3 Secmals Jobs

You must have experience in analytical development or handling of oligonucleotides method development. Additionally, you should possess experience in characterization techniques related to oligonucleotides. In this role, you will be responsible for providing routine analysis support to the process development team for various projects. It is essential that you have good documentation skills in line with laboratory GMP practices and the ability to understand and adhere to current Good Manufacturing Practices. Your duties will include ensuring compliance with all quality audits, maintaining data integrity, and following ALCOA++ Principles. You will also be required to prepare and review method development reports, method validation protocols, and reports. Experience in method qualification activities is necessary for this position. As part of your responsibilities, you will work with the instruments assigned for analysis and be involved in their calibration. Collaboration with DQA/Plant QC for method transfer will also be expected. Any additional experience in characterization techniques of oligonucleotides and peptides will be considered advantageous. It is preferable that you have experience in amino acids analysis, SEC-MALS, DLS, CE, and other related techniques. Interpretation of characterization data is a crucial aspect of this role, and you should be capable of performing this task effectively.,

You have proven experience working in GMP/GLP and scientific environments. You possess basic knowledge of Spectroscopic and Biophysical techniques, Peptide chemistry, as well as peptide characterization. Your expertise lies in at least one of these subjects. Additionally, you have experience in related compound method development and method validation for Peptide drug products using LC-UV and Amino acid analyzer. Hands-on experience with SEC-UV SEC-MALS, SV-AUC, CE, and data interpretation is also one of your strengths in at least one of the techniques and data interpretation. You are skilled in the preparation and review of method development and method validation reports. Knowledge of ICH guidelines and regulatory requirements for peptide products is part of your expertise. As a team player, you are willing to work at different job locations as per the team's requirement. Furthermore, having knowledge of scientific writing will be a plus. Qualifications required for this role include an M. Pharm/M. Sc degree. Amneal is an equal opportunity employer that values diversity and inclusion, ensuring no discrimination based on caste, religion, gender, disability, or any other legally protected status. The Human Resources team at Amneal partners with all aspects of the organization, driving success through effective and innovative people management for both current and future business needs. The team performs key roles such as: - Executive Role: Specialists in all aspects of people management, providing high-level strategic input into key business decisions. - Audit Role: Ensuring compliance with legal requirements and best practice employment policies and procedures across the organization. - Facilitator Role: Partnering closely with different areas of the organization to support, advise, and enhance their ability to meet objectives through highly effective employment practices in areas like Talent Acquisition, Learning and Development, Reward systems, Performance Management, and Health and Wellbeing. - Consultancy Role: Providing expert advice to the organization and its managers on various aspects of workforce management, employee relations, and performance. - Service Role: Keeping the organization informed and equipped to handle developments impacting employment matters, including changes in legislation and labor market characteristics.,

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.,