Imagine being at the forefront of delivering life-changing sterile medicines to patients around the world. As Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, you will play a critical role in advancing aseptic manufacturing operations by providing technical leadership, driving process performance, and supporting the successful introduction of new products and technologies. Working closely with Manufacturing, Quality, Engineering, and global partners, you will help solve complex challenges, lead continuous improvement initiatives, and ensure a reliable supply of high-quality products for patients. This is an exciting opportunity to make a meaningful impact in a collaborative environment that values innovation, scientific excellence, and operational excellence.
Responsibilities
Lead CPV activities by analyzing process data, identifying trends, and driving process performance improvements.
Serve as the MS&T technical lead for manufacturing investigations, root cause analysis, and issue resolution.
Partner with Manufacturing to support production schedules, commercial supply, and compliance with GMP requirements.
Monitor and trend CQAs and CPPs to ensure consistent product quality and process control.
Identify, evaluate, and implement process improvements that enhance reliability, efficiency, and performance.
Support the introduction of new equipment, systems, and manufacturing processes through startup and implementation activities.
Author and support process change documentation while collaborating with Engineering, Manufacturing, and Validation teams.
Provide technical expertise for remediation efforts, project deliverables, technical assessments, and process reports.
Collaborate with Development and site partners to execute Tech Transfer activities and ensure successful product commercialization.
Drive OPEX initiatives and foster a culture of continuous improvement, quality, and manufacturing excellence.
Essential Requirements:
Bachelor's degree in Biochemistry, Chemical Engineering, Bioengineering, or a related technical field with 6+ years of biopharmaceutical manufacturing experience; Master's degree with 4+ years of experience; or Doctorate degree with 2+ years of experience.
Proven experience supporting GMP biopharmaceutical manufacturing operations within a regulated environment.
Hands-on experience with aseptic fill-finish operations and sterile drug product manufacturing.
Experience supporting Tech Transfer, process validation, lifecycle management, or manufacturing process improvements.
Working knowledge of global GMP regulations, validation requirements, and quality compliance expectations.
Strong analytical skills with the ability to interpret process data, identify trends, and drive data-based decisions.
Excellent technical writing, communication, and cross-functional collaboration skills.
Demonstrated ability to lead technical initiatives and contribute effectively within cross-functional teams.
The company Compensation and Benefit Summary:
The salary for this position is expected to range between $114,100 and $211,900 annually
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining the company will be reviewed periodically. The company may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
LI-Onsite
Requirements
Applied Statistics, Change Controls, Cleaning Validations, Data Analytics, Emotional Resilience, Good Documentation Practices, Health, Safety, and Environment (HSE) Policy, Manufacturing Processes, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process Control, Process Validation, Quality Compliance, Regulatory Compliance, Risk Management, Technical Leadership, Technology Transfer
Conditions
This position will be located in Durham, NC and will be an onsite role.
The company is unable to offer relocation support for this role: please only apply if this location is accessible for you.