Biotech downstream Specalist

CURRICULUM VITAE

NISAR YASIN MULANI.

Email: *****.******@*****.***

Mobile: 080******** and or 097********.

EDUCATIONAL QUALIFICATION:

M.Sc- Biotechnology, S.R.T.M.University Nanded (2006-08)

B.Sc-Biotechnology, Pune University (2003-06)

OBJECTIVE: - To work in organization with professional environment and excellent growth opportunities where I can refine my skills for the development of organization.

KEY EXPERIENCE:

Experience

Organization

Industry

Role

Functional

Biocon Limited Bangalore.

(leading Insulin manufacturer)

Biopharma Company engaged in Production of Human insulin

(r-DNA)

Working with Production

for human Insulin and its Analogs and mainly looking in Downstream Process

FUNCTIONAL EXPERIENCE:

Duration: March 2010 to till date

Role: Executive Production

Organization: Biocon Ltd, Bangalore.

Reporting to: Manager Production

FUNCTIONAL SKILLS:

• Responsible for producing Human Insulin (rDNA) and its analogues Aspart, Lispro, Glargine bulk crystal with life threatening medical conditions.

• Interfacing with highly automated production system, controls and maintaining areas in a high state of inspection preparedness.

• Performing CIP and SIP for all portable tanks by operating the distributed control system via a Man Machine interface (MMI) for equipment operation.

• Assembling and preparing for autoclaving and depyrogenation.

• Operating large scale RPHPLC chromatography system (from NOVASEP-FRANCE 40L & 70 Column volume),

• Ion exchange chromatography from Pall Life Science (282.7L Column Volume , 1.2m diameter, Largest column in India.) and AMERSHAM PHARMACIA(125L Column volume, 80cm diameter)

• Preparation of production schedule and implement for activity

• Panel operation & unit monitoring of production activity for processing of pharma and products using cGMP standard while maintaining the production schedule.

DOCUMENTATION & CGMP:

• Preparation of Batch Manufacturing Records (BMRs) and review of filled records.

• Online and final review of BMR along with logbooks

• Preparation and review of SOPs, EOPs, Protocols and Process checklist

• Review of Change control and Deviation

• Working in Process Validation team as a Production representative.

• To ensure compliance to cGMP & documentation thereof for various formulation activities.

• To ensure compliance to various in-process control instructions provided in the batch record

EQUIPMENT OPERATION & MAINTENANCE:

• Westfalia Separator HFA65 (nozzle bowl centrifuged),

• Bioprocess Pharmacia unit -Ion exchange chromatography (1.2m diameter & 282.7litre from Pall Life science) and ( 80cm diameter &125litre column volume Bioprocess glass column from Amersham Pharmacia),

• Disc Stack Centrifuge 20 Kg Capacity (Alfa Laval)

• Production scale Reverse phase high pressure liquid chromatography unit (40 & 70 liter column –RPHPLC unit from NOVASEP-FRANCE),

• Sterile Cartridge filtration,

• Freeze dryer, Autoclave, Hot air oven and Fumigator.

AUDIT FACED:

Worked during various Quality & Regulatory following audits.

• Internal Audit: Cross Functional

• External Audit: FDA, CDSCO and DCGI.

• Supplier Audit: Pfizer, Iran (MOH), Saudi (MOH) and Mexico.

ACADEMIC PROJECT:

• Successfully Completed Project on “Russell’s viper venom Characterization and Antivenom Production Studies” in QC - R & D department at Haffkine Biopharma, Pimpri, Pune

• Training at Serum Institute of India on “Vaccine Production & Q.C. techniques”.

AREA OF INTEREST: Quality Assurance, Regulatory Affairs and Production.

LANGUAGE PROFICIENCY: English, Hindi, Urdu and Marathi.

IT SKILLS: MS Excel, MS Office, Internet & Windows XP.

PERSONAL DETAILS:

Date of Birth: 20th November 1985

Marital Status: Single

Blood Group: B-Positive

PERMANENT ADDRESS: Flat A/2, Sai-Shiv Park, Old Kate-Pimple road

Pimprigaon, Pune-411017, Maharashtra India.

Date

Contact this candidate