162 Biologics Jobs

Key Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation strategies during planning and execution. 2. Dossier Preparation & Submission • Oversee the preparation, review, and submission of high-quality dossiers (CTD/eCTD format) for new marketing authorizations, renewals, and variations. • Coordinate with CMC, non-clinical, clinical, and labeling teams to gather required documentation. • Ensure submission tim...

- Develop & Execute regulatory strategies - Stay updated on evolving global regulatory requirements & ensure products comply with international standards - Collaboration with Cross functional teams including R&D, QA, Clinical developments. Required Candidate profile - Strong leadership & management skills, including experience leading cross functional teams - Proven track record of successful regulatory submissions & approvals

Role Overview: PharmaACE is a growing Global Healthcare Consulting Firm, headquartered in Princeton, New Jersey, with expert teams of Business Analysts across various locations. The firm provides Analytics and Business Solutions to a diverse clientele in the BioPharma sector, with expertise in Forecasting, Business Analytics, Competitive Intelligence, and more. They cater to clients in different therapeutic areas such as Oncology, Immuno-science, CNS, CV-Met, and Rare Diseases, across Primary Care, Specialty Care, and Hospital business units. Key Responsibilities: - Analyze different pharmaceutical/life sciences data sets including claims data, electronic medical records, patient level data,...

Role & responsibilities: 1. Lead investigations into quality incidents, deviations, and non-conformances within our manufacturing processes. 2. Conduct thorough root cause analyses to identify the underlying causes of quality issues and develop effective corrective and preventive actions (CAPAs). 3. Collaborate closely with cross-functional teams, including production, engineering, and quality control, to drive investigations to resolution. 4. Utilize scientific and statistical methodologies to support investigations and determine appropriate corrective actions. 5. Provide technical expertise and guidance to junior investigators and ensure investigations are conducted in compliance with regu...

Job Title - Asst Manager / Manager Department - Business Development - BioPharma Services. Location - Bangalore / Mumbai/ Ahmedabad About ALS India ALS is a global leader in testing, inspection, certification & verification, present in 65+ countries with 350+ labs. ALS India offers cutting-edge analytical services across Pharmaceutical, Food, Environment & Consumer Products from a 30,000 sq. ft. facility in Bengaluru. Qualification Bachelors or master’s in chemistry, Pharmaceutical Sciences, Biochemistry, or related life sciences field. MBA or equivalent business qualification optional. Experience Minimum 5-8 years of experience in business development or key account management within the ph...

Role Overview: PharmaACE is a growing Global Healthcare Consulting Firm based in Princeton, New Jersey. With teams of Business Analysts located in the US, Canada, Europe, and India, we provide Analytics and Business Solutions to a diverse clientele in the BioPharma industry. Our expertise spans across Forecasting, Business Analytics, Competitive Intelligence, Sales Analytics, and more, covering therapeutic areas like Oncology, Immuno-science, CNS, CV-Met, and Rare Diseases. Key Responsibilities: - Demonstrate a strong understanding of diseases, drugs, and clinical trial data - Evaluate companies and their assets, including pipeline and marketed products - Conduct pipeline and competitive lan...

Role Overview: PharmaACE is a growing Global Healthcare Consulting Firm with expert teams of Business Analysts providing Analytics and Business Solutions for a wide range of clients in the pharmaceutical industry. As a Global HR Lead based in Pune, you will be responsible for leading the HR department, developing and executing HR strategies aligned with business goals globally, ensuring compliance with labor laws, advising executive leadership, analyzing HR metrics, and fostering a positive work culture. You will work closely with the Leadership Team to drive HR functions in India and across global locations. Key Responsibilities: - Develop and implement comprehensive HR strategies aligned w...

Dear Candidate , we are hiring for Fresher for the position Microbiologist . Job Description: Department:- Microbiology Exp: 2.0 yrs to 3.0 yrs Des:- Jr Executive-Executive Qua:-MSc Microbiology Only Male Candidates Preferable Bio burden testing of in process samples as per the specification. BET testing of water samples, in-process samples, semi-finished and finished samples as per the specification. Sterility testing of finished product. Responsible to perform the MLT testing for raw materials and water samples. Maintenance and handling of Endotoxin indicators and biological indicators. Experience on culture maintenance and VITEK2 compact system To perform the method validations for MLT, B...

DEAR CANDIDATE , WE ARE HIRING! LET'S JOIN OUR TEAM NOW! Department: R&D Position: Research Trainee / Research Associate Preferred Qualification: M.Sc. Biotechnology / M.Sc. Biochemistry Preferred candidate: Male Preferred Experience: 2 to 3 years of experience Should have good documentation skills and knowledge of GDP, GMP, GLP. Should have basic knowledge about proteins and protein purification. Should be a good team player with good interpersonal skills. Job description: Perform R&D related documentation like SOP preparation, data management and data analysis. Perform routine laboratory procedures, including buffer preparation, gel electrophoresis, western blot. Operation and maintenance ...

