Senior Manager, Process Engineer - Drug Product at Jobgether

, , United States -

Full Time

Start Date

Immediate

Expiry Date

06 Feb, 26

Salary

167000.0

Posted On

08 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Engineering, Drug Product Manufacturing, cGMP Compliance, Quality Assurance, Process Validation, Scale-up Readiness, Operational Efficiency, Documentation Review, Batch Records, Non-conformance Reports, Process Optimization, Communication Skills, Regulatory Standards, Team Collaboration, Detail-oriented, Self-motivated

Industry

Internet Marketplace Platforms

Description

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 forms. Serve as the primary point of contact with CMOs to ensure clear communication, process knowledge transfer, and operational alignment. Author process manuals, scale-up spreadsheets, and technical documentation to support industrial execution and regulatory filings. Review batch records, in-process controls, non-conformance reports, and developmental reports to ensure adherence to cGMP standards. Collaborate with Quality Assurance to maintain compliance with industry regulations, standards, and internal policies. Identify and implement process improvements to enhance efficiency, product quality, and supply reliability. Travel to manufacturing sites as needed for process implementation, troubleshooting, and operational support. Advanced degree (MS or equivalent preferred) in Chemical Engineering, Pharmaceutical Sciences, or a related engineering field. 8 years of applied experience with a BS degree or 6 years with an MS degree in drug product manufacturing, process engineering, or CMO management. In-depth knowledge of pharmaceutical operations including sifting, milling, blending, roller compaction, tableting, and coating processes. Experience reviewing batch records, operating procedures, non-conformance reports, and change controls in regulated environments. Strong written, visual, and verbal communication skills for effective internal and external collaboration. Highly organized, detail-oriented, self-motivated, and able to contribute to a productive, collaborative team environment. Familiarity with regulatory guidelines, cGMP compliance, and quality systems in pharmaceutical manufacturing. Competitive base salary ($145,000—$167,000 USD) with potential adjustments based on experience and education. Comprehensive medical, dental, and vision coverage with 99% of premiums paid by the company. Company-paid life insurance, AD&D, and disability benefits, with additional voluntary coverage options. 401(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 shutdowns. Flexible work environment with the opportunity to travel as needed to support global operations. Collaborative, high-performing team culture focused on innovation, quality, and shared success. Jobgether 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! #LI-CL1

Responsibilities

Lead and optimize drug product manufacturing processes for oral dosage forms while ensuring process validation and scale-up readiness. Act as a liaison between internal teams and external manufacturing partners to maintain product quality and regulatory compliance.