Biologics Jobs in Hyderabad

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

Job Opening: Manager, Regulatory Affairs - CMC Location: Hyderabad, India | Full-Time About the Role The Manager, Regulatory Affairs - CMC, is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products, in accordance with global regulations and defined regulatory strategies. This role will involve preparing and reviewing the necessary information for the development of regulatory CMC dossiers for commercial products. Our Regulatory Affairs team is dedicated to advancing medical breakthroughs by facilitating communication and procedures that ensure swift, organized compliance across regulatory agencies. As part of our international network, you will play an integral role in ensuring the compliance and approval of medical products, helping to provide reliable healthcare solutions to the world. Primary Responsibilities Regulatory Responsibilities: Provide input to global product and project regulatory strategies by assessing CMC changes and identifying global regulatory requirements. Lead the development, authoring, and review of CMC submission components and documentation to support post-approval supplements, variations, annual reports, registration renewals, and responses to health authority questions. Liaise with global CMC, Manufacturing Divisions, and external partners to ensure compliant execution of change management. Assess and communicate potential regulatory risks and propose mitigation strategies. Ensure timely delivery of all regulatory milestones for assigned products across the product lifecycle. Identify and communicate potential regulatory issues to GRACS CMC management as needed. Technical Skills: Review scientific information to assess the technical merits and suitability of scientific rationale, ensuring clarity and support from data. Demonstrated ability to communicate issues succinctly and logically, both orally and in writing. Solid understanding of related fields such as pharmaceutical manufacturing, analytical testing, and quality assurance. Proficient in operating electronic document-based GMP systems. Leadership Skills: Ability to generate innovative solutions to problems and effectively communicate with key stakeholders. Demonstrated flexibility in adapting to changing priorities and dealing with unexpected events. Capability to handle multiple priorities and balance work to achieve business goals. Effective leadership, communication, and interpersonal skills. Qualifications & Skills Bachelor's degree in Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry. Minimum of 5-7 years of experience in the pharmaceutical industry, with at least 4 years of experience in managing CMC regulatory submissions for small molecules, vaccines, or biologics. Ability to travel to other CMO sites on a need basis. Join a global company that is leading the charge in medical advancements. Play a vital role in ensuring compliance and regulatory success for life-changing pharmaceutical products. Collaborate with diverse teams to drive innovation and shape the future of healthcare. We are proud to be a company that embraces diversity and fosters an inclusive environment. At our organization, the fastest breakthroughs come when diverse ideas come together. We encourage our colleagues to challenge each other s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to promoting diversity and inclusion in the workplace. What We Look For If you re passionate about regulatory affairs and ready to make a meaningful contribution to the global pharmaceutical landscape, join us. Your expertise will help shape the future of medicine and impact generations to come. Qualification : Bachelor's degree in Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.

Job Opening: Process Knowledge Management Specialist Location: Hyderabad | Full-Time About the Role The Process Knowledge Management (PKM) Specialist will act as a subject matter expert for authoring and updating Emerson DeltaV PKM process templates, process recipes, and associated master data. The primary responsibility is to ensure that Process Recipes within DeltaV PKM are successfully and compliantly designed, developed, deployed, and supported to maximize business benefits, aligning with enterprise business process and technical standards. DeltaV PKM is a new capability being developed by Emerson. This role offers the opportunity to work closely with the Emerson development team, shaping the future direction of the product. Primary Responsibilities Support DeltaV PKM training, collaboration, benefit realization, and standardization while adhering to standard processes, cGMP regulations, SOPs, and global business processes. Identify and implement continuous process improvement opportunities to enhance system performance and user experience. Assist in defining and implementing an SDLC strategy that supports the flexible use of DeltaV PKM capabilities across the development spectrum. Sustain Process recipes and master data, combining knowledge of manufacturing processes with DeltaV PKM capabilities and standards. Execute appropriate change control and life-cycle actions to ensure that the DeltaV PKM system remains in a state of control and compliance. Collaborate with teams to troubleshoot and resolve user issues efficiently, ensuring quality decisions and regulatory compliance. Provide assurance on quality systems and regulatory standards, supporting development teams and their respective quality units in fostering quality decisions. Education Bachelor s Degree and at least 5+ years of relevant experience with life sciences systems or 7+ years of relevant experience in life sciences systems. Required Experience and Skills Proven track record of analytical skills, problem-solving abilities, and attention to detail. High personal integrity, credibility, and energy with the ability to work independently and in a team environment. Excellent communication and influencing skills while working with global stakeholders (North America). Strong written and verbal communication skills, with a minimum of five (5) years of experience in a production-regulated industry. Strong understanding of manufacturing principles and processes (preferably Biologics) and ability to translate manufacturing requirements into Automation/Digital Solutions. Preferred Experience and Skills Knowledge of SAP. Knowledge of Pharmaceutical Technology Transfer processes. Be part of a dynamic, innovative company shaping the future of Process Knowledge Management. Work with cutting-edge technology in a regulated industry, contributing to significant advancements in life sciences. Collaborate with a team of dedicated professionals who value integrity and quality in everything we do. Emerson is a leader in life sciences and process control technology. We are committed to developing innovative solutions that drive global success in the manufacturing of life-saving products. Our team s collective efforts help bring critical advancements to the world of healthcare. Qualification : Bachelors Degree and at least 5+ years of relevant experience with life sciences systems or 7+ years of relevant experience in life sciences systems.