Biotechnology Jobs in Hyderabad

8 Jobs Found

AI

Sr. Associate Regulatory Affairs

Amgen Inc

1-2 Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, post market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master s degree OR Bachelor s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms Qualification : Bachelors degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Sr. Associate Sr. associate Regulatory Regulatory associate
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Regional Manager Core Diagnostics

Agappe Diagnostics Ltd

2+ Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Job Title: Regional Manager Core Diagnostics Locations: Hyderabad Experience Required: 2 4 Years Industry: In Vitro Diagnostics (IVD) / Healthcare / Medical Devices Employment Type: Full-Time Job Overview We are looking for an ambitious and results-driven Regional Manager to lead sales and business development efforts for our Core Diagnostics division across Hyderabad and Ahmedabad regions. The ideal candidate will have a strong background in IVD sales, relationship management, and regional business expansion, with the ability to drive growth in a competitive diagnostics market. Key Responsibilities Drive sales growth and achieve revenue targets for the Core Diagnostics product line in the assigned region. Build and maintain strong relationships with hospitals, diagnostic labs, and channel partners. Identify new business opportunities and expand market presence in the IVD and healthcare diagnostics sector. Develop and implement territory-specific sales strategies and account plans. Conduct regular product presentations, demos, and training for clients and internal stakeholders. Collaborate with the marketing, technical, and operations teams to ensure smooth execution of regional strategies. Monitor competitor activities and market trends to identify challenges and areas for improvement. Maintain accurate and timely sales data in CRM tools and provide regular reports to senior management. Qualifications & Skills Education: Degree in Medical Laboratory Technology (MLT), Biomedical Engineering, or Pharmacy. Experience: Minimum 2 years of proven experience in IVD sales, preferably in a regional or field role. Strong knowledge of diagnostic instruments and reagents. Excellent communication, negotiation, and interpersonal skills. Ability to work independently and manage a regional territory effectively. Willingness to travel extensively within the assigned geography. Key Competencies Strategic account management Field sales and territory development Product knowledge in clinical diagnostics/IVD Goal orientation and performance-driven mindset Customer relationship and stakeholder engagement Work with a leading name in the IVD and diagnostic industry Opportunity to make a significant impact in a growth-focused environment Competitive compensation and performance-based incentives Collaborative culture with training and development support Apply now and help shape the future of diagnostic healthcare in India. Qualification : Degree in Medical Laboratory Technology (MLT), Biomedical Engineering, or Pharmacy.

Manager Regional manager Core Core manager Diagnostics
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Consultant, Life Sciences Consulting

Epam Systems

6-12 Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

We are seeking a dynamic Consultant to lead our team in implementing SAPIO Sciences LIMS and ELN solutions for our clients. This position entails designing solutions and configuring SAPIO Sciences systems to align with client requirements in lab informatics. The ideal candidate will bring a wealth of technical expertise and leadership skills to successfully deliver SAPIO LIMS and ELN projects. Responsibilities Lead SAPIO Sciences LIMS and ELN project implementations Customize and script SAPIO functionalities using Python, JavaScript, and SQL Manage integration of systems using RESTful APIs, Webhook, and web services Utilize port forwarding tools such as ngrok or Cloudflare to facilitate effective system communications Oversee database management for projects, specifically with PostgreSQL or similar technologies Implement cloud deployment strategies for SAPIO solutions using AWS, Azure, or GCP Configure and maintain Gunicorn application servers and ensure smooth operation of Flask/Django frameworks for web applications Set up and manage Nginx reverse proxy servers to optimize system performance Understand and implement lab workflows, sample accessioning, and efficient lab data management practices Ensure compliance with industry standards like GxP, FDA 21 CFR Part 11 in regulated environments Requirements 6 to 12 years of experience in Lab Informatics or related fields Strong technical expertise in SAPIO Sciences LIMS and ELN implementations Background in programming with proficiency in Python, JavaScript, and SQL Extensive experience with databases, focusing on PostgreSQL or equivalent Proficiency in cloud technologies including AWS, Azure, and GCP Excellent capability in managing API integrations and utilizing port forwarding tools Strong knowledge of reverse proxy servers (Nginx) and Python web application servers (Gunicorn) Competency in understanding and managing lab workflows and data management processes Background in working within regulated industries like Pharma, Biotech, etc Nice to have Knowledge of other LIMS/ELN platforms (LabWare, LabVantage) Certification in SAPIO Sciences or related tools Familiarity with laboratory instrument integration We offer Opportunity to work on technical challenges that may impact across geographies Vast opportunities for self-development: online university, knowledge sharing opportunities globally, learning opportunities through external certifications Opportunity to share your ideas on international platforms Sponsored Tech Talks & Hackathons Unlimited access to LinkedIn learning solutions Possibility to relocate to any EPAM office for short and long-term projects Focused individual development Benefit package: Health benefits Retirement benefits Paid time off Flexible benefits Forums to explore beyond work passion (CSR, photography, painting, sports, etc.) Qualification : 6 to 12 years of experience in Lab Informatics or related fields

