Maxim Robillard
Cmc & Compliance Senior Manager @Turnstone Biologics
Signup · Get unlimited contacts
WORK HISTORY
Cmc & Compliance Senior Manager @Turnstone Biologics
Ottawa, CA
Lead Raw material quality management to meet compendial and regulatory requirements • Lead researching, compiling, and reporting of QC compliance standards for testing, daily exposure limits, compendia requirements, etc • Lead sterility assurance projects, including management of APQ program and microbial excursion investigations, partnering closely with the manufacturing teams to ensure compliant execution and resolution of excursions • Maintain and manage microbial control strategy for production processes from incoming raw materials through to final product release. • Support the development and definition of the CMC content requirements based on regulatory and CMC strategies for timely submission of regulatory filings • Partnering with the regulatory team to coordinate TechOps information for regulatory submissions (including amendments, change notifications, information requests, new submissions) • Lead cross functional collaborations to coordinate gathering of key source documents, peer review of CMC content • Write and review CMC content as well as coordinating authoring of technical & regulatory documents led by engineers and scientists within Technical Operations (For Example sections relating to QC testing, test method qualification/ validation, impurities, raw materials, risk assessments, process development reports and analytical method reports supporting submission) • Work with Regulatory to maintain risk register, CMC commitments to regulatory bodies, and monitor the completion of commitments • Work with Regulatory to ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations • Support response strategy, assemble supporting data, draft and manage responses to CMC queries and requests for Information received from global health authorities
EDUCATION
Université de Sherbrooke
Bachelor's degree, Génie des procédés et biotechnologies
Cégép de l'Outaouais
Diplôme d'études collégiales, Sciences de la nature, 32.1 cote R
ABOUT MAXIM ROBILLARD
A passionate and dedicated manager and bioprocess engineer, with ten years of experience in the pharmaceutical manufacturing industry. I have worked for medium to large scale pharmaceutical and cosmetic companies producing TIL Therapy, Vaccinia virus, monoclonal antibodies and cosmetics. I have several relevant experiences as a Senior Manager in the pharmaceutical/biotech sectors and thrive to achieve greater goals within the biotechnology sector. I am always willing to learn and progress and I believe that a great company should focus on inspiring its collaborators in order to motivate them.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.