7 Drug Product Jobs

Vaccine Manufacturing (Cell Culture) Responsible for cell revival, subculture, cell counting of MRC-5 cells. Preparation of MCB/WCB. Experience in handling Roller bottles, Cell stacks, TCFs. Preparation of MCB/WCB. Experience in Preparation of media and in process buffers in media mixing vessels. Experience in handling Roller bottles, Cell stacks, TCFs. Experience in virus infection, virus harvesting procedures. Experience in working with Chicken embryo fibroblast cells, pooling of embryos, seeding of RB’s . Quality Control Analyst Biochemical techniques, Chromatography techniques, Electrophoresis techniques, Immuno assay techniques Cell culture techniques, Molecular techniques Analytical method validation (AMV), Analytical Method Development and Transfer Quality control (QC), cGMP, cGLP and QMS. Drug Product (Filling-Officer/Executive/Sr. Executive/Operator) Experienced in handling of O-RABS, Operation of Vial washing/Filling/Lyophilizers/Autoclave/Process vessels.

You will be responsible for performing analyses of Drug Product and Drug Substances to evaluate various test parameters as per product development requirements. This includes Method Development of Drug Product and Method verification of Raw Materials. Additionally, you will compile analytical results and prepare Method Development Reports. It is essential to ensure adherence to GLP aspects in the analytical laboratory to maintain quality and accuracy in testing processes. The ideal candidate should have 0 to 3 years of experience in a similar role.,

The R&D Executive at PTC - MORAIYA will be responsible for performing analysis of Drug Product and Drug Substances for various test parameters according to product development requirements. This includes Method Development of Drug Product and Method verification of Raw Materials. The role also involves compiling analytical results and preparing Method Development Reports. Additionally, the R&D Executive will be responsible for ensuring Good Laboratory Practices (GLP) aspects in the analytical laboratory. The ideal candidate should have 0 - 3 years of experience in a similar role.,

Accountability Cluster Leading Drug Product activities SME of DP for biologics and biosimilars for Process Design, Quality management, and Manufacturing, Convincing experience in PFS operations SPOC for service providers and collaborators. Monitoring progress of the plan with high quality deliverables, provide technical expertise Providing technical support in device development for biosimilars Establish robust control strategy of process and its life cycle management Process Characterization and Process Validation Designing and execution of Process characterization studies Overseeing Process Validation studies with manufacturing support Managing the Product Life cycle management and Drive the external partnerships. Apply risk management principles and methodologies throughout lifecycle management including FMEA, gap analysis, etc. Suggest activities in improving the lead times in Product life cycle. Lead and oversee partnership with DP manufacturing site(s), implementing Control Strategy, Commercial Manufacturing, and Continued Process Verification (CPV). CMC Regulatory Develop and refine DP strategies that incorporate best practices and regulatory expectations Drafting reviewing regulatory sections for dossier submission to various agencies Provides Documentation support Draft and review all domain specific documents (protocol reports etc) Draft and review CTD sections for BLA submission Review GMP documents Innovation, Quality and technology advancement Supporting/overseeing establishment of PFS line at third party service provider Identify innovative & novel technologies in co-ordination with the suppliers to build future capabilities. Responsible for supporting and adhering to QMS at Aspergen Responsible for reviewing GMP QMS elements (deviations, Change controls, OOS etc) Educational qualifications: Ph.D. with 6+ years or Masters with 10+ years of relevant industry experience in biologics/bisimilars development for drug product manufacturing Relevant experience: Experience in DP development for commercialization including risk assessments, process characterization and validation, experience in biosimilars a plus. Experience in formulation will be a plus Extensive knowledge on DP process development and drug delivery for biologics and biosimilars in, pre-filled syringes and devices. Strong knowledge of regulatory guidelines and practices and experience authoring IND/BLA/MA sections. Experience in the development of drug-device combination product is a plus Candidate with experience in shipping validation will be preferred Candidate requires good understanding of CMC section of BLA submission requirements and expectation from regulatory agency. Experience in regulatory document writing for dossier submission. Good communication, writing and technical negotiation skills is must.

Roles and Responsibilities Develop new products by leading cross-functional teams through formulation development, process development, and scale-up. Collaborate with external partners (CROs) on OSD product development and registration dossiers preparation. Ensure compliance with regulatory requirements for solid oral products at CDSCO and DCGI. Manage budgets, resources, and timelines for R&D projects to achieve business objectives. Desired Candidate Profile 15-18 years of experience in pharmaceutical industry with expertise in AR&D. Bachelor's degree in Pharmacy (B.Pharma) followed by Master's degree (M.Pharma). Strong understanding of formulation development, formulation research, Nutraceuticals, OSDs. Proven track record of successfully leading complex projects from ideation to launch.

Roles and Responsibilities Develop and implement new product ideas through CDSCO process. Oversee research and development projects from concept to commercialization. Collaborate with cross-functional teams to ensure successful project delivery. Ensure compliance with regulatory requirements (DCgi) and maintain high standards of quality control. Desired Candidate Profile 15-18 years of experience in pharmaceutical industry, preferably in FR&D or similar role. B.Pharma degree in Any Specialization; M.Pharma preferred but not mandatory. Strong understanding of formulation development, formulations, nutraceuticals, OSDs, and solid orals.

Strategic: Representative for QMS activities in Drug product/ Drug substance area. Timely initiation and closure of QMS elements. Documentation related to Drug product/ Drug substance area. Training need identification for all the employees Assist the validations and routine validations of equipment and facility. Identify and implement the manufacturing and warehouse procedures with compliance to current GMP requirements. Coordination during customer and vendor audits. Coordinating with engineering and validation department for calibration and preventive maintenance. Coordination and implementation of software based QMS solutions like Track-wise, LMS, SAP etc. Operational: Initiation of change controls, deviations, Investigation and CAPAs and closure of the same. Tracking of QMS activities and coordinating with cross functional departments to complete the QMS activities like investigation for OOS, complaints, deviations. Identification, preparation and implementation of SOP’s. This position will prepare SOPs related to the machines which are undergoing commissioning and procedures which are proposed to implement in Drug product area. Preparation and review of URS, CLIA, SLIA, QRM, IQ and OQ documents. Involvement in the qualification activities of equipment and area in drug product area People: Champion the OneSource Core Values and lead by example by acting a member of a team to achieve organizational and common objectives. Identify business successors and coach, mentor, nurture and develop people towards leading the business as non-fungible assets in the organization with a succession and continuity plan. Preparation and execution of training modules on SOP’s in the department. Preparation and execution of QMS documents in the department. Preparation and execution of training modules on QMS and safety SOP’s in the department. Preparation and execution of training on soft skills to develop the team. Finance: Ensure activities, services and tasks engaged / managed meets or improves on budget, cost, volume and efficiency targets (KPIs) in line with business objectives. Ensure the availability / adequacy of resources to implement and maintain the pharmaceutical quality system and continually improve its effectiveness by applying resources to specific product, process or site.