Consultant Sciences Life Sciences Consulting Life sciences consulting
AI

Sr Validation Engineer

Amgen Inc

4-12 Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Let s do this. Let s change the world. In this vital role you will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes in tools like Veeva Study Startup. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated. Roles & Responsibilities: Collaborate with System Architects and Product owners to manage Validation strategy and Deliverable for the GxP applications. Defining the scope, objectives, and approach of the validation process, creating detailed validation plans, and aligning them with project timelines and resources Perform Validation testing, including Installation Qualification (IQ), Operational Qualification (OQ) for new and existing SSU Systems Ensure compliance with industry standards, regulations and internal policies during all validation activities. (GxP, FDA 21 CFR Part 11) Identify, document, and track defects during the testing process. Collaborate with development teams to define validation requirements, resolve defects and validate fixes. Maintain comprehensive audit trails and validation documentation to support regulatory inspections. Configure and optimize workflows within the Veeva Vault Management (VVM) to streamline test management and approval processes. Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements. Act as a liaison between technical teams and stakeholders to ensure system requirements are met. Provide training to end-users on Veeva VM Testing Vault functionalities and best practices. Assist in the development and continuous improvement of validation processes and procedures Stay up to date with industry trends, best practices and evolving regulatory needs We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor s degree and 6 to 8 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 10 to 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Must-Have Skills: Solid understanding of GxP regulations, specifically 21 CFR Part 11. Familiarity with GxP Validation management tools such as ALM, Veeva Vault Management etc. Experience in defining and executing validation strategies aligned with regulatory requirements Familiarity with risk-based approaches to validation Experience in creating and executing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)) Excellent documentation and report writing skills Good-to-Have Skills: Proficiency in automation tools, data systems, and validation software. Experience of DevOps, Continuous Integration and Continuous Delivery methodology Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFe for Teams certification (preferred) Veeva VM certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com

Sr Validation Engineer Sr engineer Validation engineer
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Kubernetes Architect

