4 Gmp Manufacturing Jobs

Honour CDMO Business : Honour is a leading Contract Development and Manufacturing Organization (CDMO) headquartered in India, serving global pharmaceutical and biotech companies. With integrated capabilities across process development, analytical services, scale-up, and commercial GMP manufacturing, Honour supports its partners throughout the drug development lifecycle. Our mission is to deliver reliable, high-quality, and cost-effective solutions, enabling customers to accelerate molecules from discovery to commercialization. Responsibilities : Identify, evaluate, and develop new business opportunities across the US WestCoast region . Establish, strengthen, and expand client relationships to grow Honours customer base. Generate and manage customer inquiries through virtual and in-person meetings, aligning with Honours manufacturing capabilities and services. Develop opportunities within accounts, coordinate with internal resources, and convert them into successful projects that improve financial performance. Maintain in-depth knowledge of Honours capabilities, capacity, and differentiators, as well as external market trends and competitor landscape. Manage and evaluate customer pipelines in the West Coast territory, working closely with the broader BD team. Represent Honour at domestic and international conferences, exhibitions, and industry forums. Coordinate with cross-functional teams (PD, AD, QA, QC, SCM, Regulatory, Legal) to ensure timely client deliverables and contractual compliance. Support proposal development efforts, ensuring timely, accurate, and customer-focused submissions. Host and coordinate client visits/audits at Honours facilities in Hyderabad and Vizag. Collaborate with marketing to implement campaigns, invite prospective customers to events, and support promotional activities. Screen relevant companies at conferences, identify partnership opportunities, and schedule meetings with key decision-makers. Role : Drive Honours business growth in the West Coast CDMO market by building and sustaining long-term customer partnerships. Translate customer needs into tailored solutions leveraging Honours integrated development and manufacturing services. Serve as the primary point of contact for WestCoast accounts, ensuring customer satisfaction and repeat business. Represent Honour as a trusted partner in the competitive CDMO landscape. Education & Experience : 5+ years of experience in Business Development, Sales, or Account Management in the CDMO/Pharma/Biotech sector. Bachelors or Masters degree in Chemistry, Chemical Engineering, Pharmacy, Biotechnology, or related life sciences. MBA or advanced degree in business/marketing (preferred but not mandatory). Skills & Competencies : Deep understanding of drug development, GMP manufacturing, and CDMO business models. Strong communication, negotiation, and relationship-building skills. Ability to work independently while collaborating effectively with global teams. Strategic mindset with hands-on execution capabilities. Experience managing client contracts and agreements (CDAs, RFIs, MSAs, RFPs, SOWs, POs, Vendor Registration, etc.). Willingness to travel extensively across the US WestCoast and internationally as needed. Show more Show less

Dr. Reddys is looking for Manufacturing Scientists or senior scientists specialized in cell therapy (CAR-T) programs to join their Manufacturing facility team. As a Manufacturing Scientist, you will collaborate with Research and Product Development teams to support GMP Manufacturing operations, Technology transfer, quality assessments, and process validation of the CAR-T process for various Cell therapy programs. Your responsibilities will include designing and executing experiments to develop robust manufacturing processes for cell therapy products, leading and training a team of cell process scientists/engineers, managing T-cell culture and differentiation, documenting experimental procedures and results, supporting the development of SOPs and batch records, and reviewing production batch records for deviations and investigations. You will also be responsible for communicating progress, identifying critical issues affecting supply and timelines, collaborating within departmental teams, contributing to deliverables, serving as a technical subject matter expert for technology transfers, and aligning with leadership to develop a strategic roadmap on continuous medium optimization. To qualify for this role, you should have a PhD/MSc/BSc in biotechnology, biology, immunology, Cell Biology, or a related life-science discipline, along with 5-12 years of industry experience in Cell and gene therapy, biologics manufacturing, or product development functions. Experience in aseptic processing, cell culture, automated equipment, T-cell culture processes, GMP requirements, and DOE is required. Strong organizational, communication, and decision-making skills are essential to succeed in this role. If you are a dynamic individual who can work in a fast-paced environment, collaborate effectively with teams, and drive successful outcomes in manufacturing processes, this position offers an exciting opportunity to contribute to cutting-edge cell therapy programs at Dr. Reddys.,

