MSAT Drug Product Lead (Associate Director level)
$125,250–$208,750 year
HybridZebulon, North Carolina, United States
Job Summary
Manage the Manufacturing Science and Technology Drug Product technical delivery for new product introductions and successful product launches, including delivering right-first-time product qualifications. Act as the single technical point of contact for the drug product portfolio, owning technical risk, decision-making, and product knowledge while leading technology transfers to internal sites and external manufacturers. Drive right-first-time execution of product qualification activities, manage continued process verification, and define product control strategies with clear documentation for operations. Support regulatory submissions, post-approval inspections, and complex investigations through root cause analysis and corrective actions. This hybrid role requires site visits and offers growth within a global biopharma company focused on specialty medicines and vaccines to prevent and treat disease.
Required Qualifications
- Bachelor's degree in a relevant scientific, engineering or technical discipline
- Minimum 10 years' experience in pharmaceutical development, manufacturing or MSAT roles
- Demonstrated experience in technology transfer, process validation and product lifecycle technical leadership
- Practical knowledge of Good Manufacturing Practice (GMP) and regulatory expectations for drug product manufacture
- Experience applying risk assessment approaches, process control strategies and quality tools to maintain product performance
- Familiarity with regulatory dossiers and supporting health authority questions
- Strong written and verbal communication skills and experience working with multi-disciplinary teams
- Hands-on experience with oral solid dose drug product manufacturing
Desired Qualifications
- Advanced degree (MSc, PhD) in a relevant scientific or engineering discipline
- Experience with Quality by Design, continued process verification and statistical process control
- Track record of leading complex technical investigations and delivering sustainable corrective actions
- Experience supporting regulatory filings, inspections and readiness activities
- Ability to lead improvement projects that demonstrate measurable technical or operational value
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