Dear Candidate , we are hiring for QC Jr Executive ,Down stream process executives & Operators. Open Positions-50 Down Stream Process Executives & Operators Required • Qualification: Bsc/Msc/ITI/B Pharmacy Experience in handling the following Equipment 1 Chromatography column and system handling. 2 Column Packing (BPG And Chromoflow) 3 TFF System 4 Centrifuge system 5 Filtration, Filter Integrity,Buffer Preparation,CIP_SIP PRODUCTION-DS M Pharmacy/Diploma/B tech/Any Degree 6 Expertise in documentation QMS/GMP Compliance / Process Awareness Biologics Company's only Preferable. • Experience: 2 to 6 years in Total Downstream CTC :up to 5.0 LPA. IMMEDIATE JOINERS ARE PREFERABLE" Interested candi...

Dear Candidate , we are hiring for the Position Jr Executive .(Instrumentation,Hematology,Activity,Potency Based Assays,Bio chemical group) 1.Candidate have good hands on experience in HPLC, electroscopic test methods. 2.should be able to handle liquid chromatography instrument and relevant 21 CFR softwares 3.should be able to handle ELISA Reader ,microscope,basic QC Instruments . 4.candidate should have good hands experience in colorimetric ,spectrophotometric. 5. should be have a idea on GLP compliance requirements. for more details please reach out Venkat -9381915043 /Manasa - 9502434725

Dear Candidate , we are hiring for the Position Jr Executive .(Instrumentation,Hematology,Activity,Potency Based Assays,Bio chemical group) 1.Candidate have good hands on experience in HPLC, electroscopic test methods. 2.should be able to handle liquid chromatography instrument and relevant 21 CFR softwares 3.should be able to handle ELISA Reader ,microscope,basic QC Instruments . 4.candidate should have good hands experience in colorimetric ,spectrophotometric. 5. should be have a idea on GLP compliance requirements. for more details please reach out Venkat -9381915043 /Manasa - 9502434725

Job Description: 1 . Hands on Experience in regulatory submissions preferably for Blood products and Biologics. 2. Review/Submission of applications for new products Manufacturing licenses and renewals. 3. Experience on procedures for application of new drugs (NOC's and Test licenses). 4. Monitoring and ensuring allp certificates (COPPs, GMP, GLP, WHO-GMP and FSC Production Capacity and Performance Certificate) renewals and approvals up to date. 5. Review of Tender certificate. 6. Co-ordinate with Drug control authority personnel for License approvals. 7. Review of Dossiers. 8. Submission of Samples and Documents to NIB, Noida for testing. 9. Updation of the National and international legisl...

Dear Candidate, WE ARE HIRING Department: - Production- DS Designation: - Dy Manager / Manager Qualification: - Preferably Post Graduation in Science Experience: - 15+ Years Age: - Between 35- 40Years Mandatory: - Should come in all shifts, including Night shifts Role: Shift-in-charge for entire DS floor Job Description: > Strong Functional knowledge of DS Biologics (Chromatography and related purification experience protein/ Insulin handling experience preferable). Capable of handling large teams as we have around 45 members in each shift, around 50% of contractual staff. Strong administration / team management capabilities to streamline GMP across the floor. Monitoring the efficiency of em...

Job Title: Principal Scientist / GM BioAg Location: Gurgaon The Role We are seeking a visionary scientific leader to head our Bio Agri-inputs team. This is a high-impact leadership role within the Xenesis leadership team, responsible for driving the strategy, execution, and commercialization of our next-generation biological agri-inputs portfolio. You will own the end-to-end product pipeline for development and commercialization of products focused on improving soil health, plant nutrition and crop protection. The role will include the following: 1. Leadership & Strategic Planning Develop and drive a strategic vision for the BioAgri portfolio aligned with business goals and customer needs. L...

Role & responsibilities Perform Mass Spectrometry (LC-MS/MS) analysis for structural and physio-chemical characterization of peptides/proteins (Intact mass, Peptide mapping, Sequencing) Operate and maintain high-resolution mass spectrometer (Q-TOF/Orbitrap/Relevant Instruments) Support characterization studies for biologics - Insulin and Insulin Analogues, Therapeutic proteins and Biosimilars Ensure proper compliance in line with GLP norms Preferred candidate profile Proficient in advanced proteomic analysis methods. Proficient in impurity analysis, top-down and bottom up proteomics Experience of using various advanced structural characterization methods (CE, CD, DSC, DLS, IR, AUC) would be ...

Regulatory Affairs Job Opportunity! Desired Experience : 5- 11 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Senior Executive/ Assistant Manager Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Job Responsibilities: Responsible for Preparation of Regulatory Documents for submission to Indian Regulatory Authorities. Experienced in handling, management and expansion of product portfolios, markets/ territories. Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC. Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC,...

