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5.0 - 9.0 years
0 Lacs
karnataka
On-site
Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, Collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy. Working at Immuneel promises the excitement of an agile start-up on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in experience and perspectives. We value work-life balance and believe that having fun on the job is integral to achieving the right results. We pride ourselves on providing an open environment and our mission resonates with humanity everywhere. At Work, we are passionate in driving patient outcomes, responsible and accountable, transparent, honest, and supportive in how we work together, inclusive and flexible. Immuneel prides itself as an organization that is keeping pace with best practices in organization design. Our role-based organization incorporates global trends in human capital that promote focus on work and greater nimbleness. We are currently seeking a Specialist - Quality Control (Molecular Biology) to join our Quality Control department. The primary responsibility of this role will be hands-on wet lab analysis and managing the molecular biology team. The candidate will focus on the development, qualification, and validation of molecular biology/genomics assays to test samples and generate quality control reports. Responsibilities also include carrying out molecular biology workflows and qPCR/ddPCR-based assays to support various tests under safety test panel required for Quality Control and Release/Testing of Cell Therapy products. Coordination of sample management activities of QC is also a key responsibility. Key Responsibilities: - Perform hands-on experiments, validation, quality checks and guide the team. - Serve as subject matter expert for the genomics, analytical & molecular biology-based QC assay requirements. - Design, verify, qualify, and validate assays within the target timeline. - Maintain/compile/archive records, process logs, asset logs, soft copy of QA approved data, ATRs, and lab notebooks. Primary Objectives: - Reconciliation of samples received, used for assays, remaining samples. - Coordination between QC and QA team for issuance of ATRs, collection, and verification. - Preparation of Certificate of analysis from QC in coordination with QA. - Supervise and manage function-specific inventory, material supply, and equipment upkeep. - Management of QC molecular biology team with instrument & consumable suppliers/vendors. Competencies Required: - Technical Competencies: Expertise in molecular Biology and biotechnology, managerial experience of a team, analytical ability, experience in Quality Management Systems and audits. - Soft Skills: Good communication skills, presentation skills, collaborative, assertive, decisive, stress management, ambiguity handling, problem solver, strategic thinker. Qualifications: - MSc or Ph.D. in Molecular Biology or Biotechnology. - Industrial Experience in Biopharmaceutical Sector or cell and gene therapy. - Experience in GMP or GLP environment or laboratories with aseptic sample handling/processing facilities. Working Conditions: - Role Type: Full Time and Onsite. - Work Hours: General Shift 9:00 AM to 6:00 PM, Post-Noon Shift 2:00 PM to 11:00 PM on a rotational basis. - Travel Requirements: No and 0% travel. - Base Location: Immuneel Therapeutics Private Limited, Bangalore. If you are a talented professional with a zeal for healthcare and an out-of-the-box thinker, we invite you to join us and be a part of a historic initiative in India. Send your resume to careers@immuneel.com. Join us in the next revolution in cancer treatment!,
Posted 1 week ago
3.0 - 7.0 years
0 Lacs
karnataka
On-site
As a Manufacturing Associate Specialist specializing in cell therapy (CAR-T) programs at Dr. Reddys Laboratories Ltd., you will play a crucial role in the GMP Manufacturing operations, Technology transfer, risk assessments, quality control, supply chain logistics, and process validation of the CAR-T process for Cell therapy programs. Your primary responsibilities will include performing aseptic T-cell culture processes, operating and maintaining laboratory and manufacturing equipment, following Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), developing and optimizing manufacturing protocols, and ensuring adherence to regulatory requirements. You will be responsible for maintaining detailed records of manufacturing processes, managing raw materials for production, identifying and resolving technical issues during manufacturing, participating in experiments for process development, and supporting routine processes and data analysis. Collaboration with cross-functional teams, training and supervising junior staff, and assisting in lab management duties will also be part of your role. To qualify for this position, you should have a Ph.D/MSc/BSc in a relevant area of Cell and Gene Therapy, Biological Sciences, or equivalent experience in the biotech industry. Technical skills required include expertise in T-cell Engineering, molecular level techniques, cellular assays, phenotyping, molecular assays, biology, and experience in automated manufacturing workflows. Strong interpersonal skills, organizational skills, communication skills, problem-solving abilities, and the capability to work in a fast-paced industrial environment are essential for success in this role. At Dr. Reddy's, we believe in providing our employees with opportunities to work on impactful projects that contribute to the success and growth of our new modalities. We encourage creativity, open-mindedness, and a collaborative spirit to drive the company's achievements in the dynamic field of Cell and Gene Therapy. Join us in accelerating access to affordable and innovative medicines because Good Health Cant Wait.,
