Principal Automation Engineer, Bio-Assay

The businesses of Merck KGaA, Darmstadt, Germany; Billerica (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading company in the biopharmaceutical sector seeks a Principal Automation Engineer to implement automated solutions for bioassays, enhancing efficiency and throughput. The role involves developing analytical methods, training staff, and collaborating with cross-functional teams. Ideal candidates will have significant experience in bioassays and automation processes, contributing to impactful scientific advancements.

Qualifications

• 7+ years experience with Bachelor's or 5+ years with Master's in relevant fields.
• Hands-on experience with bioassays for monoclonal antibodies and related assays.

Responsibilities

• Develop and validate analytical methods for biopharmaceutical analysis.
• Create protocols and SOPs; transfer, qualify, or validate methods as needed.

Skills

Bioassays

Analytical Methods

Collaboration

Problem Solving

Education

Bachelor’s Degree

Master’s Degree

PhD

Tools

ELISA

PCR

qPCR

Sequencing

Job description

Work Location: Billerica, Massachusetts
Shift: No
Department: EF-ST-IA AIDD Automation
Recruiter: Anthony Johnson

This information is for internal use only. Please do not share outside of the organization.

Principal Automation Engineer, Bio-Assay

Your Role:

As a member of the AIDD team, you will be responsible for implementing automated solutions such as liquid handlers and other automation devices to increase efficiency and throughput for bioassays (biologics assays and immunoassays). You will onboard and validate assays onto high-throughput automated platforms, maintain device operability, and train others. You will also support the development, qualification, transfer, and validation of analytical methods for biologics analysis and characterization.

Responsibilities include:

• Develop and validate analytical methods for biopharmaceutical analysis on high throughput automated platforms.
• Create protocols and SOPs; transfer, qualify, or validate methods as needed.
• Develop bioassays and product characterization assays, supporting stability and in-process testing for various biologics, including viral vectors, mAbs, ADCs, bi-specifics, cell & gene therapies, etc.
• Participate in cross-functional teams within Biologics Development, sharing expertise and collaboratively solving problems.
• Develop protocols and SOPs, train staff, and maintain laboratory standards in line with departmental and company requirements.
• Stay current with scientific literature and technical developments relevant to analytical methods and equipment.

Location: Billerica, MA

Travel: <10%

Who You Are:

Minimum Qualifications:

• Bachelor’s Degree in relevant fields or equivalent experience with 7+ years, or Master’s Degree with 5+ years of experience.
• Hands-on experience with bioassays for monoclonal antibodies, ADCs, Bi-specifics, viral vectors, and related assays.
• Experience developing assays for biological activities such as antigen/receptor binding, signaling, cell death, and Fc functions.
• Knowledge of viral infectivity assays and cell & gene therapy products is a plus.
• Proficiency with bio & molecular techniques like ELISA, PCR, qPCR, sequencing, etc.
• Experience with bioassay development, optimization, transfer, qualification, and validation per ICH guidelines.

Preferred Qualifications:

• PhD in relevant fields.
• Strong experience with automated bioassay processes and robotic systems.
• Knowledge of scheduling software and integration in automated labs.
• Experience managing automation projects from conception to completion.
• Ability to work in fast-paced, entrepreneurial environments.
• Results-driven leader with collaborative style.

We offer a diverse, inclusive environment that fosters innovation and growth. Join us to make a meaningful impact in science and technology. Apply now and be part of a team dedicated to discovery and human progress!