Role & responsibilities : Person would be team leader. Person would be responsible for managing 6-10 people from sr. scientist to interns. Candidate would be responsible for planning of work for direct reportees, reviewing of their timesheets. Candidate would be responsible for coordination with cross functional team and AAT team. Person would be responsible for representing AAT in internal meetings Person should be experienced for HPLC, CE, SoloVPE related techniques, trouble shooting , data review and data interpretation Knowledge in characterization methods such as Mass analysis, CD, Flr, DSC, MALS would be an additional advantage. Person should know method qualification for HPLC, CE, SoloVPE related techniques Person would be involved in document preparation and review of MQP, MOA, MQR, Specification, analytical similairty studies Experience in analytical section related sourced document preparation for EMA and USFDA would be an additional advantage Person would be responsible for preparaing client query response and timely communication to cross functional team Technical Skill Requirement: Knowledge for HPLC based methods such as SE HPLC, CEX HPLC, Poly 20 measurement, RP HPLC, Capillary Electrophoresis related based techniques such as CE SDS R & NR, cIEF. CE analysis on Maurice system would be an added advantage SoloVPE analysis Soft Skill Requirement: Fluent in English, Should be approachable Able to present technical data in internal meeting Able to faciliate required work by coordinating with cross funcational team Technical review of the the data and ensuring timely communication to cross funcational team Able to resolve/disucss with manager if any conflicts within team is oberved
Role & responsibilities 1.Responsible for work planning and review of documents related to In process, DS, DP, stability testing, AMV and AMT activities within quality control laboratory. 2. To effectively plan and monitor shift duties of the QC analytical staff members to support 24*7 business operations. 3. Responsible for compliance to internal, external & statutory compliances as per quality policy of Enzene, pharmacopoeia guidelines and other regulated guidelines. 4. Responsible for periodic training management related to quality, GMP, regulatory aspects to quality control laboratory personnels and evaluation of effectiveness. 5. Responsible for the periodic assessments/audits to identify gaps / improvement opportunities for strengthening the quality & regulatory compliance. Prepare remediation/mitigation plan (CAPA) and execute it in a timely manner by coordinating cross functionally to uplift the level of compliance’s. 6. Responsible for review and approval of documentation such as SOP’s, Specifications, STP’s, TDS, reports for IRS analyst qualification, protocols, Qualifications and reports etc. 7. Responsible for investigations and approval of OOS, OOT and deviations. To recommend and approve CAPA, change controls. 8. To release or reject the samples handled in quality control laboratory.
Role & responsibilities • Design and execute media/feed screenings and optimizations using ambr250 and bioreactor culture • development, including fed batch and perfusion cell culture processes. • Planning, assigning, and supervising daily operations to ensure proper experiment execution • Experience with aseptic techniques, cell culture in various lab-scale formats, small to medium scale • bioreactors, and cell counting methods and equipments like Cedex, Vi Cell, Osmometer • Handling of Mammalian cell culture using bench top, single use bioreactor and high throughput • systems such as ambr250, WAVE bioreactors and ATF systems. • Excellence in cell culture process development by Fed batch as well as Perfusion process. • Bioreactor culture development including fed-batch, N-stage perfusion technologies (2 to 50L scale) • with both glass and single-use cell culture technologies • Daily review of ongoing experimental data • Reviewing functional PDR, TTD etc. • Good interpersonal, verbal and written communication skills. • Excellent communication and presentation skills and aptitude for problem solving • Act as an effective and committed team player Experience & Qualification:- 1. 9 to 15 years of experience with M.Tech/M.Sc. degree in biotechnology/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline. 2. Ability to work and collaborate in cross functional teams, research, development, manufacturing in a fast pace and dynamic team setting.
Job Description: Planning and execution of Downstream Process activities for mammalian and/or microbial products/recombinant protein under the supervision of the manager. Responsible for ground level planning, execution, data capturing, compilation, and interpretation in coordination with the Associate scientist/Scientist. Drafting of presentation and discussion with the manager. Presenting data in internal meetings as functional lead. Responsible for documentation activities like preparation of development reports, BPR, SOP, EOP, IOP. Participate in planning and decision-making discussions regarding activity priorities, providing information on the feasibility of prospective projects to the reporting manager. Supporting in troubleshooting of technical problems at manufacturing by discussion and execution. Candidate will be responsible for lab management activities (Maintaining lab cleanliness, equipment maintenance). Cross-functional communication with internal and external vendors/clients for technical queries in consultation with the manager. The candidate will be responsible for maintaining environment, health, and safety (EHS) requirements at the workplace to ensure individual and lab/plant safety. Technical Skill Requirement: Protein purification process development expertise (Chromatography, Depth filtration, Centrifugation, UFDF, sterile filtration, etc.) in mammalian/microbial expressed antibodies and/or therapeutic proteins. Execution and monitoring of processes to ensure consistency and reliability. Awareness about Process Development using DoE approach and Quality by Design (QbD) will have added advantage. Scale up/Down, technology transfer activities. Responsible for setup, operation, troubleshooting, and routine maintenance of purification equipment (Chromatography system, pH/conductivity meter, UFDF system, etc.). Strong commitment and dedication towards work, enthusiasm, motivation, and persuasive ability in a team. Work independently, analyze and interpret experimental data, and present/document experimental results at meetings. Proficiency or awareness in protein analytical techniques (e.g., protein assay, gel electrophoresis, HPLC, etc.) is an added advantage. Willingness to work in a dynamic environment with a stringent timeline. Soft Skill Requirement: Strong written and communication skills. Team player.
