Material Qualification Engineer

Lancesoft; Lexington (MA); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work arrangement

On-site 3 days/week

Job summary

MA Bio Ops in Lexington & Cambridge, MA seeks a Material Qualification Engineer to lead MQ activities for single-use components and DS materials, write protocols, generate reports, and support tech transfer and lifecycle management.

The role interfaces with QA, MSAT, Process Development, and Supply Chain, ensuring MQ contributions become part of site processes. A Bachelor's in engineering with 4+ years or Master's with 2+ years is required.

Hybrid work arrangement; on-site 3 days/week.

Qualifications

• Essential: Bachelor's in relevant engineering or sciences with 4+ years experience or Master's with 2+ years.
• Desirable: pharma/biotech experience, with mAb manufacturing knowledge.
• Familiarity with single-use manufacturing equipment design and testing, plus supplier knowledge.

Responsibilities

• Write, execute, analyze MQ activities and summarize results across tech transfer, change management, and lifecycle management.
• Develop MQ protocols, reports, and documentation for single-use components and raw materials.
• Support regulatory and quality systems, CAPAs, deviations, inspections, and supplier QA activities.

Skills

Material science

Mechanical engineering

Biomedical engineering

Chemical engineering

Quality systems

Regulatory awareness

Education

Bachelor's in Material Science/Mechanical/Biomedical/Chemical Engineering or related field

Master's in related field

Tools

Single-use equipment design

Extractables & Leachables

GMP/QA processes

Job description

Actual Job Title - Material Qualification Engineer Primary Duties

The individual will be expected to provide material qualification (MQ) support for THE CLIENT Massachusetts Biologics Operations (MA Bio Ops) site located in Lexington & Cambridge MA, USA. The MQ activities related to the Lexington & Cambridge manufacturing site include, but are not limited to, the following areas: Development of MQ protocols, reports and other documentation for single use components and QC released raw materials within all manufacturing processes. Developing MQ validation packages including acquisition of necessary data and summation into final reports. Supporting the Human Daily Exposure (HDE) program including technical assessments and Extractables/Leachables (E/L) caclulations to ensure patient safety related to commercial Drug Substance (DS) Manufactured at MA Bio Ops Providing MQ related technical, compliance and quality support to the TAK-921 Tech transfer team as required. Assisting technical assessments on change controls, deviations and investigations, assessing proposed changes to validated process components to identify requirements necessary to maintain validated status. Represent MQ in meetings and participating in operations, engineering, quality, MSAT and new prodict introduction related strategy discussions as required. Interface with other site functions including procurement, quality, manufacturing, engineering, compliance and process development to effectively communicate requirements for material qualification and ensure they are a part of routine site business processes.

Job Function and Description (75% of the time) Write, execute, analyze results and summarize MQ activities in the following areas: Tech transfer (new product introduction) Change management Continuous lifecycle management Develop and assess the following Quality System elements for material qulaification: Quality Risk Management program CAPAs Change Controls Deviations GMP Investigations Vendor Change Notifications Champion site projects involving QC released chemicals and single use raw materials: Lead development of technical strategy/philosophy for MQ activities Represent MQ during tech transfer activities as required. Represent MQ during site GMP activities and participate on cross-functional teams Own MQ Quality Systems, as required, and manage project through to closure per timelines (20 % of the time) Identify and deploy opportunities for continuous improvements and adoption of best practices. Represent MA Bio Ops MQ in the global MQ community of practice. (5% of the time) Participate in regulatory agency inspections for MQ.

Education and Experience Requirements Essential: Bachelor's in Material Science, Mechanical, Biomedical or Chemical Engineering or related science or engineering field with a minimum of 4 years relevant experience or Master s in related field with a minimum of 2 years relevant experience. Desired: Prior experience working in the pharmaceutical or biotech industry, with mAb manufacturing (upstream or downstream) knowledge. Knowledge of single use manufacturing equipment design, and Single use and chemical specification and qualification. Familiarity with major suppliers of materials, standards for material selection and methods for testing the quality attributes as well as leachable and extractables.

Soft Skill and Project Management Requirements The candidate: Will exercise judgment within defined procedures/practices to determine appropriate action. Must have the ability to analyze data, quantify risks, and identify gaps independently. Must have the ability to propose solutions to problems and escape issues with proposed solutions to management as necessary. The person in this role will be instrumental in working with other members of the Quality Assurance, Quality Control, Supplier Quality, Supply Chain, Manufacturing and Engineering organizations to develop and execute MQ studies and projects to enhance the manufacturing systems and processes to compliantly and efficiently achieve organizational goals. Other departments this person will work closely with include: Process Development, Process Validation, Regulatory Affairs, and Facilities.

Other Job Requirements This is a Hybrid role with the expectation to be present on-site 3 days a week from Tuesday to Thusday.