Walk-In for Blending, Filling, Packing, Labelling (BFPL Production), Educational Qualification: M.Sc/ B.Sc/ B. Pharmacy/ Diploma (Any Life Sciences background) Experience: 2-10 years Department: Blending, Filling, Packing, Labelling (BFPL Production), Work Location: Biological E. Limited (Vaccine Division), Kolthur, Hyderabad Desired Experience: Applicants with relevant experience in vaccine, biosimilars, or injectable manufacturing will be considered. Roles & Responsibilities: PRODUCTION FORMULATIONS (INJECTABLES) BLENDING: Ability to manage shift plans for formulation activities. Operate and maintain equipment such as autoclaves and blending vessels, CIP and SIP skids FILLING: Ability to m...

As a Global Healthcare Consulting Firm, PharmaACE is dedicated to providing Analytics and Business Solutions to a diverse range of clients in the pharmaceutical and life sciences industry. We are seeking a talented individual to join our team in the role of a Business Analyst. **Key Responsibilities:** - Analyze various pharmaceutical and life sciences data sets such as claims data, electronic medical records, patient level data, prescription data, and sales data - Communicate findings to clients and collaborate with onshore team members - Develop and nurture client relationships while acting as a key offshore contact for projects - Understand business objectives and create models to support...

Role & responsibilities Responsible for upstream manufacturing process support, data acquisition, and trending. To manage statistical analysis of manufacturing batches data using statistical software like Minitab, etc. Lead the upstream team in troubleshooting and process related deviation investigations activities to identify the root cause followed by providing an effective CAPA. Plan, evaluate and manage the technology transfer of new / existing products from sending unit (R&D) to receiving unit (Manufacturing). To collaborate and communicate regularly with R&D teams in execution of experimental runs and any other scale down experiments to support manufacturing process changes/improvement...

Walk-In for Blending, Filling, Packing, Labelling (BFPL Production), Antigen Manufacturing, & Engineering Departments. Educational Qualification: M.Sc/ B.Sc/ B. Pharmacy/ Diploma (Any Life Sciences background) Experience: 2-10 years Department: Blending, Filling, Packing, Labelling (BFPL Production), Antigen Manufacturing, & Engineering Designation: Assistant Manager/ Sr. Executive/ Executive/ Sr. Officer/ Officer Location: Biological E. Limited (Vaccine Division), Kolthur, Hyderabad Desired Experience: Applicants with relevant experience in vaccine, biosimilars, or injectable manufacturing will be considered. Roles & Responsibilities: PRODUCTION BULK MANUFACTURING (DRUG SUBSTANCE / ANTIGENS...

Job Summary: We are hiring Business Development Managers to drive sales growth and adoption of our Biologics portfolio across multiple regions in India. Locations: Hyderabad, Bengaluru, Chennai, Pune, Ahmedabad, Mumbai, Delhi NCR, Kolkata, Chandigarh. Key Responsibilities: - Achieve sales and revenue targets for the assigned territory/region. - Identify, engage, and develop new customers (surgeons, hospitals, sports medicine centers). - Build strong relationships with KOLs, decision-makers, and procurement teams. - Drive adoption through product presentations, demos, and surgeon engagement. - Collaborate with Clinical Specialists for OT case support and workshops. - Work with Marketing team ...

Position: Principal/Senior Principal Scientist Location: Mysore, Karnataka Experience: 8 to15 years About Us: Vipragen Biosciences Pvt ltd is a leading organization specializing in drug discovery and development services. We are committed to advancing scientific research and innovation through cutting-edge technology and a collaborative work environment. Industry: Preclinical CRO (GLP-OECD certified) About the Role: Vipragen Bioscience Pvt Ltd is seeking an experienced and highly accomplished Principal Scientist Cell Biology & Pharmacology to join our dynamic team at our OECD GLP-certified preclinical CRO in Mysore. The ideal candidate will bring deep expertise in cell biology, in vivo pharm...

1. Review of Biotech R&D Documents as per ALCOA++ requirements, metadata review, and data integrity checks. 2. Review of Process Development Reports, Tech transfer documents, Process Characterization Reports. Co-ordination from DOA end to support for Tech transfer activities. Review of Clone Development, Clone Characterization and Packaging Documents. 3. QAMS review support for evaluation and approval of Quality Management notifications such as deviation, Change Control, CAPA and LIR. 4. QAMS Management: Tracking of QAMS Notifications, co-ordination with R&D for QAMS related activities, Periodic Review and Trending as per SOP and troubleshooting of QAMS system . 5. Co-ordination with CQA and...

Job Summary: Responsible for supporting and leading process development and scale-up activities for recombinant therapeutic proteins. Plays a key role in executing upstream operations, managing project timelines, contributing to regulatory submissions, and ensuring compliance with quality and data integrity standards. Collaborates cross-functionally to ensure successful manufacturing of toxicology and clinical batches. Support end-to-end development and execution of upstream processes for recombinant therapeutic proteins. Act as project lead for select molecules under guidance, coordinating with cross-functional teams. Perform small to pilot-scale fermentation or cell culture experiments for...