Highlights
A biotechnology organization is seeking a Materials Specialist to support the onboarding, qualification, and lifecycle management of single-use materials used in AAV drug substance and drug product manufacturing. Coordinate testing activities with external laboratories and suppliers, track study progress, and summarize analytical results for technical assessments.
Numbers & Facts
| Location | Bedford, Massachusetts |
| Industry | Staffing/Employment Agencies |
| Salary | $50–$70 Per Hour |
| Company Size | 100 to 499 employees |
| Year Founded | 1985 |
| Website | http://www.tandymgroup.com |
Description
A biotechnology organization is seeking a Materials Specialist to support the onboarding, qualification, and lifecycle management of single-use materials used in AAV drug substance and drug product manufacturing. This role focuses on technical assessment, documentation, and cross-functional collaboration within a regulated manufacturing environment.
About the Opportunity:
- Shift: Day shift
- Hours: Standard business
- Setting: Hybrid
Responsibilities:
- Support onboarding and qualification of single-use manufacturing components, including bags, tubing, filters, connectors, and assemblies.
- Perform material assessments and extractables/leachables risk assessments using established SOPs, templates, and risk assessment tools.
- Review supplier documentation, material certifications, extractables reports, and technical packages to support material qualification.
- Develop and document testing recommendations and requirements for material qualification activities.
- Coordinate testing activities with external laboratories and suppliers, track study progress, and summarize analytical results for technical assessments.
Qualifications:
- 3-6 years of experience in biotechnology, pharmaceutical, medical device, or another regulated industry
- B.S. or M.S. in Materials Science, Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or a related scientific discipline
- Experience with single-use systems, manufacturing materials, or extractables and leachables assessments
- Strong technical writing skills and attention to detail
Desired Skills:
- Experience supporting material-related change controls, investigations, and impact assessments
- Familiarity with GMP documentation practices and qualification records
- Exposure to cross-functional collaboration with MSAT, Process Development, Manufacturing, Quality Control, and Quality Assurance teams
About Company
At Tandym Group (formerly The Execu|Search Group), we’re committed to connecting talented people like you with leading companies. With our personalized approach, you’ll never feel like just a resume when you work with us. We know that every job—and every job seeker—is different, which is why we keep the focus on you and your goals. This philosophy has allowed us to help thousands of people find career success over the last three decades, and we’re here to help you do the same.
With our extensive network of companies and full suite of direct hire recruitment and contract staffing services, you’ll have access to a variety of roles. We match talent with highly curated opportunities across healthcare, professional services, tech, and life sciences—but it goes far beyond that.
When you partner with us, we’re all in. Your goals become our goals, and we are committed to helping you reach your highest potential. From matching you with your dream role to providing resume guidance and interview prep, we’re here for the entire journey. In the constantly changing world of work, you can count on us to be by your side.
With our extensive network of companies and full suite of direct hire recruitment and contract staffing services, you’ll have access to a variety of roles. We match talent with highly curated opportunities across healthcare, professional services, tech, and life sciences—but it goes far beyond that.
When you partner with us, we’re all in. Your goals become our goals, and we are committed to helping you reach your highest potential. From matching you with your dream role to providing resume guidance and interview prep, we’re here for the entire journey. In the constantly changing world of work, you can count on us to be by your side.