Scientist 1, QC Analytical Development - Chemistry

We need to output HTML fragment with sections: headings

for sections present: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must include only sections with real specific content. The posting includes: Overview (company overview) maybe "About the role"? Actually "Job Description What You'll Do" is responsibilities. There's "Knowledge, Skills, And Abilities" which is skills. "Minimum Qualifications" and "Preferred Qualifications" are qualifications. There's no explicit Benefits, Pay, Schedule. There's "Physical Requirements" but that's not in list; we should not create a section for it unless it matches one of allowed headings. The allowed headings list is given; we should not create other headings. So we can either omit Physical Requirements or incorporate into something else? The instruction: "Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It suggests we can use those headings, but not required to use all. We should include sections only when posting has real specific content for it. So we need to map content to these headings. - About the role: could be the introductory paragraph describing role: "The Scientist 1, QC Analytical Development Chemistry supports the transfer of analytical Chemistry methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies, Holly Springs. This role ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines." That's about the role. - Responsibilities: "Job Description What You'll Do" bullet list. - Requirements: maybe "Minimum Qualifications" and "Physical Requirements"? But Physical Requirements not in allowed headings; maybe we can put under Requirements? The instruction says we can use those headings; we could treat Requirements as including minimum qualifications and maybe physical requirements. But we also have Qualifications separate. Could combine: Requirements = minimum qualifications? Qualifications = preferred qualifications? However they said prefer few substantive sections over many thin sections. Let's decide: Use sections: About the role, Responsibilities, Requirements (minimum qualifications), Qualifications (preferred qualifications), Skills (knowledge, skills, abilities). No Benefits/Pay/Schedule. We must not repeat job title as heading. Not include Job ID etc. Remove boilerplate: company overview maybe part of About the role? Actually company overview is separate paragraph about Fujifilm Biotechnologies. Could be part of About the role or maybe we could include as part of About the role? The instruction: "Preserve ALL substantive information". So we need to include company overview somewhere. