Sr. MSAT Materials Specialist

We need to output HTML fragment with sections: About the role? Actually the posting includes "Job Description" paragraph, then "Responsibilities", then "Essential Skills", "Additional Skills & Qualifications", "Work Environment", "Job Type & Location", "Pay And Benefits", "Workplace Type", "Application Deadline", "About Actalent". We need to use

for section headings: e.g., About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. But we must only include sections when posting has real specific content. We need to map content to these headings. We have: - About the role: could be the initial description paragraph: "We are seeking an MSAT Materials Specialist to take ownership..." That is about the role. So we can have

About the role

with

containing that paragraph. - Responsibilities: we have a list of responsibilities. Use

• . - Requirements / Qualifications: we have Essential Skills (education, experience) and Additional Skills & Qualifications. Could combine into Requirements or Qualifications. The instruction says use headings like Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide which to use. We have both essential and additional skills. Could put under "Qualifications" or "Skills". Probably "Qualifications" for education/experience, and "Skills" for additional skills. But we must not create thin sections. Let's see content: Essential Skills: Bachelor's degree... etc. That's qualifications. Additional Skills & Qualifications: soft skills, etc. That's also skills. We could combine both into one "Qualifications" section with both education/experience and skills. Or we could have "Skills" section for the additional skills, and "Qualifications" for education/experience. Both have substantive content, so okay. We also have Work Environment, Job Type & Location, Pay And Benefits, Workplace Type, Application Deadline, About Actalent. We need to map to allowed headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We have Pay And Benefits: we can split into Pay and Benefits sections. The posting gives pay range and benefits list. So we can have

  Pay

  with pay range paragraph, and

  Benefits

  with benefits list. Schedule: not provided. So we should not include Schedule heading. Requirements: maybe we can put the essential skills (education/experience) under Requirements. Qualifications: maybe additional skills? But the headings list includes both Requirements and Qualifications. We could use Requirements for essential skills (education/experience) and Qualifications for additional skills & qualifications. Or vice versa. Let's decide: - Requirements: Education and experience (Bachelor's degree... etc). That's a requirement. - Qualifications: Additional Skills & Qualifications (soft skills, etc). That's qualifications. - Skills: maybe we could also have a Skills section for technical skills like experience with assessing single-use materials, etc. But we already have those in essential skills. Could combine. But we must not create thin sections. Let's see if we can have: - About the role (description) - Responsibilities (list) - Requirements (education/experience) - Qualifications (additional skills & qualifications) - Benefits (list) - Pay (pay range) - Work Environment (maybe not allowed heading; but we could put under About the role? Not ideal. However the instruction says use headings only from that list; we should not create other headings like Work Environment, Job Type & Location, etc. So we need to fold those into allowed sections or drop them if they don't fit. The instruction: "Use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It says e.g., implying those are examples, but likely we should only use those headings. It also says "include a section ONLY when the posting has real, specific content for it". So we can only use those headings. So we need to map all content into those headings. If some content doesn't fit, we may need to incorporate into existing sections or drop if it's boilerplate. However we must preserve ALL substantive information; cannot drop substantive info. So we need to fit everything into those headings. Thus we need to decide which headings to use and place content accordingly. Possible mapping: - About the role: initial paragraph describing role. - Responsibilities: list of responsibilities. - Requirements: education/experience (Essential Skills). - Qualifications: Additional Skills & Qualifications (soft skills, etc). Or maybe Skills. - Skills: maybe technical skills like experience with assessing single-use materials, etc. But those are already in Essential Skills. Could split. - Benefits: benefits list. - Pay: pay range. - Schedule: not present, so omit. We also have Work Environment, Job Type & Location, Workplace Type, Application Deadline, About Actalent. These are substantive but not fitting headings. We could incorporate them into About the role or Responsibilities? For example, Job Type & Location could be added to About the role paragraph. Work Environment could be added to About the role or Responsibilities? Application Deadline could be a short paragraph maybe under About the role? About Actalent could be a separate section but not allowed heading; maybe we could put under About the role as well? However that would dilute. But the instruction says "Preserve ALL substantive information; do NOT invent or summarize away detail." So we must keep that info somewhere. If we cannot create a heading for it, we can embed it as a paragraph within an existing section, as long as we don't create a new heading. That's permissible. Thus we can have:

  About the role

  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. ... (maybe include other details like Job Type & Location, Work Environment, Workplace Type, Application Deadline, About Actalent). But that would be a huge paragraph; still okay. But we also need to keep the list of responsibilities separate. We also need to keep Essential Skills and Additional Skills & Qualifications separate maybe under Requirements and Qualifications. We also need Benefits and Pay. Let's craft:

  About the role

  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. This is a Contract position based out of Sanford, NC. The work environment 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%). The workplace type is fully onsite in Sanford, NC. This position is anticipated to close on Sep 27, 2026. 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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

  That's a lot but preserves all. Then Responsibilities:

  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.
  Then Requirements (education/experience):

  Requirements

  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