Regulatory Affairs Management- Understands the regulatory framework, including regional trends, for various types of applications and procedures for biological therapeutic products (Biologics, Biosimilar, Novel Biologics and Vaccines) in India and ROW markets. Provides regulatory input on procedural and documentation requirements as defined by Health Authorities such as Indian regulatory authority, Emerging markets and ROW countries. Review of documents (e.g. RCGM-PCS, CTA, MAA, PAC, response documents, study protocols, regulatory maintenance documents, PSURs, etc.). Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product. Uses and shares best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment. Leads and / or contributes to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions. Liaises closely with cross-functional members with aligned product responsibilities. Develops, completes and maintains submission delivery plans, submission content plans, and proactively provides status updates of the ongoing projects within the organization. Coordinates the input, maintenance and revision in the project planning tools for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to function head. Supports operational team and Project team w.r.t to regulatory requirements. Provides coaching, mentoring and knowledge sharing within the team. Contributes to process improvement. Minimum Requirements Education and Experience Relevant University Degree in Science or related field Minimum 10-16 years of relevant Regulatory experience within the biopharmaceutical industry, including experience in CTA, MAA, PAC and ROW markets for Biological and Biosimilar products and general knowledge of drug development Good knowledge of the regulatory product maintenance process Strong project management skills Leadership skills, including experience leading multi-disciplinary project teams. Preferred Experience Regulatory affairs experience across a broad range of markets. Having experience in Regulatory information management system Handled regulatory deliverables at the project level Experience of working with people from locations outside of India, for Emerging and ROW markets. Skills and Capabilities Excellent English written and verbal communication skills Cultural awareness Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions Proficiency with common project management (e.g., MS Project) and document management tools Ability to work independently and as part of a team Influencing and collaborator management skills Ability to analyse problems and recommend actions Continuous Improvement and knowledge sharing focused Operations/Manufacturing organisation (CMC post approval) Marketing Companies/Local affiliates Reporting Relationship Direct Reports – 2-4
Role & responsibilities Serve as the primary subject matter expert for all bioanalytical methods, including method development, validation, and sample analysis. Design and execute complex experiments for the quantification of drug candidates, metabolites, and biomarkers in biological matrices using a variety of platforms (e.g., Ligand Binding Assays, cell-based functional assays). Lead the evaluation, implementation, and troubleshooting of new analytical platforms and technologies to advance the laboratory's capabilities. Develop and influence bioanalytical strategies for multiple projects across the drug development pipeline. Manage project timelines and resources, serving as the bioanalytical representative for cross-functional project teams. Interact with internal and external partners, including Contract Research Organizations (CROs), to ensure project and scientific needs are met. Ensure all bioanalytical work is in compliance with relevant regulatory standards, including GLP, GCP, and ICH guidelines. Author, review, and approve critical regulatory documents, protocols, validation reports, and standard operating procedures (SOPs). Function as a key technical resource during regulatory inspections and client audits. Supervise, train, and mentor junior and senior scientists, fostering an environment of scientific excellence and professional development. Prioritize and schedule the workload of direct reports to meet project deadlines. Provide regular performance feedback and conduct annual reviews for team members. Present data, project updates, and scientific strategy to project teams, senior management, and clients. Contribute to scientific publications, presentations at conferences, and patent applications. Experience: Extensive, hands-on experience in bioanalytical method development, validation, and sample analysis within a regulated environment (GLP, GCP). Proven expertise with analytical techniques, including LC-MS/MS and Ligand Binding Assays (e.g., ELISA, MSD, Luminex). Experience with a variety of matrices such as plasma, serum, urine, and tissues. Demonstrated experience in leading projects, managing scientific staff, and fostering a collaborative team environment. Skills and Competencies: Exceptional problem-solving, troubleshooting, and analytical skills. Strong strategic and critical thinking abilities. Excellent written and verbal communication, and presentation skills. Proficiency with relevant software for data acquisition and analysis (e.g., Analyst, Softmax, LIMS). Deep knowledge of regulatory guidelines and industry best practices. Effective leadership and mentoring capabilities.
Position Summary: The Executive Regulatory Affairs (Biosimilars) will be responsible for the preparation, review, and submission of high-quality CMC documentation to support regulatory filings in the US, Europe, and other global markets. The role involves cross-functional collaboration, drafting of eCTD modules, and ensuring compliance with international regulatory requirements for biosimilar products. Role & responsibilities Review and finalize CMC (Chemistry, Manufacturing, and Controls) documents for US (FDA) and European (EMA) regulatory submissions. Draft, compile, and review eCTD sections , ensuring compliance with current regulatory and technical standards. Author and review key regulatory documents , including INDs, IMPDs, and Briefing Books (BBs) . Collaborate effectively with cross-functional teams (CFTs) such as Quality, Manufacturing, Analytical, and Clinical to gather required information and align on submission strategy. Ensure the use of appropriate regulatory language and consistency across all submission documents. Ensure documents meet PDF publishing and technical property requirements for eCTD submissions. Maintain up-to-date knowledge of ICH guidelines , regional regulatory frameworks , and biosimilar-specific requirements . Support regulatory strategy development and responses to health authority queries as needed Qualifications and Experience: Masters degree in Pharmacy, Biotechnology, Life Sciences, or a related discipline. Minimum 3 years of experience in CMC regulatory affairs with a focus on biosimilars . Hands-on experience with IND, IMPD, and eCTD submissions . Strong understanding of ICH and regional regulatory requirements for biosimilar development and registration. Proficiency with electronic publishing tools and eCTD document standards . Excellent communication, coordination, and documentation skills . Strong attention to detail, regulatory writing, and analytical skills.