Technician, Research & Development

Piramal Pharma • Sellersville, PA

23h • Hybrid

About The Position

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO) that provides comprehensive drug development and manufacturing services throughout the drug lifecycle. They operate a global network of facilities across North America, Europe, and Asia, offering services such as Drug Discovery Solutions, Process & Pharmaceutical Development, Clinical Trial Supplies, and Commercial supply of APIs and Finished dosage forms. They also specialize in Highly Potent APIs and Antibody Drug Conjugation, serving both Innovator and Generic companies worldwide. The Technician, Research & Development role supports the R&D organization, focusing on Technical Services activities. This includes tasks related to registration, validation, technology transfer, process scale-up, process optimization, formulation and process support, and commercial production support for various pharmaceutical dosage forms. The position involves hands-on batch support, technical documentation, data compilation and verification, protocol execution, in-process sampling and testing, and preparing data for reports. The ideal candidate will have experience in pharmaceutical manufacturing/process support or laboratory/analytical testing and be capable of supporting both floor-based and office-based R&D and Technical Services activities.

Requirements

• Minimum of a bachelor’s degree in a scientific or technical discipline such as Chemistry, Biology, Microbiology, Engineering, Pharmaceutics, Pharmaceutical Sciences, or a related field.
• 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.
• 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.
• 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.

Nice To Haves

• 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.
• Experience with TrackWise and statistical or data analysis software such as JMP, Minitab, StatGraphics, or similar tools is preferred.
• Mechanical aptitude, problem-solving skills, curiosity, resourcefulness, and a continuous-improvement mindset are preferred.

Responsibilities

• 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, 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level