Sanjeeva Vara Email and Phone Number
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I have extensive experience in aseptic GMP Drug Substance manufacturing, gained from working in a high-tech multi-product facility that produces Clinical Trial Material (CTM), conducts pre-PPQ activities, PPQ production, and commercial production of both Bulk Drug Substance and Drug Products.Currently, I hold a leadership position in a biopharmaceutical company specialising in producing innovative, high-quality products for various therapeutic areas. With over 21 years of industry experience, I am also a certified Six Sigma Green Belt professional. My expertise lies in process chemistry, scale-up, and MSAT.In my present role, I oversee the microbial platform and mAbs technology units. My responsibilities include managing capacity mapping, operational excellence, vendor development, and vaccination strategy for the COVID-19 vaccine portfolio. I have successfully developed and patented several products in the vaccines and biologicals category. This includes a high Mw Sodium Hyaluronate injection through bacterial fermentation. I aim to contribute to the innovation and improvement of biopharmaceutical products and processes to impact human health and well-being positively. I am forward-thinking and enjoy collaborating with internal stakeholders, making appropriate recommendations, and sharing knowledge and experience with my team.I hold a Master's degree in Biotechnology and possess extensive experience in project and line management within aseptic production of Polysaccharide Conjugate Vaccines (subunit vaccines), viral vector vaccines, recombinant protein subunit vaccines, and biosimilars. My experience also includes late-stage product introduction, manufacturing development, and driving the PPQ manufacturing process promptly.My professional competencies include expertise in:- Large-scale mammalian manufacture of Drug Substance- Vaccine manufacturing- Single-Use Technology- Conceptual design of BSL2 facility- Pharmaceutical upgrade/upscale projects- Tech Transfer & upscaling manufacturing processes into existing production- Pharmaceutical processes and unit operations- Operational and project management- Qualification/Validation- GMP compliance- Lean optimizations- EMA/FDA inspections
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Lead Msat And ManufacturingVj Biosciences Private LimitedBengaluru, Ka, In -
Deputy General ManagerMsn Laboratories Jul 2023 - PresentHyderabad, Telangana, India|Unit Manufacturing Head|• Microbial Platform,• mAbs Technology,• Fungal Technology, -
Senior Group LeaderStelis Biopharma Apr 2018 - Jul 2023Bengaluru, Karnataka, India -
Group LeadStelis Biopharma Nov 2012 - Apr 2018BangaloreAs 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
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Asst.General ManagerRanbaxy Sep 2010 - Oct 2012Bangalore• 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. -
Asset ManagerSerum Institute Of India Limited Apr 2007 - Sep 2010Pune 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. -
ExecutiveBiological E. Ltd Sep 2003 - Feb 2007Sera &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
Sanjeeva Vara Skills
Sanjeeva Vara Education Details
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Jawaharlal Nehru Technological University Hyderabad (Jntuh)Biotechnology -
Biotechnology -
Bachelor Of Pharmaceutical Science
Frequently Asked Questions about Sanjeeva Vara
What company does Sanjeeva Vara work for?
Sanjeeva Vara works for Vj Biosciences Private Limited
What is Sanjeeva Vara's role at the current company?
Sanjeeva Vara's current role is Lead MSAT and Manufacturing.
What is Sanjeeva Vara's email address?
Sanjeeva Vara's email address is sa****@****ail.com
What schools did Sanjeeva Vara attend?
Sanjeeva Vara attended Jawaharlal Nehru Technological University Hyderabad (Jntuh), Jawaharlal Nehru Technological University, Osmania University.
What skills is Sanjeeva Vara known for?
Sanjeeva Vara has skills like Upstream Processing, Downstream Processing, Analytical Method Validation, Analytical Methods Development, Conjugation, Purification, Gmp, Internal Audit, Sop, Protocol, Scaleup, Glp.
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