabin Vaccine Institute, Inc.; United States; On-site; USD 145,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits package

Flexible vacation and sick leave

Employer-matching 401(k) plan

Job summary

Sabin Vaccine Institute, Inc. is seeking a Senior Manager, CMC Analytical Sciences. This role involves directing analytical activities, developing and validating methods, and ensuring compliance with regulatory expectations. You will collaborate with various teams to support the advancement of vaccine development.

The ideal candidate will have 9+ years in biopharmaceutical development and a solid grasp of current regulatory requirements. A bachelor's degree in a relevant field is required, with an advanced degree preferred. The position offers a remote working option within the US.

Qualifications

• 9+ years in biopharmaceutical product development.
• Experience managing CMC analytical activities.
• Strong expertise in biologics and/or vaccine development.

Responsibilities

• Lead development and validation of analytical methods.
• Author and review regulatory submission sections.
• Oversee ICH-compliant stability programs.

Skills

Project management

Analytical techniques (qPCR, HPLC, etc.)

Biopharmaceutical product development

Regulatory compliance

Education

Bachelor’s degree in biochemistry or related field

Advanced degree preferred

Tools

qPCR/RT-PCR

HPLC

ELISA

Mass spectrometry

Job description

Sabin Vaccine Institute, Inc. is seeking a Senior Manager, CMC Analytical Sciences. This role involves directing analytical activities, developing and validating methods, and ensuring compliance with regulatory expectations. You will collaborate with various teams to support the advancement of vaccine development.

The ideal candidate will have 9+ years in biopharmaceutical development and a solid grasp of current regulatory requirements. A bachelor's degree in a relevant field is required, with an advanced degree preferred. The position offers a remote working option within the US.