Job Description
Senior Drug Product Small Molecule Consultant at
DSI - DS
InPharmatics, a PLG company Senior Drug Product Small Molecule Consultant at DSI - DS
InPharmatics, a PLG company in Edison, New Jersey Posted in 5 days ago. Type:
full-time Job Description:
DSI, the USA division of Product Life Group (PLG), a leading international pharmaceutical consulting organization, is looking for an experienced Senior Drug Product Consultant to support our expanding portfolio of drug development projects. This fully remote position offers the opportunity to apply your comprehensive knowledge of small molecule oral drug products, manufacturing processes, and equipment - including blending, granulation, compression, coating, and packaging - within a team-driven environment. Role and Responsibilities In this high-impact role, the Senior Drug Product Consultant will bring deep technical leadership to a diverse portfolio of pharmaceutical development programs. Working remotely within a collaborative consulting team, the successful candidate will: Lead formulation, development, launch, and optimization of oral solid and liquid drug products, including tablets, capsules, solutions, and suspensions Deliver risk assessments and technical support for parenteral products at all stages, from proof of concept through process validation Systematically investigate and resolve complex technical issues, designing targeted studies informed by broad drug product manufacturing knowledge Identify and mitigate issues across the full drug product continuum - development, manufacturing, packaging, storage, shipping, and stability Function as the primary technical SME in direct collaboration with client project leaders and CMOs to meet program objectives Execute phase-appropriate gap analyses, process remediation, regulatory inspection readiness assessments, and client training Serve as a trusted advisor, proactively flagging deviations from industry standards, regulatory expectations, or best practices Deliver actionable, phase-appropriate recommendations throughout all stages of drug product development Champion process optimization efforts to minimize line loss, enhance efficiency, and reduce manufacturing risk Qualifications and Education Requirements B.S. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline; an equivalent combination of relevant education, professional training, and experience will also be considered Minimum of 15 years of hands-on experience in solid dose pharmaceutical manufacturing, encompassing both development and commercial-scale operation Preferred Skills Extensive working knowledge of drug product development and manufacturing, with deep expertise in oral solid and liquid dosage forms including tablets, capsules, solutions, and suspensions Hands-on experience with validation and qualification of manufacturing equipment including high shear and fluid bed granulation, blending, milling, compression, and coating systems Demonstrated proficiency with production equipment, environmental controls, and container closure systems, including trending analysis and failure investigation Solid understanding of quality systems and QA compliance, encompassing control strategies, change control, non-conformance management, calibration, preventative maintenance, data analysis, and GMP documentation Current knowledge of industry standards and regulations, with experience engaging directly with Regulatory Authorities Proven experience in process scale-up, technology transfer, lean manufacturing, process excellence, DoE, CMC regulatory submission authoring, and CMO management Experience optimizing and transferring products at commercial-scale CMOs in the U.S. and internationally Strong technical writing skills with the ability to author and review protocols, reports, investigations, project timelines, and regulatory submissions Proficiency in statistical analysis and DoE software preferred Advanced Therapy Medicinal Products (ATMP) knowledge or experience is a plus Comfortable working independently and as part of a remote team with a consistent focus on client value Ability to identify knowledge gaps on the client side and proactively provide context and education to support informed decision-making Additional Notes Familiarity with a broad range of dosage forms and their associated manufacturing processes is considered a strong asset for this role. Candidates who bring cross-functional exposure beyond oral solid and liquid products will be particularly well regarded. The responsibilities outlined in this position description represent a general summary of the role and are not intended to be all-inclusive. PLG reserves the right to amend this description and may require the consultant to take on additional duties as business needs dictate. Occasional client-driven travel may be required. This is a terrific opportunity for a seasoned professional seeking to join a growing, market-leading organization at the forefront of regulatory drug development services, with deep expertise in Chemistry and Manufacturing. All applications are reviewed by our human hiring team. No automated screening or AI-based filtering is used to evaluate or eliminate candidates. Every candidate receives personal consideration.
