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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Technician, Research & Development
Job Description
The Technician supports the R&D organization, with primary alignment to Technical Services activities, including registration, validation, technology transfer, process scale-up, process optimization, formulation and process support, and commercial production support for solid, semi-solid, and liquid pharmaceutical dosage forms. The role combines hands-on batch support with technical documentation, data compilation, data verification, protocol execution, in-process sampling/testing support, and preparation of tables, figures, and report content. The ideal candidate has experience in either pharmaceutical manufacturing/process support or laboratory/analytical testing, with the ability and willingness to support both floor-based and office-based R&D and Technical Services activities as project needs require.
- Support R&D and Technical Services projects, including registration batches, engineering/technical batches, process validation/PPQ activities, packaging validation, technology transfer, formulation/process development support, process scale-up, process optimization, and commercial production troubleshooting.
- Prepare and revise technical documents, including protocols, reports, technical assessments, batch/study summaries, inter-office correspondence, and other project documentation as needed for R&D and Technical Services projects.
- Compile, organize, trend, and verify batch, process, and analytical data from manufacturing records, laboratory results, batch documentation, and other approved sources for inclusion in protocols, reports, tables, charts, and graphics.
- Perform data entry, data checks, proofreading, and document review activities to support accurate and right-first-time R&D and Technical Services deliverables.
- Assist with execution of protocol-driven activities, including batch sampling, in-process monitoring, physical testing, and coordination of study-specific requirements during manufacturing, packaging, validation, registration, technical, and R&D batches.
- Complete and document physical testing of study, development, registration, or validation batches, as applicable, such as particle size distribution, bulk and tapped density, loss on drying, pH, viscosity, capsule or tablet weight, thickness, hardness, friability, and other dosage-form appropriate tests.
- Support preparation, review, and revision of master batch records, packaging records, change controls, SOPs, and other controlled documents related to R&D and Technical Services activities.
- Assist with evaluation or qualification activities related to alternate suppliers, API, excipients, packaging components, equipment change parts, process parameters, yield limits, hold times, and other process or product-related changes.
- Perform or assist with laboratory-scale, pilot-scale, and/or production-scale studies, batches, experiments, and investigations as assigned.
- Assist with process equipment qualification, facility/equipment-related studies, cleaning validation or verification support activities, and associated documentation, when applicable to the R&D or Technical Services scope.
- Communicate effectively with Formulation R&D, Technical Services, Analytical R&D, Quality Control, Quality Assurance, Manufacturing, Packaging, Engineering, Validation, Project Management, and other cross-functional groups to support project execution and documentation deliverables.
- Maintain cGMP documentation practices, data integrity, laboratory notebook entries, and compliance with applicable site procedures, safety requirements, health/environmental policies, and core values.
- Perform other assignments and tasks as required. Work hours may extend into evenings, weekends, or 2nd/3rd shift support depending on project schedules and manufacturing needs.
QUALIFICATIONS/REQUIREMENTS
- Minimum of an bachelor’s degree in a scientific or technical discipline such as Chemistry, Biology, Microbiology, Engineering, Pharmaceutics, Pharmaceutical Sciences, or a related field, with at least 3 years of relevant pharmaceutical industry experience; equivalent combinations of education and experience may be considered.
- Experience in one or more of the following areas is required or strongly preferred: Technical Services, Process Engineering, Process Validation, Formulation R&D, Analytical R&D, Quality Control, Manufacturing, Packaging, or related pharmaceutical operations.
- Experience supporting laboratory-scale and/or production-scale manufacture of solid oral, liquid, or semi-solid dosage forms is preferred. Familiarity with equipment such as mills, high-shear granulators, fluid beds, blenders, tablet presses, coaters, encapsulators, mixers, homogenizers, pumps, and packaging equipment is beneficial but not required for all candidates.
- Experience with sampling, physical testing, in-process checks, batch record review, analytical data review, data trending, or data verification is preferred.
- Technical writing experience and the ability to prepare clear, accurate, and well-organized protocols, reports, tables, charts, and summaries are required.
- Good computer, mathematics, and data handling skills are required. Experience with Microsoft Office applications is required; experience with TrackWise and statistical or data analysis software such as JMP, Minitab, StatGraphics, or similar tools is preferred.
- Demonstrated attention to detail, sound documentation practices, professional demeanor, and effective verbal and written communication skills are required.
- Ability to work independently under general direction while also working effectively in a cross-functional team environment.
- Ability to manage multiple assignments, organize priorities, and meet established project timelines in a high-demand environment.
- Ability to work in laboratory and production environments under required gowning, PPE, and respiratory protection conditions, as applicable.
- Mechanical aptitude, problem-solving skills, curiosity, resourcefulness, and a continuous-improvement mindset are preferred.
WORK ENVIRONMENT
The position requires the ability to work in both office and manufacturing/laboratory settings, with time spent performing floor-support activities in laboratory, manufacturing, and packaging areas. The position may require extended hours, including evenings and weekends, as well as support on 2nd or 3rd shift depending on project needs, batch schedules, and protocol execution requirements.
