93 Biologics Jobs

IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws The Manager, Regulatory Affairs CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage form including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or both

About the Company Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming...

About Immuneel Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer www.immuneel.com 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 startup on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in experience and ...

Summary Job Functions: Accountability of project deliverables Key Responsibilities: 1. Act as an anchor point for the project/program and ensure tracking and timely task completion 2. Collaboratively drive execution of projects in partnership with Project Leaders and SMEs from quality, manufacturing, clinical etc. 3. Help ensure that critical decisions are taken in a structured and timely manner with input from appropriate stakeholders. 4. Ensure that critical activities are successfully performed in a timely manner 5. Identify potential resource constraints and propose mitigations 6. Proactively work with R&D, manufacturing to address project requirement 7. Identify critical path activities...

As the Senior Product Manager, Biologics at the U.S. Pharmacopeial Convention (USP) in India, you will play a crucial role in managing the existing Biologics portfolio of Reference Standards and Analytical Reference materials. Your responsibilities will include contributing to enhancing the global quality and supply of Biologics Drugs in collaboration with various stakeholders such as biopharmaceutical developers, manufacturers, and regulatory agencies. You will oversee the lifecycle management of current USP standards, ensuring they address the needs and challenges faced by developers and manufacturers in different therapeutic areas. Collaborating with cross-functional teams, you will be in...

We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. Key Responsibilities: Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets. Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATAM, a...

We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. Key Responsibilities: • Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets. • Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATA...

PharmaACE is a growing Global Healthcare Consulting Firm, headquartered in Princeton, New Jersey. Our expert teams of Business Analysts, based across the US, Canada, Europe, and India, provide Analytics and Business Solutions using our worldwide delivery models for a wide range of clients. Our clients include established, multinational BioPharma leaders and innovators, as well as entrepreneurial firms on the cutting edge of science. We have deep expertise in Forecasting, Business Analytics, Competitive Intelligence, Sales Analytics, and the Analytics Center of Excellence Model. Our wealth of therapeutic area experience cuts across Oncology, Immuno-science, CNS, CV-Met, and Rare Diseases. We ...

The Regulatory Compliance Team Lead will be responsible for overseeing a team of regulatory CMC professionals performing assessment of operational changes for regulatory reportability for Amgen products across phases of development, modality, and countries. This role is accountable for hiring, training and retaining talented regulatory CMC regulatory staff, in alignment with the operational objectives of the wider RA CMC department. They are accountable for continuous improvement, through the development and refinement of processes, and partnership with colleagues in other functions to develop systems and tools that improve the speed and efficiency of operations over time. They exemplify the...

Project Role : Enterprise Solution Architect Project Role Description : Lead the development of complex solutions across multi-tower and/or multi- service transformational opportunities. Architect end-to-end integrated solutions leveraging the best mix of offerings, assets, and capabilities to maximize value for the client and Accenture. Ensure alignment of solution to clients organization goals. Must have skills : Oil and Gas Upstream Good to have skills : NAMinimum 15 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Enterprise Solution Architect, you will lead the development of complex solutions across multi-tower and/or multi-servi...

As a Scientist - Research & Development (Downstream Process Development) at Immuneel, you will be responsible for leading the downstream process development for viral vectors. Your key deliverables will include driving projects through process development towards global IND applications. You should have a strong understanding of filtration, concentration, and chromatography processes, along with experience in Biologics with brief exposure to Viral Vectors. Your primary objectives will involve upstream process development for viral vectors, technology transfer of upstream processes, and associated documentation. You will also be responsible for coordination with CMO/CDMO for the supply of res...

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,...

PharmaACE is a rapidly growing Global Healthcare Consulting Firm with its headquarters in Princeton, New Jersey. Our team of skilled Business Analysts, located in the US, Canada, Europe, and India, specializes in providing Analytics and Business Solutions through our global delivery models to a diverse clientele. We cater to established multinational BioPharma leaders, innovative companies, and cutting-edge entrepreneurial firms. With expertise in Forecasting, Business Analytics, Competitive Intelligence, Sales Analytics, and the Analytics Centre of Excellence Model, we cover a wide range of therapeutic areas including Oncology, Immuno-science, CNS, CV-Met, and Rare Diseases. Our services ex...

As a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations), your main responsibility will be to develop and execute global regulatory strategies for combination product devices. You will play a crucial role in ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. To excel in this role, you should have a minimum of 5 years of regulatory affairs experience in biosimilars, biologics, or combination product development. Your expertise will be instrumental in providing regulatory guidance on device design, human factors, risk management, and manufa...

Primary Responsibilities: Sales & Revenue Responsible for regional sales & Revenue targets. Achieving revenue targets and KPIs. Business Development. Identify and pursue new business opportunities (Leads / Enquiries) Conduct market research to understand regional trends, customer needs, and competitive landscape. Build and maintain strong relationships with prospective and existing clients. Serve as the primary point of contact for regional clients, ensuring high levels of satisfaction and experience. Conduct client meetings, presentations, and site visits to promote services. Prepare compelling proposals/quotations, client submission, negotiation and securing projects. Sales Performance & R...

