Job Summary: We are seeking an experienced and strategic-minded Sr. Manager/Manager CMC
Biologics to join our growing organization. In this key lead role, you will be responsible for overseeing all
aspects of Chemistry, Manufacturing, and Controls (CMC) activities related to biologics development
and manufacturing. Your in-depth knowledge of CMC regulatory requirements, scientific and technical
expertise, and project management skills will be instrumental in driving the successful development and
commercialization of our biologics portfolio.
Responsibilities:
 Lead and manage biologics development, process optimization, process characterization and
process validation and technology transfer to ensure the timely and efficient execution of CMC
activities.
 Develop and execute CMC strategies and plans for biologics programs in alignment with overall
project goals, regulatory requirements, and industry best practices.
 Provide technical and scientific review of CMC data generated by CDMOs and external testing
laboratories including review and development of analytical assays, stability data,
characterizations studies, protocols, and technical reports.
 Authoring and review of CMC documentation in eCTD format from source documents (i.e.,
batch records and technical reports) including regulatory submissions (INDs, IMPDs, BLAs &
MAA), and CMC briefing packages for submission to regulatory authorities, ensuring accuracy,
completeness, and compliance with regulatory standards.
 Review and provide scientific and technical expertise on process-related issues, development
and CMC protocols, SOPs, technical reports, development of analytical methods, deviations, out
of specification (OOS) results and corrective and preventive actions (CAPAs) reports from
CDMOs and external vendors to ensure expedited CMC development, product quality and
regulatory compliance.
 Stay abreast of emerging trends, regulations, and technologies in biologics development,
manufacturing, and CMC requirements, and provide strategic recommendations for process
improvements and innovation.
 Manage relationships with external CROs and CDMOs, ensuring effective collaboration, timely
review and project execution, and adherence to quality standards.

Requirements:
 A Ph.D. or master's degree in pharmaceutical sciences, biochemistry, biotechnology, or a related
field. A BS degree with equivalent industry experience will also be considered.
 A minimum of 5 years of progressive experience in CMC biologics development within the
biopharmaceutical industry.

 In-depth knowledge of global regulatory guidelines and requirements for CMC biologics
development, including ICH guidelines, FDA regulations, EMA regulations and regional
variations.
 Strong understanding of biologics manufacturing processes, including cell culture, purification,
formulation, and aseptic processing.
 Demonstrated expertise in CMC technical writing, including the preparation of regulatory
submissions (INDs, BLAs) and other CMC-related documentation.
 Strong project management skills, with the ability to effectively prioritize, plan, and execute
multiple projects simultaneously.
 Excellent communication and interpersonal skills, with the ability to effectively communicate
complex scientific concepts and build strong relationships with internal and external
stakeholders.
 Strong problem-solving and analytical skills, with a data-driven mindset and the ability to make
sound decisions based on scientific, technical, and regulatory considerations.
 Demonstrated ability to work in a fast-paced, dynamic environment, adapt to changing
priorities, and meet challenging deadlines.
If you are a highly motivated and experienced CMC professional with a strong background in biologics
development and a passion for driving innovation in a dynamic industry, we invite you to apply for the
position of Senior Manager CMC Biologics at CanariaBio to contribute to our mission of developing
innovative biopharmaceutical products for cancer.