PopVax, an Indian biotechnology company based in Hyderabad, with a primarily remote US subsidiary nominally located in New York, is seeking a senior regulatory executive. The company is funded through research agreements with the Gates Foundation and Vitalik Buterin's biosecurity company, Balvi. Over the past year, PopVax has been developing a novel second-generation mRNA platform for low-cost broadly-protective vaccines using computationally-driven antigen design. The primary focus is on an open-source booster vaccine candidate designed to provide protection against the entire sarbecovirus species and potentially the betacoronavirus genus, including current and future strains of SARS-CoV-2, the virus responsible for COVID-19. Clinical trials for this candidate are planned to commence later this year. The ideal candidate for this role should possess deep expertise in the end-to-end qualification of novel vaccines and biologics in the US, navigating FDA processes from preclinical development to animal trials, GMP manufacturing, human trials (IND), and licensure (BLA). Additionally, experience with regulatory processes in other stringent regimes such as the European Union (EMA), Canada (Health Canada), the UK (MHRA), and Japan (PMDA) is highly desirable. The candidate should be comfortable working independently in a fast-paced environment without immediate support from a regulatory team or junior regulatory executives. Previous experience in regulatory work for a successfully-authorized COVID-19 vaccine in any of these countries would be a significant advantage. The position offers the flexibility to work remotely from any country worldwide (except those sanctioned by the US in ways detrimental to the role). PopVax provides competitive compensation, comprehensive health insurance covering immediate family members (including pre-existing conditions), and a collaborative work environment dedicated to addressing the cutting-edge multidisciplinary challenges associated with the novel mRNA platform.,

As the QA Oversight Specialist for R&D third parties involved in GMP Manufacturing processes at GSK, your primary role is to ensure the adequate Quality Assurance of services provided by external third-party providers. You will be responsible for managing the Third Party Quality Process to guarantee compliance with GSK quality requirements, cGMP, and regulatory standards. Your duties will include overseeing the release of batches and data in accordance with GMPs and regulatory requirements. Key responsibilities include developing effective processes and procedures in R&D Third Party Quality, contributing to business processes, and providing guidance on quality and compliance policies. You will act as the primary quality contact for assigned third parties or projects, ensuring they operate in alignment with GSK standards. Additionally, you will manage quality governance meetings, handle quality contracts, and oversee deviations, change controls, and validations related to third parties. You will actively participate in the selection and approval of third parties, manage approval statuses, identify and mitigate risks, review documentation for batch release processes, and ensure proper documentation management according to GSK requirements. Collaboration in third-party audit organization, preparation, and execution may also be required, along with participation in product/process transfer teams. In terms of Health and Safety, you will ensure that housekeeping and safety standards are maintained at high levels and that all activities adhere to relevant legislation, GSK safety documents, and local procedures. Qualifications/Requirements: Basic Qualifications: - Bachelor's Degree in Pharmacy, Science, or an engineering discipline, OR equivalent knowledge and experience in Good Manufacturing Practices in the pharmaceutical industry - 5 years of Manufacturing/Quality experience in the Pharmaceutical sector - Familiarity with Quality Systems application in manufacturing, warehousing, and distribution Preferred Qualifications: - Experience working with multi-functional teams - Ability to work independently and prioritize tasks effectively - Strong communication skills, both oral and written - Excellent interpersonal skills to facilitate change and drive initiatives - Proficiency in problem identification and resolution If you possess the required skills and experience and are looking to contribute to a dynamic team focused on ensuring quality and compliance in GMP Manufacturing processes, we encourage you to apply for this role.,