Avleen Vishram
Production Manager, Gmp Operations @TriLink BioTechnologies, part of Maravai LifeSciences
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WORK HISTORY
Production Manager, Gmp Operations @TriLink BioTechnologies, part of Maravai LifeSciences
San Diego, CA, US
Led the end-to-end planning and execution of a Phase 2 GMP compliant manufacturing facility expansion, including equipment selection, process flow design, and cross-functional coordination to increase production capacity for mRNA therapeutics.• Hands on experience in GMP manufacturing of mRNA drug substances, covering both upstream and downstream processes, in support of pre-clinical and clinical programs.• Directed the design, build and qualification of Grade B cleanrooms per EU GMP Annex I, enabling sterile fill/finish operations for mRNA-based drug products.• Oversaw implementation of aseptic bag and vial filling operations, ensuring alignment with FDA, EU, and client specific sterility and environmental monitoring requirements. • Ensured strict compliance with cGMP regulations (21 CFR Parts 210/211), ICH Q7, Q8, Q9 and other global regulatory requirements.• Supported the implementation and maintenance of phase-appropriate Quality Management Systems (QMS) including SOP development, change control, document control and batch record review.• Played a key role in successful execution of ISO 9001 annual audits, Qualified person (QP) audit; hosted 25+ customer audits, and contributed to the development and execution of internal audit program. • Partnered cross functionally with Quality Assurance, Engineering, Validation and Regulatory Affairs to ensure successful commissioning, qualification and GMP readiness of the facility.
EDUCATION
Punjab Agricultural University
Bachelor of Science, Biotechnology
Stephen F. Austin State University
Master of Science (MS), Biotechnology
SKILLS
ABOUT AVLEEN VISHRAM
As a Production Manager at TriLink BioTechnologies, I bring over eight years of expertise in cGMP-regulated environments, focusing on Phase I and II mRNA manufacturing. My responsibilities span comprehensive production operations, including upstream and downstream processing, ensuring compliance with FDA, ICH, and global regulatory standards. I am skilled in molecular biology, protein expression, and protein purification, with a strong background in authoring and reviewing GMP documentation, such as SOPs, batch records, and QA reports. I am committed to fostering a collaborative environment that emphasizes staff development, performance optimization, and maintaining the highest quality standards in biotech and CDMO operations.
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