Job Title: Executive - MSAT (Upstream)
Competencies
Purpose of Job
As a MSAT Executive (Upstream) at Intas Biopharma in Ahmedabad, you will play an instrumental role in supporting and optimizing the manufacturing processes for biopharmaceutical products. This position focuses for continuous process improvement, driving efficient manufacturing solutions, and ensuring consistent product quality.
Skill Required
Technical Skills:
o In-depth knowledge of bioprocessing, upstream process development, Manufacturing and process intensification strategies.
o Expertise in QMS, regulatory requirements (e.g., FDA, EMA).
o Proficiency in statistical software (e.g., JMP, Minitab).
· Soft Skills:
o With the ability to lead and influence cross-functional teams.
o Excellent problem-solving, analytical, and communication skills.
Roles and Responsibilites
· Planning and Execution of all Microbial and mammalian upstream related processes and lab activities.
· Designing and executing experiments for yield and Quality improvement and process intensification of current commercial microbial and mammalian products and protocol based batches execution.
· An executive with extensive expertise in Biologics (Upstream) Development & Manufacturing: Product Technical Life Cycle Management.
· Collaborate with cross-functional teams to facilitate the transfer of upstream processes from development to manufacturing.
· Provide technical expertise in upstream bioprocessing, to optimize manufacturing processes.
· Work closely with development teams to gather and document critical process parameters and data for successful transfer.
· Collaborate with Quality Assurance to ensure compliance with cGMP and other regulatory standards.
· Participate in process validation activities and support the resolution of deviations or discrepancies.
Qualification Required
Education: Master’s in Biotechnology, or related field.
Relevant professional / Educational background
3+ years in biopharma manufacturing in MSAT or process improvement roles.
Biotech, Ahmedabad, GJ, IN, 382213