Clovertex

8+ Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Job Description We are seeking a Senior Kubernetes Architect to join our team. In this role, you will not only fine-tune Kubernetes clusters for optimal performance but also lead our Kubernetes adoption strategy and serve as a thought leader in cloud-native technologies. Job Duties and Responsibilities: Kubernetes Cluster Optimization: Design, implement, and optimize Kubernetes clusters to ensure high availability, scalability, and performance. Diagnose and resolve complex issues related to cluster performance and stability. Develop and implement best practices for Kubernetes deployments, including security, monitoring, and management. Strategic Leadership: Define and drive the Kubernetes adoption strategy across the organization. Collaborate with stakeholders to align Kubernetes strategies with business goals and technical requirements. Advocate for and lead the adoption of cloud-native technologies and methodologies. Thought Leadership: Stay abreast of the latest developments in Kubernetes and related technologies. Share insights and knowledge through internal workshops, presentations, and documentation. Contribute to the community through blogs, speaking engagements, or open-source projects. Architectural Design: Create and maintain architectural frameworks and guidelines for Kubernetes deployments. Evaluate and recommend tools and technologies that complement Kubernetes ecosystems. Lead design reviews and provide guidance on complex architectural decisions. Team Collaboration: Work closely with development, operations, and DevOps teams to integrate Kubernetes solutions effectively. Mentor and guide junior team members on Kubernetes best practices and advanced techniques. Facilitate cross-functional collaboration to drive successful Kubernetes initiatives. Qualifications: Experience: 15+ years of experience in software engineering with at least 8+ years focusing on Kubernetes architecture and operations. Proven experience in designing, deploying, and tuning large-scale Kubernetes clusters. Technical Skills: Deep understanding of Kubernetes architecture, including components such as Pods, Services, Deployments, and Custom Resources. Proficiency in containerization technologies (Docker, containers). Experience with CI/CD pipelines, infrastructure as code (IaC), and cloud platforms (AWS, Azure, GCP). Leadership Skills: Demonstrated ability to lead strategic initiatives and drive adoption of new technologies. Excellent communication skills with the ability to influence and guide diverse teams. Education: Bachelor s degree in computer science, Engineering, or a related field (or equivalent experience). Relevant certifications (e.g., Certified Kubernetes Administrator (CKA), Certified Kubernetes Application Developer (CKAD)) are a plus. Benefits: We strongly believe in a competitive salary and benefits package for our employees. Along with the opportunity to work on cutting-edge technologies in the Biotechnology Industry, Clovertex also reimburse AWS certifications at various levels. Clovertex understands the importance of Work Life balance and provides Hybrid work model. Health insurance and benefits for the employees and dependents. Additional Information: Clovertex is an equal opportunity employer and values diversity in the workplace. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating a positive and inclusive work environment for all employees. Qualification : Bachelors degree in computer science, Engineering, or a related field (or equivalent experience).

kubernetes Architect Full-Time Kubernetes Architect K8s
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Cloud Engineer (offsite)

Clovertex

2-3 Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Job Role: Cloud Engineer Key Responsibilities: Design, deploy, and manage AWS cloud solutions for HPC environments, including compute, storage, networking, and security. Implement scalable, reliable infrastructure to support various applications and workloads. Apply AWS best practices for performance optimization, reliability, and cost management. Build and maintain CI/CD pipelines for efficient deployment of applications and infrastructure. Develop and implement CI/CD pipelines tailored for scientific and engineering applications. Diagnose and resolve complex technical issues within AWS environments. Design and implement optimized HPC solutions for scientific and engineering workloads on the cloud. Oversee HPC deployments, ensuring high availability, scalability, and performance. Collaborate with DevOps engineers and developers to ensure seamless integration of HPC solutions. Monitor and troubleshoot HPC workloads in cloud environments. Stay current with advancements in HPC, cloud technologies, and scientific/engineering applications. Document and share best practices related to HPC and cloud integration. Job Requirements: Bachelor s degree in computer science or a related field. 2-3 years of hands-on experience with AWS services (e.g., EC2, S3, IAM, EFS, FSx, VPC). Basic understanding of HPC principles and parallel file systems (e.g., Lustre, GPFS). Experience with Linux system administration. Familiarity with cloud platforms (AWS, Azure, GCP) and HPC services (AWS experience preferred). Proven experience with DevOps pipelines, adapting scientific/engineering applications for the cloud. Strong scripting skills (Bash, Python, etc.). Basic understanding of job schedulers (e.g., Slurm, SGE, PBS). Excellent problem-solving, analytical, and communication skills. Ability to work independently and in a collaborative team environment. Preferred Skills: AWS certifications (e.g., AWS Certified Solutions Architect). Experience with Linux administration. Knowledge of parallel clusters and HPC administration. Familiarity with Slurm job schedulers. Benefits: We strongly believe in a competitive salary and benefits package for our employees. Along with the opportunity to work on cutting-edge technologies in the Biotechnology Industry, Clovertex also reimburse AWS certifications at various levels. Clovertex understands the importance of Work Life balance and provides Hybrid work model. Health insurance and benefits for the employees and dependents. Additional Information: Clovertex is an equal opportunity employer and values diversity in the workplace. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating a positive and inclusive work environment for all employees. Qualification : Bachelors degree in computer science or a related field

Cloud Engineer Cloud engineer Full-Time Offsite Cloud Engineer
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Senior Devops Engineer

