Sr. MSAT Materials Specialist

Job Description

Job Description

Job Title: MSAT Materials Specialist

Job Description

We are seeking an MSAT Materials Specialist to take ownership at one of our client sites for our Single-Use Program and serve as the technical authority for critical raw materials and single-use systems. This role involves supporting and maintaining material qualifications and establishing lifecycle management programs. The successful candidate will define material control strategies for both clinical and commercial manufacturing processes, evaluate material suitability for new products, process changes, and technology transfers, and conduct risk assessments for suppliers, materials, and manufacturing sites.

Responsibilities

• Own the Single-Use Program and serve as technical owner for critical raw materials and single-use systems.
• Support and maintain material qualification and establish lifecycle management programs.
• Define material control strategies across clinical and commercial manufacturing.
• Evaluate material suitability for new products, process changes, and technology transfers.
• Conduct supplier, material, and manufacturing site risk assessments.
• Define critical material attributes and assess impact on process performance and product quality.
• Ensure safety of single-use components materials for chemical compatibility, sorption, leachable/extractables, TSE/BSE, biocompatibility, and bioburden/sterility where needed.
• Ensure the safety of raw materials for Melamine, Nitrosamine, BSE/TSE for all materials and bioburden, and endotoxin per intended use.
• Serve as SME for material related manufacturing investigations.
• Support deviation investigations, root cause analyses, and CAPAs.
• Assess material contributions to process variability and product quality events.
• Lead material related continuous improvement initiatives.
• Evaluate supplier changes, material substitutions, specification updates, and process impact assessments.
• Support process transfers from development to commercial manufacturing.
• Author or review CMC sections related to raw materials and single-use systems.
• Support IND, BLA, MAA, and post approval submissions.
• Provide technical support during internal, customer, and regulatory inspections.
• Partner with Supply Chain and Procurement on supplier technical assessments.
• Review supplier quality data and technical documentation.
• Participate in supplier audits and performance reviews as required.

Essential Skills

• Bachelor's degree in Engineering or Life Sciences with 7 years of relevant experience, MS with 5 years, or PhD with 3 years.
• Experience in biologics GMP manufacturing.
• Strong understanding and experience in relevant areas of 21CFR, ICH guidance, multi-compendial criteria (USP, NF, EP, BP, JP), and FDA guidance documents.
• Proven knowledge in cGMP raw material and single-use consumable programs and material lifecycle management.
• Experience with assessing single-use materials for chemical compatibility, sorption, leachables, extractables, biocompatibility, TSE/BSE control, and control of particulates, bioburden, and endotoxin.
• Materials management experience.

Additional Skills & Qualifications

• Highly self-motivated with solid communication skills.
• Ability to work in a team environment and lead other professionals and peers.
• Strong organizational and time management skills with the ability to set priorities and attention to detail.
• High degree of flexibility, adaptability, and independence.
• Critical thinking, troubleshooting, and problem-solving skills.
• Experience working in cross-functional organizations with multitasking and prioritization abilities.
• Ability to mentor/train junior staff and manage contractors.
• Experience supporting commercial biologics, gene therapy, ATMP, or monoclonal antibody GMP manufacturing.
• Experience in a start-up environment and pre-clinical through commercial GMP Manufacturing.
• Understanding of industry expectations with respect to phase-appropriate requirements.
• Working knowledge of supply chain management, ERP and MES systems, and inventory management.

Work Environment

This role frequently requires long periods of sitting, standing, use of hands, and regular motion including bending, stooping, and lifting up to 20lbs. It may require working during non-traditional hours to support critical business operations. A hybrid working solution is available, allowing time to connect with colleagues at the office and the flexibility to work from home. On occasion, this role may require travel to other sites and/or vendors (0-5%).

This is a Contract position based out of Sanford, NC.

The pay range for this position is $65.00 - $110.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a Contract position based out of Sanford, NC.

This position is anticipated to close on Oct 27, 2026.

This is a fully onsite position in Sanford,NC.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.