Sanjeeva Vara Email & Phone Number

Bengaluru, Ka, In

Hyderabad, Telangana, India

|Unit Manufacturing Head|• Microbial Platform,• mAbs Technology,• Fungal Technology,

Bengaluru, Karnataka, India

Bangalore

As a Group Lead /MSAT – Head responsible for:• Building up, right-sizing, and leading Code manufacturing, MSAT, and Vaccine Manufacturing • Leading the MSAT, R&D, and Manufacturing departments to ensure vaccine development projects are channeled into the manufacturing network and include the Covid Vaccine portfolio’s vaccination strategy in the planning• Preparing of annual production budget to meet the Corporate Business Plan• Complete ownership to produce vaccines at 200L scale including batch planning, budgeting, and manpower management. • Ensuring all the Quality management systems (Track wise, EDMS, ELMS) are in place. Assisted as departmental representative for internal QA audits, EHS audits, and external inspections. • Monitoring production on daily basis and taking action to correct the deviations if any.• Ensuring execution of development batches and Media fill batches. • Plant modification based on the GMP requirement. • As a project leader, developed economic technology for production the of hyaluronic acid including USP, DSP & FD• As a project leader developed formulations and related assays for combination, and multi-dose presentation.• Provides leadership to managers; may also provide leadership to supervisors and professional staff

Bangalore

• Planned for the facility and infrastructure renovation of around 15000sq. ft. • Ensured setting up of cGMP-compliant manufacturing facility for bacterial vaccines. • Improved production process to achieve a 5-time increase in yield of Haemophilus influenzae polysaccharide and achieved 20% Yield in conjugation or PRP-TT.• Led batch formulation activities like raw material verification, and vessel preparation activities like CIP, SIP, PHT, and batch processing activities. • Individual bag sampling, pooling activities, and filtration activity for Mabs. • Ensured Batch readiness for Drug Product 200KL scale. • Improved fermentation process, reduced purification steps to achieve a 6-time increase in yields to typhoid polysaccharide vaccine. • Faced various successful audits from DCG(I), local, and internal consultants.• Designed SOPs and systems to ensure that GMP regulatory requirements are met most efficiently to minimize risks to the operation.

Pune Area, India

• Led and managed the production of polysaccharide vaccines such as Hib at 75g scale and 300g Scale• Played a key role in the production of Men A polysaccharide conjugate vaccine 50g scale• Scaled up and launched the Hib vaccine in 2007 and getting WHO approval for Hib conjugate vaccine. • Preparing process-related documents such as BMR, SOP, and production trend analysis. • Coordinated with quality assurance and quality control for the smooth operation of production. • Root cause analysis and troubleshooting in case of batch failure.

Sera &Vaccine Division - Gaganpahad

• Project leader in developing Hib and economic technology for fermentation, purification, and conjugation at 1g to 5g scale.• Responsible for the process development of Meningococcal Vaccine.• Obtained low Endotoxin level for purified polysaccharide(<2EU)• Conjugation of polysaccharide with tetanus toxoid using different chemical Methods

Master Of Technology - Mtech, Biotechnology

Master Of Technology (M.Tech.), Biotechnology

Bachelor Of Pharmaceutical Science