Posted 1 week ago
5.0 - 9.0 years
0 Lacs
karnataka
On-site
You will be joining our team as a Deputy Manager/Manager, Analytical method transfer, responsible for delivering developed analytical assays from R&D scale to GMP-compliant commercial quality control labs. Your role will involve overseeing projects related to analytical method transfer, collaborating with cross-functional teams, and ensuring technology transfer and assays qualification activities are conducted in compliance with GLP and GMP standards. The ideal candidate will possess expertise in cGMP, regulatory requirements, technical troubleshooting, method transfer, method validation, technology transfer, and laboratory techniques to support routine testing and release of research and cGMP grade materials. You will be directly involved in drafting technology transfer documents, risk assessments, process FMEA, method validation protocols, facility fit assessments, and other related activities necessary for the release and testing of microbial and mammalian fermentation-based products. You should have familiarity with analytical assays such as HPLC, GC, SDS-PAGE, agarose gel electrophoresis, densitometry, dd-PCR, RT-PCR, ELISA, UV-Visible spectrophotometry, western-Blot, as well as microbiological techniques like BET, BioBioburdend Sterility testing. Additionally, the position may entail assisting in cell bank testing and release under cGMP regulations and coordinating with third-party collaborators for external testing as needed. Your responsibilities will also include authoring and reviewing research studies, compiling experimental data, and contributing to protocols, study reports, and publications with minimal supervision. You will work as part of the method transfer and method validation team, ensuring timely and successful completion of process transfers while addressing any unexpected technical challenges. We are looking for individuals who are enthusiastic, highly motivated, and capable of multitasking. The role requires working collaboratively within a team environment and independently across various aspects of projects related to microbial-derived products.,
Posted 1 month ago
7.0 - 13.0 years
0 Lacs
hyderabad, telangana
On-site
You will be joining USP's Global Biologics department as a Sr. Scientist - I (RSS-Review), where you will play a crucial role in supporting the development of USP documentary standards and reference standards for biological products. In this hands-on, non-supervisory position, you will be responsible for ensuring the accuracy, clarity, and compliance of scientific documents, managing the reference standard stability program, and driving continuous process improvements. Your primary responsibilities will include performing technical and quality reviews of documents, developing and reviewing SOPs and training materials, assisting in investigations of quality-related issues, and collaborating with internal stakeholders to develop new standards for analytical analysis of biological products. You will also be involved in maintaining the reference standard stability program, reviewing testing data, preparing stability trend reports, and updating databases to document laboratory data and program determinations. To succeed in this role, you must have a PhD degree in Biochemistry/Biology/Pharmacy or a related field with 7 to 10 years of experience, or a Master's degree with 11 to 13 years of experience. You should have demonstrated expertise in technical review of analytical documents in Quality Assurance and hands-on experience with analytical techniques for characterizing biological products. Strong communication skills, both written and verbal, along with the ability to work collaboratively with internal and external stakeholders, are essential for this position. Additionally, knowledge of USP products and services, experience in the pharmaceutical or biotechnology industry, and the ability to work effectively in a fast-paced environment are desired preferences. While there are no supervisory responsibilities associated with this role, you will be expected to take ownership of your work, ensure timely delivery of tasks, and maintain the highest quality standards. USP is committed to providing comprehensive benefits to protect the well-being of you and your family, including paid time off, healthcare options, and retirement savings. By joining USP, you will contribute to the organization's mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs.,
Posted 1 month ago
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