Sr. Engineer I, Drug Product MS&T

The Role

In this role, you will be a key technical leader in the organization, responsible for managing complex investigations, providing drug product technical leadership, and ensuring product technical stewardship. This role requires a strong understanding of the fill-finish process, inspection, packaging, and labeling of pharmaceutical products. The ideal candidate will have a proven track record in developing product technical strategies and leading cross-functional teams to maintain product quality, efficacy, and compliance throughout the product lifecycle. Experience in new facility build-outs and new equipment qualification is highly desirable, including involvement in design, commissioning, and validation activities to ensure operational readiness for drug product manufacturing. Specific skill sets/role will include:

• Management of complex DP investigations: Investigation management, Root cause analysis, Risk assessment, CAPA, Documentation and Reporting, Decision-Making, Problem solving, compliance monitoring

• Technical Drug Product Stewardship in support of clinical programs: Product technical strategy, engagement with technical development and manufacturing to identify solutions to complex technical challenges, product risk management, process benchmarking, technical support and troubleshooting, process development and optimization, innovation and product development

• New equipment and facility build out: Equipment installation and commissioning, Facility design and construction, Inspection systems installation and implementation, Labeling technology and machinery set up, Packaging line design and setup for clinical and commercial, Engineering design principles, technology transfer in support of insourcing and outsourcing

Here’s What You’ll Do

• Lead and manage complex technical investigations to address deviations, out-of-specification results, and other product-related issues.

• Serve as the technical lead for drug product teams, providing strategic direction and expertise in fill-finish, inspection, packaging, and labeling operations.

• Assume responsibility for product technical stewardship, ensuring that all aspects of drug product manufacturing are compliant with regulatory requirements and industry best practices.

• Develop and implement product technical strategies that align with the company's objectives and market demands.

• Collaborate with cross-functional teams, including R&D, Quality, Regulatory Affairs, and Operations, to ensure seamless technology transfer and scale-up of drug products.

• Drive continuous improvement initiatives to enhance process robustness, increase efficiency, and reduce costs while maintaining product quality.

• Provide technical input during regulatory submissions and respond to questions from health authorities.

• Author and review technical documentation, including validation protocols, standard operating procedures (SOPs), and technical reports.

• Mentor and develop junior MS&T staff, fostering a culture of technical excellence and knowledge sharing.

• Represent the MS&T department in strategic planning discussions and provide expert guidance on technical matters

• Experience in new facility build-outs and new equipment qualification is highly desirable, including involvement in design, commissioning, and validation activities to ensure operational readiness for drug product manufacturing.

Here’s What You’ll Need (Basic Qualifications)

• Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.

• Minimum of 7 years of relevant experience in the biotechnology or pharmaceutical industry, with a focus on drug product manufacturing.

• Extensive experience managing complex technical investigations and providing technical leadership for drug products.

• Strong technical background in fill-finish, inspection, packaging, and labeling processes for pharmaceutical products.

• Demonstrated ability to develop and execute technical strategies for drug products.

• Excellent problem-solving skills with a systematic approach to root cause analysis.

• Familiarity with regulatory requirements and guidelines for pharmaceutical manufacturing (e.g., FDA, EMA, ICH).

• Strong leadership and communication skills, with the ability to influence and collaborate effectively with various stakeholders.

• Proficient in data analysis and interpretation, with a solid understanding of statistical methods.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Product technical stewardship

• Experience in new facili