Position Overview: We seek a highly skilled and motivated Senior Associate/Manager (CMC)-Operations to
join our team. The successful candidate will be critical in supporting biological drug product development,
CMC operations, and regulatory submissions. The Senior Associate/Manager will contribute to the Chemistry,
Manufacturing, and Controls (CMC) aspects of biologics development, ensuring compliance with regulatory
guidelines and industry best practices. The responsibilities will include identifying new CROs and managing
the existing CROs contracted for the CMC work, assisting in the preparation of CMC modules of regulatory
submissions, ensuring compliance with regulatory requirements, and supporting cross-functional teams in
achieving regulatory milestones for our biopharmaceutical products. This is an exciting opportunity to work
on cutting-edge and innovative projects and significantly contribute to developing and licensing Cancer
biotherapeutics.
Responsibilities:
CMC Development, Operations and Regulatory Support:

 Gather and organize CMC data and documents from internal stakeholders and outside
vendors to support regulatory submissions, including Global BLA and MAA filings.
 Identify new CROs and manage existing CROs contracted for CMC studies, including drug
substance and drug product manufacturers, raw material suppliers, and analytical and
stability testing laboratories.
 Manage stability program for drug substance and drug products and coordinate timely
shipping and follow-up of Investigational Product(s) to external vendors, testing laboratories
and clinical trial sites.
 Assist in the preparation, review, and submission of CMC sections of regulatory filings,
including Investigational New Drug (IND) applications, Marketing Authorization Applications
(MAAs), Biological License Applications (BLAs), and meeting packages for Global regulatory
authorities.
 Assist in the timely submission of CMC-related documents to regulatory authorities,
following established timelines and requirements.
 Support reviewing and assessing manufacturing and quality-related documentation to
ensure compliance with regulatory standards and guidelines.
 Collaborate with internal teams and external vendors to gather necessary data and
information for regulatory compliance purposes and licensing.
 Monitor and stay updated with relevant global regulatory requirements, CMC requirements
for well-characterized biologics and guidelines, and industry trends related to CMC of
Monoclonal antibody therapeutics.
 Assist in analyzing regulatory and CMC changes, change controls, deviation management,
and their potential impact on product development, registration, and commercialization.
 Contribute to developing internal procedures (SOPs) and processes to ensure compliance
with evolving regulatory requirements.

 Facilitate effective communication and coordination between CMC regulatory affairs and
other departments and external CROs (vendors)
 Maintain accurate and up-to-date records of CMC regulatory submissions, correspondence,
and other regulatory-related documentation.
 Support the organization and archival of CMC-related documents following regulatory and
company requirements.
 Assist in the preparation of labeling texts and ensure alignment with regulatory
requirements.

Qualifications:
 Bachelor's degree in a scientific discipline, preferably in Pharmacy, Biochemistry, or a related field.
 Previous experience (minimum three years) in regulatory affairs and CMC of Biologics and CMC
operations or a related area is preferred.
 Familiarity with regulatory guidelines and requirements related to CMC of Biologics, such as FDA,
EMA, or Health Canada regulations
 Strong attention to detail and ability to handle multiple tasks with a high degree of accuracy
 Excellent written and verbal communication skills, with the ability to effectively communicate
technical information
 Proficiency in document management and use of electronic document management systems (e.g.,
eCTD software) and Microsoft office 365
 Ability to work collaboratively in cross-functional teams and adapt to a dynamic and fast-paced
environment
 Strong organizational and time management skills
 Knowledge of Biologics's pharmaceutical development processes and manufacturing principles, i.e.,
Monoclonal Antibodies or Therapeutics Proteins, is a plus.
Note: This job description is intended to convey information essential to understanding the scope of the Sr.
Associate/Manager (CMC Biologics) position. It is not intended to be an exhaustive list of duties,
responsibilities, or qualifications associated with the role; other duties may be assigned as needed.