Multiple Vacancies in Production, QA, R&D in Pharma Drug Manufacturing, Biotechnology, Quality Assurace, Microbiology at ZENOTECH LABORATORIES

Zenotech Laboratories Limited is a Hyderabad based Biotech Company that develops and manufactures generic, oncology & biopharmaceuticals and markets them to people with unmet medical needs around the world. We aim to bring a constant pipeline of new biogeneric products to the market. Zenotech has a full fledged research and development facility for generating recombinant proteins for clinical development. The highly qualified and trained professionals use recombinant DNA technology and cGMP production methods to give the customers generic versions of biotherapeutic drugs comparable to the innovator product in quality, safety and efficacy.

I. STERILE DRUG PRODUCT MANUFACTURING
1.Manufacturing
The candidates must have exposure to Sterile Drug product (Liquid and Lyophitized and Oncology products) manufacturing Pharmaceutical and Biotechnology Industries. They should be well versed with regulatory guidelines, audit compliance and cGMP requirements and have considerable experience in EU, USFDA, MHRA, TGA, MCC, ANVISAetc. audits.
The incumbents should be a B.Pharm/M.Pharm, with 2-15 years experience in Sterile/ Oncology/ Biotechnology Diuy piuduct manufacturing.

2.Quality
The candidates must have relevant exposure to the Analysis of Raw Material, Packing Materials and Finished Products and major audit exposure such as EU, USFDA, MHRA, TGA. MCC, ANVISA etc. They must possess sound technical knowledge about Analytical Method Validation and Stability Analysis - Sterile Drug product manufacturing as well as calibration of equipments/instruments.
The incumbents should have a B.Pharm/M.Pharm/ M.Sc/PhD, with minimum of 2-15 years experience in a reputed Pharmaceutical Company.

II. BIO-TECHNOLOGY
1.Research & Development
The candidates should have experience in at least one of the following fields: Molecular Biology, Bacterial and Mammalian cell culture, Bacterial and Mammalian Fermentation/Bio-reactor, Protein purification, characterization and formulation, Biological assay development, Cell bank characterization, Virology, carbohydrate biology.
The incumbents must have a M.Sc/M.Tech/PhD dogree in any Biological field with 1-15 years of Gxperience. preferably in Bio-tech industries.

2.Quality
The candidates should have experience in different assay systems (re*ll based anri Fl ISA) and/or Analytical analysis for biological drugs. They must have adequate knowledge of different FDA regulations in biological drugs. The incumbents must have M.Sc/M.Tech/PhD in any biological sciences with proven experience in Bio-tech Quality Control/Quality Assurance in a roputod company for 2-15 years.

Go to Next Page for more info...

Subscribe to Pharmatutor Job Alerts by Email

3.Manufacturing (API)
a. Bacterial and Mammalian Fermenter/ Bioreactor: The candidates should possess a sound knowledge and understanding of bacterial/ mammalian fermentation process, all the parameters of fermenter/bioreactor. and bacterial/ mammalian cell growth, etc. They must also be well aware of FDA regulations and cGMP facilities in biological drugs.
The incumbents should have a B.Tech/MTech in Chemical Engineerino/M.Sc/PhD in any biological science with 2-15 years of experience in handling fermenters/bioreactors from small scale (Flask level, 1L, 10L) to large scale 100,500,1500L b. Purification and Process development: The candidates should be well versed with different columns and process used for protein purification, formulation along with the FDA regulations and cGMP work environments. The incumbents should have a M.Sc/M.Tech in any biological scionco with 2 -15 years of experionco in purification process development from small scale to large scale with different Recombinant proteins and Monoclonal antibodies from bacterial and mammalian sources.

III. QUALITY ASSURANCE
The candidates must have in depth knowledge of QMS, regulatory guidelines, audit compliance and cGMP requirements. They must have major audit exposure such as EU. USFDA, MHRA, TGA, MCC, ANVISA etc. and sound technical skills including working knowledge of biologies and pharmaceutical production, quality assurance, and testing technologies.
The incumbents should have a B.Pharm/M.Pharm/ B.Tech/M.Tech/M.Sc/PhD, with 2-15 years experience in QA section of Sterile Drug product manufacturing and Biotechnology Industries.

IV MICROBIOLOGY
The candidates shall be responsible for Preparation and Review of all type Validation protocols & reports. They must have the ability to control activities and possess relevant experience in Fl I. USFDA, MHRA, TGA. MCC, ANVISA, audits as well as be well versed with cGMP and Quality requirements.
The incumbents should have a M.Sc/PhD in microbiology with 2-15 years experience in Sterile Drug products manufacturing.

All positions require excellent communication, Interpersonal and leadership skills. The company provides ample opportunity for learning, broadening exposures and career progression along with a competitive compensation package. Please apply within 10 days to:
Head Human Resources
Zenotech Laboratories Limited
Survey No. 250-252, Turkapally Village, Shameerpeth Mandal,
R. R. District - 500078,
Hyderabad (Andhra Pradesh)
E-mail: humanresources.zenotech@gmail.com