Biologics Production
2 days ago
**Job Summary**:
The Executive in the Biologics Production Department will play a crucial role in the manufacturing and production of biologic drugs in Promea. They will be responsible for ensuring the efficient and compliant production of biologics, adhering to quality standards, safety regulations, and production schedules.
**Key Responsibilities**:
- Execute and oversee the manufacturing operations of biologic drugs, including upstream and downstream processes, purification, and formulation.
- Ensure compliance with current Good Manufacturing Practices (cGMP) and standard operating procedures (SOPs) in all production activities.
- Prepare and review production documents, batch records, and production reports, ensuring accuracy, completeness, and compliance with regulatory requirements.
- Collaborate with cross-functional teams, including process development, quality control, and engineering, to optimize production processes and troubleshoot any technical issues.
- Monitor and analyze production data, yield trends, and key performance indicators (KPIs) to identify areas for improvement and implement corrective actions.
- Participate in technology transfer activities, including process scale-up, process validation, and equipment qualification.
- Support investigations of deviations, out-of-specification (OOS) results, and non-conformances, and assist in implementing appropriate corrective and preventive actions (CAPAs).
- Ensure proper documentation and maintenance of equipment, production areas, and production records in accordance with cGMP guidelines.
- Contribute to continuous improvement initiatives, suggesting process enhancements, efficiency improvements, and cost-saving measures.
- Stay updated on industry trends, regulatory requirements, and technological advancements in biologics production, and propose and implement relevant improvements.
**Qualifications and Skills**:
- Bachelor's or Master's degree in Biotechnology, Biochemistry, or a related field.
- Solid understanding of biologics production processes, including cell culture, fermentation, purification, and formulation.
- Familiarity with cGMP guidelines and regulatory requirements specific to biologics manufacturing.
- Experience with bioreactors, chromatography systems, filtration technologies, and other equipment used in biologics production.
- Knowledge of process optimization, scale-up, and technology transfer in biologics manufacturing.
- Strong analytical and problem-solving skills, with attention to detail and the ability to analyze complex data sets.
- Excellent organizational and time management abilities, with the capability to manage multiple priorities and meet production schedules.
- Effective communication and interpersonal skills, with the ability to collaborate and work effectively in cross-functional teams.
- Proficiency in using manufacturing execution systems (MES) and other production-related software.
- Flexibility to work in shifts, including weekends and holidays, as required in a biologics production environment.
-
Senior Biologics Products Manager
1 week ago
Hyderabad, Telangana, India US Pharmacopeia Full time ₹ 12,00,000 - ₹ 36,00,000 per yearDescriptionWho is USP?The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness,...
-
Senior Biologics Products Manager
3 weeks ago
Hyderabad, India U.S. Pharmacopeia Full timeDescription The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and...
-
Senior Biologics Products Manager
2 weeks ago
Hyderabad, Telangana, India U.S. Pharmacopeia Full time ₹ 20,00,000 - ₹ 25,00,000 per yearDescriptionThe U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and...
-
Hyderabad, India Seven Consultancy Full timeJOB DETAILS 1) Set up and conduct biological, microbiological and biochemical tests and laboratory analyses in support of research and quality control in food production, sanitation, pharmaceutical production, biotechnology and other fields.2) Apply methods and techniques such as microscopy, histochemistry, chromatography, electrophoresis and...
-
Hyderabad, India Seven Consultancy Full timeJOB DETAILS 1. Perform routine and non-routine tests and analyses using the appropriate technical equipment and instruments2. Receive or collect, as well as process, samples 3. Calculate test results, and log and report results using a computer 4. Prepare and supervise experiments 5. Perform quality control and calibrate equipment if necessary 6. Maintain...
-
Hyderabad, Telangana, India Amgen Full timeCareer Category Information SystemsJoin Amgens Mission of Serving PatientsAt Amgen if you feel like youre part of something bigger its because you are Our shared missionxe2x80x94to serve patients living with serious illnessesxe2x80x94drives all that we do Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest...
-
Scientist Biological Sciences
15 hours ago
Bachupally, Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full time**Company Description** Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because **Good Health Can’t Wait**. We started in 1984 with a modest...
-
Hyderabad, India Seven Consultancy Full timeJOB DETAILS 1 Knowledge of animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment2 Develop new methods to analyse laboratory generated data to enable the broad use of genetic screening and validation 3 Ensure data generated is communicated in a concise, easy to understand manner to the...
-
Hyderabad, India Seven Consultancy Full timeJOB DETAILS 1) Analyzing and understanding current bio-manufacturing processes and techniques.2) Ensuring all biochemical processes are compliant with environmental regulations and governmental policies. 3) Developing products and waste removal techniques that have fewer negative environmental consequences. 4) Devising, overseeing, and leading experiments,...
-
Copy Of Subject Matter Expert
3 weeks ago
Hyderabad, Telangana, India Dr. Reddy's Laboratories Full timeCompany Description Dr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20...
