Senior Manager, Process Engineer - Drug Product

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Manager, Process Engineer - Drug Product in United States.This role provides a unique opportunity to lead and optimize drug product manufacturing processes, primarily for oral dosage forms, in collaboration with Contract Manufacturing Organizations (CMOs). You will play a pivotal role in ensuring process validation, scale-up readiness, and consistent product supply while acting as a key liaison between internal teams and external manufacturing partners. The position requires both hands-on engineering expertise and strategic oversight, enabling the seamless transfer of processes from development to commercial production. You will review, analyze, and improve manufacturing documentation, data packages, and operational procedures to support compliance with regulatory standards. Travel to manufacturing sites may be required, offering exposure to diverse environments and a global operational perspective. Success in this role directly impacts product quality, regulatory compliance, and operational efficiency.Accountabilities:Lead validation, scale-up, and optimization of drug product manufacturing processes for oral dosage formsServe as the primary point of contact with CMOs to ensure clear communication, process knowledge transfer, and operational alignmentAuthor process manuals, scale-up spreadsheets, and technical documentation to support industrial execution and regulatory filingsReview batch records, in-process controls, non-conformance reports, and developmental reports to ensure adherence to cGMP standardsCollaborate with Quality Assurance to maintain compliance with industry regulations, standards, and internal policiesIdentify and implement process improvements to enhance efficiency, product quality, and supply reliabilityTravel to manufacturing sites as needed for process implementation, troubleshooting, and operational supportRequirementsAdvanced degree (MS or equivalent preferred) in Chemical Engineering, Pharmaceutical Sciences, or a related engineering field8 years of applied experience with a BS degree or 6 years with an MS degree in drug product manufacturing, process engineering, or CMO managementIn-depth knowledge of pharmaceutical operations including sifting, milling, blending, roller compaction, tableting, and coating processesExperience reviewing batch records, operating procedures, non-conformance reports, and change controls in regulated environmentsStrong written, visual, and verbal communication skills for effective internal and external collaborationHighly organized, detail-oriented, self-motivated, and able to contribute to a productive, collaborative team environmentFamiliarity with regulatory guidelines, cGMP compliance, and quality systems in pharmaceutical manufacturingBenefitsCompetitive base salary ($145,000—$167,000 USD) with potential adjustments based on experience and educationComprehensive medical, dental, and vision coverage with 99% of premiums paid by the companyCompany-paid life insurance, AD&D, and disability benefits, with additional voluntary coverage options401(k) plan with dollar-for-dollar match up to 6%, plus long-term stock incentives and Employee Stock Purchase Plan (ESPP)Discretionary quarterly bonuses and generous paid time off, including company-wide holidays and shutdownsFlexible work environment with the opportunity to travel as needed to support global operationsCollaborative, high-performing team culture focused on innovation, quality, and shared successJobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.📊 It compares your profile to the job's core requirements and past success factors to determine your match score.🎯 Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role.Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.Thank you for your interest!