35 Biologics Jobs - Page 2

Manager of Regulatory Affairs for Biologicals at Eris Lifesciences Ltd. in Ahmedabad will be responsible for ensuring regulatory compliance and facilitating the approval of biological products including loan license. This role offers an exciting opportunity for individuals with 9-10 years of experience in regulatory affairs within the biopharmaceutical industry. Key Responsibilities: 1. Regulatory Strategy Development: Collaborate with cross-functional teams to develop and execute regulatory strategies for biological products, ensuring alignment with corporate objectives and regulatory guidelines. 2. Regulatory Submissions: Prepare and submit regulatory documents, including CDSCO dossiers/queries, variations including scale-up changes, and annual reports, while ensuring accuracy, completeness, and timeliness. 3. Regulatory Intelligence: Monitor and interpret regulatory requirements, guidelines, and trends related to biological products to inform decision-making and maintain compliance. 4. Cross-functional Collaboration: Work closely with R&D, Clinical Development, Quality Assurance, and Manufacturing teams to support regulatory activities, resolve regulatory issues, and facilitate product development and registration. 5. Regulatory Compliance: Ensure compliance with applicable regulations and guidelines, including those set forth by regulatory authorities such as the CDSCO, FDA, EMA, and other global agencies, throughout the product lifecycle. 6. Regulatory Agency Interactions: Serve as a primary point of contact for regulatory agencies, participating in meetings, teleconferences, and regulatory inspections as needed to address inquiries and facilitate approvals. 7. Product Labelling and Promotional Material Review: Review and approve product labelling, promotional materials, and advertising to ensure compliance with regulatory requirements and company policies. 8. Regulatory Document Management: Maintain regulatory files and documentation in accordance with company procedures and regulatory standards, ensuring accessibility and traceability. 9. Risk Management: Identify potential regulatory risks and develop mitigation strategies to address them proactively, while fostering a culture of compliance within the organization. 10. Training and Development: Provide training and guidance to internal stakeholders on regulatory requirements, processes, and best practices to enhance regulatory compliance awareness and capabilities. Qualifications: Bachelor's or Master's degree in a relevant scientific discipline (e.g., biology, pharmacy, chemistry) or regulatory affairs. 9-10 years of experience in regulatory affairs or quality assurance within the biopharmaceutical industry, with specific experience in biological products preferred (rDNA). Strong knowledge of regulatory requirements and guidelines for biological products, including CDSCO, FDA, EMA, and other global regulations. Experience in preparing and submitting regulatory documents and interacting with regulatory agencies. Excellent communication, interpersonal, and problem-solving skills. Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities simultaneously. Proven ability to collaborate cross-functionally and influence stakeholders at all levels of the organization.

Onesource is looking for IPQA executive/ Sr Executives. Pls find the JD as below. Roles and Responsibilities Perform IPQA activities during formulation development, including batch manufacturing process validation. Conduct BMR reviews for injectable products, ensuring compliance with regulatory requirements. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Maintain accurate records of all QA activities, reports, and documentation.

Job Description Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 1-12 years above in production, preferably in the Bio-Pharmaceutical industry, specifically in vaccine manufacturing Educational Qualification: MSc Microbiology/Biotechnology/B. Pharm/B.Tech with more than 8 years of experience in vaccine biologicals and injectables Job Title: Senior Manager / Manager / Executive- Production Job Summary: The Senior Manager /Executive - Production will oversee daily vaccine manufacturing operations, ensure compliance with regulatory guidelines, manage production staff, and drive continuous improvement to enhance operational efficiency and product quality within the pharmaceutical industry. Key Responsibilities: Production Planning and Coordination: Plan, coordinate, and optimize end-to-end vaccine production activities to meet quality standards, timelines, and cost targets while ensuring resource availability. Oversee Manufacturing Operations: Supervise day-to-day manufacturing operations, including formulation, filling, packaging, and storage processes, ensuring efficient workflow and compliance with production protocols. Compliance: Ensure adherence to Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), and regulatory guidelines (FDA, EMA, WHO). Issue Resolution: Troubleshoot and resolve production-related issues to minimize downtime and ensure batch integrity. Team Management: Lead and manage production staff, providing training on safety, quality, and operational protocols specific to vaccine manufacturing. Performance Monitoring: Track key production metrics, implement strategies to improve batch yields, and reduce material wastage. Safety Enforcement: Enforce workplace safety protocols to prevent accidents, contamination, and ensure bio-safety compliance. Risk Management: Identify risks in production processes, such as contamination risks or equipment failures, and develop contingency plans. Material Handling: Ensure safe handling, storage, and disposal of biological materials, vaccines, and hazardous chemicals following industry best practices. Process Improvement: Drive continuous improvement initiatives to enhance production efficiency and product quality. Equipment Management: Oversee the maintenance, calibration, and validation of production equipment to ensure optimal performance. Documentation and Reporting: Ensure accurate documentation of production activities and prepare reports for regulatory compliance and internal audits. Skills and Competencies: Strong leadership and team management abilities in vaccine manufacturing environments In-depth knowledge of GMP, regulatory compliance, and vaccine production protocols Proficient in production planning, batch processing, and process optimization Excellent problem-solving and troubleshooting skills within pharmaceutical production settings Strong communication and interpersonal skills for effective team coordination Risk assessment and mitigation capabilities specific to biological production Commitment to bio-safety, product quality, and continuous improvement About GreenSignal Bio Pharma Pvt Ltd: GreenSignal Bio Pharma Pvt Ltd is a leading pharmaceutical company dedicated to delivering quality healthcare solutions, with a strong focus on vaccine manufacturing and biological products. Our commitment to innovation, compliance, and operational excellence drives our success. For more information, please visit our website: www.gsbpl.com How to Apply: Interested candidates can apply at: hr@gsbpl.com Contact us at: 8778926365 Apply Now to join our team and contribute to impactful pharmaceutical and vaccine innovations!