2-3 years experience in a laboratory function or business development in technical or related industry. Tertiary qualifications (science, business or related) Develop overall business development and customer relations strategy for the assigned accounts resulting in the achievement of the sales target. Job Profile: Identify the lead, nurture and convert the lead. •Conduct market research to understand regional trends, customer needs, and competitive landscape. •Build and maintain strong relationships with prospective and existing clients. •Serve as the primary point of contact for regional clients, ensuring high levels of satisfaction and experience. •Conduct client meetings, presentations, ...

IMEA (India, Middle East, Africa) India LIXIL INDIA PVT LTD Employee Assignment Hybrid Full Time 12 July 2025 The Job Description Is Mentioned Below, Job title Area Sales Manager Base location Responsibilities- Dealer network sales-managing & appointing new sub-dealers in a given territory by completing all formalities, Regularly meeting and developing relationships with Architects, Builders, interior designers, etc to generate inquiries and close sales, Achievement of targeted sales volumes through Retail & Distribution Sales Procurement of orders from dealers and timely supply thereon, Work in coordination with the marketing team for proper and timely display, Conducting Architect & plumbe...

Role & responsibilities: The candidate should be an expert in the area of drug product development. He/she should have high level of experience to be called a subject matter expert in concepts of product stability, role of excipients in protein stability, knowledge of higher order structure and its role on product stability The candidate should be well-versed on drug product formulation development. He/she should have knowledge on the concepts of developing a brand new formulation, evaluation of buffer systems, sugar excipients, role of surfactants such as polyols etc. Having experience of developing new formulations for Biosimilar products is a plus The candidate should have experience in r...

PharmaACE is a growing Global Healthcare Consulting Firm, headquartered in Princeton, New Jersey. Our expert teams of Business Analysts, based across the US, Canada, Europe, and India, provide Analytics and Business Solutions using our worldwide delivery models for a wide range of clients. Our clients include established, multinational BioPharma leaders and innovators, as well as entrepreneurial firms on the cutting edge of science. We have deep expertise in Forecasting, Business Analytics, Competitive Intelligence, Sales Analytics, and the Analytics Center of Excellence Model. Our wealth of therapeutic area experience cuts across Oncology, Immuno-science, CNS, CV-Met, and Rare Diseases. We ...

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. They prioritize equal employment opportunity and base their employment decisions on merit, considering qualifications, skills, performance, and achievements. The company aims to ensure that all applicants and employees receive equal opportunities in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions. They also provide reasonab...

The Opportunity: To Sell entire Biopharma product portfolio, with emphasis on Small Molecule Market. Close sales on more technical products, working in conjunction with internal functions, Identify and ensuring the process of converting sales opportunities for relevant products from Avantor Biopharma offerings. What we are looking for : Experience: 7-8 years of Biopharma Pharma Life science - Sales industry experience required. Education: BS degree in a life science area, or equivalent work experience required. Identify and close new biopharma business. Meeting the budgets for both top and bottom line, ensuring growth in sales figures along with market share by virtue of careful product posi...

Greetings from Kashiv Biosciences!!! We are looking for Upstream Process Development Specialist( MSAT) for our Biosimilar manufacturing facility( R&D Center) based out of Ahmedabad. Following are the Roles and Responsibilities Roles & Responsibilities Responsible for Upstream Process Development for Mammalian Cell culture. Responsible for Scale Up from Pilot study to Bulk Manufacturing. Technology Transfer from R & D to Manufacturing . Qualification and validation of equipment. Exposure to Perfusion process and technique is must. CHO clone development, Clone screening, Shake flask studies, media optimization and bioreactor process development. Candidate Details The Candidate should be a Ph.D...

Job Duties and Scope: Sales & Revenue Growth - Achieve or exceed regional sales targets and KPIs. - Prepare and deliver proposals, quotations, and contract negotiations. - Track and report on sales pipeline, forecasts, and performance metrics . Sales Performance & Reporting - Prepare and present weekly, monthly, and quarterly sales reports - Develop and maintain dashboard presentations for internal reviews and leadership meetings. - Analyse sales data to identify trends, gaps, and opportunities for improvement. Client Relationship Management - Build and maintain strong relationships with key clients, prospects, and industry stakeholders. - Serve as the primary point of contact for regional c...

JOB DESCRIPTION We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. RESPONSIBILITIES: • Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements • Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained pe...

ROLE DESCRIPTION: We are looking for a dynamic and experienced Site Head Injectable Manufacturing to oversee our manufacturing site dedicated to producing high-quality injectable products. The successful candidate will lead the operations, ensure regulatory compliance, and drive process improvements within the site. This role requires a strategic thinker with a proven ability to lead cross-functional teams and ensure that production meets the highest standards of quality, efficiency, and safety. Key Responsibilities: Leadership & Strategy: Lead all operations of the injectable manufacturing site, developing and implementing strategies to meet the organization's goals. Ensure the site is oper...