Clovertex

8-13 Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Job Role: Senior DevOps Engineer Location: Hyderabad Job Description Sr. DevOps developer you will define designs, provide technical enablement for application components or subsystems for research applications. Your major focus will be on writing code in python or similar and enable integration with various systems. Responsibilities: 8-13 years of experience in (L3 Skills) (AWS, Python, Groovy, Jenkins). Experience working on AWS Cloud platform. Hands-on experience with infrastructure as code tools like Terraform/CloudFormation. Design, test and implement CI/CD including automation using bitbucket/GitHub, Jenkins. Strong programming skills on Python or Groovy or similar Experience working with different AWS services like Ec2, EBS, RDS, IAM, VPC, Lambda, S3, EKS, etc. Experience in building, managing and deployment of Docker images on EKS. Experience in administering both Unix/Linux and Windows operating systems. Prior experience on monitoring and alerting systems like Prometheus/Alert Manager/Grafana Should demonstrate strong Troubleshooting skills. Good to have: Experience with configuration management tools (E.g., Ansible, Chef) Understanding of Monitoring tools (New Relic, PagerDuty, Splunk, CloudWatch etc.) Strong Communication and documentation skills Ability to learn and apply new technologies through self-Learning. Preferred Certifications: AWS Solution Architect Associate or Up / AWS DevOps Associate or Up Benefits: We strongly believe in a competitive salary and benefits package for our employees. Along with the opportunity to work on cutting-edge technologies in the Biotechnology Industry, Clovertex also reimburse AWS certifications at various levels. Clovertex understands the importance of Work Life balance and provides Hybrid work model. Health insurance and benefits for the employees and dependents. Additional Information: Clovertex is an equal opportunity employer and values diversity in the workplace. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating a positive and inclusive work environment for all employees.

Senior DevOps Engineer Senior engineer Devops engineer
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Software Devops Development Engineer

Clovertex

Fresher | Not Disclosed | Hyderabad, Telangana, India | Full-time

Job Title: Software DevOps Development Engineer Location: Hyderabad The Software DevOps Development Engineer is responsible for developing and enhancing software solutions to support a secure Software Development Lifecycle (SDLC). This role requires a strong foundation in software development and DevOps practices to facilitate the adoption of the SDLC framework. Job Duties and Responsibilities Develop and Enhance Software: Design, develop, test, and implement software solutions to automate and streamline SDLC processes. Integrate security controls and best practices into software development activities. Collaborate with security teams to ensure software aligns with security standards and requirements. Identify opportunities for software improvement and optimization to enhance efficiency and effectiveness. Support SDLC Framework Adoption: Provide technical guidance and support to development teams in adopting the SDLC framework. Develop and maintain documentation, training materials, and other resources to facilitate framework adoption. Conduct workshops and training sessions to increase awareness and understanding of the SDLC framework. Collaborate with stakeholders to identify and address challenges related to framework implementation. Jenkins Pipeline Development: Design, develop, and maintain Jenkins pipelines for continuous integration and continuous delivery (CI/CD). Automate build, test, and deployment processes to improve software delivery efficiency. Integrate security checks and vulnerability scanning into Jenkins pipelines. Troubleshoot and resolve Jenkins pipeline issues. Scripting and Automation: Write and maintain scripts using Groovy and Python to automate tasks and improve efficiency. Develop custom tools and scripts to support SDLC activities. Integrate scripting solutions with existing tools and systems. Required Skills: Strong software development and DevOps background Proficiency in Jenkins pipelines Expertise in Groovy and Python scripting Understanding of various SDLC methodologies (Agile, Waterfall, etc.) Knowledge of security best practices and tools Problem-solving and troubleshooting skills Excellent communication and collaboration abilities Preferred Skills: Experience with cloud platforms (AWS) Knowledge of containerization technologies (Docker, Kubernetes) Experience with infrastructure as code (IaC) tools (Terraform, Ansible) Benefits: We strongly believe in a competitive salary and benefits package for our employees. Along with the opportunity to work on cutting-edge technologies in the Biotechnology Industry, Clovertex also reimburse AWS certifications at various levels. Clovertex understands the importance of Work Life balance and provides Hybrid work model. Health insurance and benefits for the employees and dependents. Additional Information: Clovertex is an equal opportunity employer and values diversity in the workplace. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating a positive and inclusive work environment for all employees.

Software DevOps Development Software Development Devops development

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