Dear all, Hiring for operators....... Location: Perundurai Qualification:ITI,DIPLOMA,DEGREE,12TH Job role: ETP Operations MBR Operations Biological Systems RO operations Zero Liquid Discharge Plant Evaporator Operations Scada operator Field operator Exp - 2-8 Years Working Hours - 8 hours in 3 shifts. (Rotational Shifts) No Food No Transport Salary - 2.5 LPA - 4 LPA interested candidate can send resume @m.venkatesh@manpower.co.in regards, Venkatesh.M Manpower Group

Position Upstream Scientist , Role Description As an Upstream Scientist , you will be responsible for planning and execution of experiments, analyzing data and preparing reports. Your contribution will be critical in advancing our vaccine programs. Candidate must be able to Design and execute process development studies to develop a thorough understanding of operating and performance parameters Perform hands on work in a cell culture lab, specifically cell culture expansion (insect as well as mammalian systems, adherent/ suspension), cell bank preparation, bioreactor operation in fed-batch and perfusion modes, optimization of media components, feeding control strategy Lead activities of vaccine production as well as process scale up with proper method development reports. Perform and analyse Design of Experiment (DOE) studies to develop or optimize processes to ensure a phase-appropriate, consistent, high-yielding and scalable upstream process from shake-flask to 200L scale bioreactor. Support in PPQ activities and scale-down model establishment, Support process characterization studies and tech transfer process. As needed, support process validation, including validation protocol writing, execution and report writing. Ability to think critically, demonstrate troubleshooting and problem-solving skills. Communicate with internal and external stakeholders through meetings and clearly written emails, reports, and presentations. Identify and leverage external capabilities that complement internal core competencies. Review and apply learnings from academic literature, patent filings and public domain information, to long and short-term in-house process development, on an ongoing basis Contribute to our intellectual property portfolio Contribute to Company-wide efforts to promote a safe work environment. Qualifications PhD with 3-8 years or Masters degree with 10-12 years in an industrial upstream process development role. Previous experience with fermentation matrices is strongly preferred. Should have experience handling various bioreactors, adherent and/or suspension cell cultures Knowledge of engineering principles related to scale-up of fermentation processes Culture process development experience such as cell passaging, formulation of media, aseptic technique processing, and managing reagents is a must Ability to thrive in a fast-paced environment Additional Considerations Previous experience in the following areas are all pluses: Working at a start-up or small company. Multi-year industrial fermentation experience with vaccines/biologics is preferred; direct experience with virus-derived recombinant products and/or viral particles is a plus. Familiarity with regulatory requirements for manufacturing vaccines. Authoring or contributing to SOPs. Managing junior engineers, research assistants, and technicians If interested and meet 80% of the criterion connect with us Intelli Search 9071129990 and email profiles@intellisearchonline.net

Function: Biologics Position: Regulatory Affairs- CMC Job Location: Govandi (East ), Mumbai (2nd & 4th Saturday off, 1st, 3rd and 5th Saturday working) Desired Qualification: M.Pharm/B.Pharm Desired Work Experience: 8-12 years Job Responsibilities: 1. Biosimilar Regulated market submissions - US / EU market submission 2. Biosimilar Product Development Strategy for CMC and Clinical 3. Review of all Dosisier related Quality documents inclusing coordination with Cross functional teams ( R&D, QC/QA and Manufacturing) 4. Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions 5. MOH Query response 6. Biosimilar Product Life Cycle Management 7. RA support for Plant related QMS activities

Candidate having 7-10 Years experience with any Science Graduate. Should be responsible for the Business Development, having experience in Pharma industry - Vaccines / Formulations / Poultry/ Veterinary / Human, having rapport with Government Departments as well as e-tendering. Roles & Responsibilities Meet with customers/clients face to face or Virtual. Develop relations with customers/ clients Liaise with the finance team, warehousing and logistics. Negotiations Sales forecasts and analysis and present your findings to senior management Sales and marketing strategy e-tendering and purchase procedure of State Govt / Co-operatives / Central Govt / Ministry

