Navneet Sharma Email and Phone Number

- Consulting w.r.t ACMPR (Helped many companies particularly on this subject)- cGMP and audits to verify if the facilities comply- cGLP and audits for laboratories- cGCP and audits to verify if the clinical trials comply

www.thera-biotech.com

Biochemistry and Molecular Biology

Providing QC and QA services to HTC at both locations in Canada (SK) as well as in the USA (CA).

- In-charge of QC Labs performing all the RM and FP analysis as per Pharmacopeial guidelines- In-charge of QA Unit performing CAPA, OOS, APRs and other related QA functions- In-charge of RA function taking care of all the HC inspections, audits and compliance issues

Research in the field of Biochemistry and Molecular Biology

• Developed production process including downstream purification process in a large fermentation (10,000 L x 7) facility for the production of Cephalosporin C. Responsible for fermentation process as well as purification. Introduced new technologies such as scavenger column (a column for the removal of excess color and impurities) for improvement in purification• Involved in the industrial production of Penicillin acylase and immobilizing it on acrylonitrile beads after purification. Used immobilized enzyme for the bioconversion of Penicillin G into 6-APA and 7-ADCA.• Provided Quality oversight of all the upstream batches and all the downstream processing before transferring to Quality control for final testing. Introduced HPLC in-process control to monitor quality• Reviewed quality of the batches and supported validation by generating a validation report at the end. Provided support to the Process validation and optimization of the raw material usage including fermentation components.• Provided oversight of the regular running of the plant along with the routine operations like sterilization, making up raw materials for a batch, filling up batch sheets, regular meeting with utilities & maintenance staff, updating of the plant operations to the seniors and routine shutdown and maintenance of the plant.

1. Performed R&D work for the fermentation development of Cephalosporin C fermentation at lab-scale (500 mL) and developed the process to industrial scale (3000L)2. Optimized downstream processing components of cephalosporin C production process 3. Developed several analytical methods including methods for the determination of the content of Cephalosporin-C and the impurities by HPLC.4. Developed biocatalysis process for conversion of Cephalosporin C into 7-ACA as per the technology provided by M/S Boehringer Mannheim, Germany.

Junior Research Fellow and Senior Research Fellow