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Quality Control, Pharma Industry, R and D, CSIR, Food Industry, Pathology, Medical Writing, coding

Required Professionals Master's degree in Toxicology, Veterinary Science, Pharmacology, or Life Sciences

Aragen Biosafety Solutions (formerly known as Intox), Pune is Hiring professionals  Masters in Toxicology, Veterinary Science, or Life Sciences for their Test Facility. Details are provided below  1. Key Responsibilities: -Conduct and support Segment I, II, III, and Juvenile Toxicity Studies -Perform and interpret fetal external, visceral, and skeletal evaluations -Analyze maternal, fetal, and reproductive toxicity data -Prepare study plans, protocols, amendments, and GLP documentation -Ensure compliance with OECD GLP principles, FDA 21 CFR Part 58, ICH S5(R3), and OECD guidelines -Manage study deviations, raw data integrity, and client interactions -Compile complete and accurate GLP final reports -Interpret developmental anomalies and reproductive toxicology findings -Utilize electronic data capture systems and statistical tools for data analysis -Coordinate with cross-functional teams and mentor junior staff 2. Qualification & Experience: Master's degree in Toxicology, V...
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Required Assistant Manager-Production - Upstream -Fermentation (Microbial)-M.SC/M.Pharm/ M.Tech (Biotechnology/Biochemistry)

Bachwell Pharma is hiring Assistant Manager - Production Upstream - Fermentation ( Microbial) 
Details are provided below 
1. Position: Assistant Manager-Production - Upstream -Fermentation (Microbial) (01 Vacancies)
2. Department: Production - Upstream (Microbial) - Media Preparation/Monitoring/Technical Operations/Yield Optimization/Documentation & Compliance - for global markets
3. Experience: 7 - 14 years
4. Location: Genome Valley, Hyderabad, India
5. Qualifications: M.SC/M.Pharm/ M.Tech (Biotechnology/Biochemistry)
6. Core Job Responsibilities: 
A. Process Management & Supervision Batch Execution: Overseeing the entire upstream cycle, including
media preparation, sterilization (SIP), inoculum development, and large-scale fermentation.
Parameter Monitoring: Ensuring precise control of critical process parameters (CPPs) such as pH, dissolved oxygen (p02), temperature, agitation, and nutrient feed rates.
Yield Optimization: Analyzing
growth curves and metabolic data to ensure optical density and product titers meet established benchmarks.
Troubleshooting: Identifying and resolving process deviations, such as contamination, foam build-up, or equipment failure (e.g., mechanical seal leaks).
B. Technical Operations (OSD/Injectable Context)
Since microbial fermentation often produces the API for injectables or specialized OSDs, the technical requirements are rigorous:
Equipment Handling: Managing automated bioreactors/fermenters
(stainless steel or single-use), centrifuges, and cell disruption equipment (homogenizers).
Sterilization Protocols: Supervising Validated Sterilization-In-Place (SIP) and Cleaning-In-Place (CIP) cycles to prevent cross-contamination.
Media Optimization: Coordinating the preparation of complex or chemically defined media, ensuring all components are USP/EP grade.
C. Documentation & Compliance (cGMP)
BMR/BPR Review: Reviewing Batch Manufacturing Records (BMR) and Batch Production Records for accuracy and real-time entries.
Deviation & CAPA: Initiating and investigating deviations.
Implementing Corrective and Preventive Actions to prevent recurrence of batch failures.
Audit Readiness: Ensuring the facility is prepared for regulatory inspections (USFDA, EMA, or local authorities). This includes
maintaining logbooks, calibration records, and training files.
D. Leadership & Coordination
Shift Management:
Cross-Functional Collaboration:
Working closely with:
Downstream (DSP): To ensure the harvest is delivered at the right time and quality.
Quality Control (QC):
Maintenance: To coordinate preventive maintenance of fermenters and utility systems (Steam, WFI, Process Air).
Training:
E. Strategic Responsibilities (Assistant Manager Level)
Resource Planning:
Process Improvement:
Cost Control:
7. Key Technical Skills: 
Automation: Familiarity with PLC/SCADA systems and DeltaV or similar Distributed Control Systems (DCS).
8. How to Apply: 
Interested candidates can share their resume at sreddy@bachwellpharma.com, bachwellpharma@gmail.com & hr@bachwellpharma.com

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