Desired Experience : 3-7 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Main purpose of the Job: Responsible for Preparation of Regulatory Documents for submission to Indian NRA, WHO and other Regulatory Authorities. Job Responsibilities: 1. Preparation of following Regulatory Submission Packages related to NRA submissions but not limited to. a. Application for Post Approval Change(s) b. Marketing Authorization Applications c. Clinical trial applications d. Support the submission of Import licenses/ export NoC e. Support the preparation, review and submission of applications/ response to RCGM vide IBSC f. Support in handling of SUGAM, IBKP, NSWS & ONDLS/ ODLS sites 2. Assisting in Responding Queries to various regulatory authorities. 3. Preparation of dossiers / submission packages for NRA submissions. 4. Preparation of dossiers for registration in ROW countries. 5. Maintenance of Documentation Data base available with RA. 6. Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution and Marketing. 7. Routine Interaction with QA-documentation for updating Master Files. 8. Review of Pack Profiles. 9. Review of Artworks (Labels and Package Insert). 10. Preparation / compilation of technical documents related to tenders / queries. 11. Arranging Samples required for registration. 12. Any other support required by the other members of RA. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for Department Name

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 client's organization goals. Must have skills : Oil and Gas Upstream Good to have skills : NA Minimum 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-service transformational opportunities. You will architect end-to-end integrated solutions leveraging the best mix of offerings, assets, and capabilities to maximize value for the client and Accenture. Your role will involve ensuring alignment of the solution to the client's organizational goals. This is a senior-level position in Solution Architecture with a focus on the Oil and Gas Upstream domain. Roles & Responsibilities: Expected to be a Subject Matter Expert (SME) with deep knowledge and experience in Oil and Gas Upstream. Should have influencing and advisory skills to guide and influence team decisions. Responsible for engaging with multiple teams and contributing to key decisions. Expected to provide solutions to problems that apply across multiple teams. Collaborate with stakeholders to understand business requirements and translate them into technical solutions. Lead the design and development of enterprise-level solutions that align with the client's business goals. Ensure the solution architecture is scalable, reliable, and secure. Provide technical guidance and mentorship to junior team members. Professional & Technical Skills: Must To Have Skills:Proficiency in Oil and Gas Upstream. Strong understanding of solution architecture principles and best practices. Experience in designing and implementing complex enterprise solutions. Knowledge of industry standards and trends in the Oil and Gas Upstream domain. Experience with cloud technologies and their application in solution architecture. Good To Have Skills:Experience with data analytics and visualization tools. Familiarity with Agile methodologies and DevOps practices. Excellent communication and presentation skills. Additional Information: The candidate should have a minimum of 15 years of experience in Oil and Gas Upstream. This position is based at our Bengaluru office. A 15 years full-time education is required. Qualifications 15 years full time education

1. Preparation and Maintenance of SOPs, STPS, Specifications, GTP's and Worksheets related to Product testing. 2. Preparation, revision, review and execution of Analytical method Validation protocols and reports related to product testing. 3. Operation and calibration of QC Instruments related to product testing. 4. Testing and release of product samples by techniques such as: General tests (Physical appearance, pH, Color, Extractable volume, Osmolality, Conductivity, etc.) Gel Electrophoresis (IEF, SDS-PAGE, etc.) Colorimetric assays (Sialic acid, Quantification of Polysorbate 80 and Polysorbate-20, etc.) Quantification assays (Protein concentration by absorbance (Spectral scan)/Protein content by UV (OD @ 280 nm, Trehalose dihydrate, Mannitol, Sucrose, etc.) ELISA's (Host Cell derived Proteins, Protein A Leachate, etc.) Q-PCR (Host Cell DNA, Mycoplasma testing etc.) HPLC techniques (Product concentration by RP-HPLC, Size Exclusion chromatography, Peptide mapping, etc.) UPLC techniques (Cation exchange chromatography, Protein A Chromatography. N-Linked Glycans by hydrophilic liquid interaction chromatography, etc.) Capillary electrophoresis. 5. Preparation of reagent solutions, buffers and maintenance of the records. 6. Sample receiving, A.R.No allotment, Testing, Documentation and reporting of analytical results and Review in LIMS for In-process, batch release, stability and Miscellaneous samples related to product testing. 7. Withdrawal and aliquoting of batch release and stability samples for analysis. 8. Temperature and humidity monitoring of labs and instruments. 9. Responsible for CGLP compliance. 10. Responsible for handling of OOT (Out Of Trend), OOS (Out Of Specification), Incidents, LIRs and Change controls related to product testing. 11. Maintenance of stability samples and reserve samples related to product testing.