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Salary: USD 114,100 - 211,900 / annual
DTX Pharma, a Novartis Company, is seeking a Senior Engineer in Manufacturing Science & Technology (MS&T) to lead aseptic drug product manufacturing operations in Durham, NC. This is an onsite role with no relocation support.
You will serve as a technical leader driving process performance, supporting new product introductions, and solving complex manufacturing challenges. Key responsibilities include leading Continued Process Verification (CPV) activities by analyzing process data and identifying performance trends; serving as the MS&T technical lead for manufacturing investigations and root cause analysis; partnering with Manufacturing to support production schedules and GMP compliance; monitoring Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs); identifying and implementing process improvements; supporting equipment and system implementations; authoring process change documentation; providing technical expertise for remediation and project deliverables; collaborating on Technology Transfer activities; and driving operational excellence and continuous improvement initiatives.
You will work cross-functionally with Manufacturing, Quality, Engineering, and global partners in a collaborative environment that values innovation and scientific excellence.
Required qualifications: Bachelor's degree in Biochemistry, Chemical Engineering, Bioengineering, or related field with 6+ years of biopharmaceutical manufacturing experience (or Master's with 4+ years, or Doctorate with 2+ years). Proven experience in GMP biopharmaceutical manufacturing within regulated environments; hands-on experience with aseptic fill-finish and sterile drug product manufacturing; experience with Tech Transfer, process validation, lifecycle management, or manufacturing improvements; working knowledge of global GMP regulations and validation requirements; strong analytical and data interpretation skills; excellent technical writing and cross-functional collaboration abilities; and demonstrated ability to lead technical initiatives.
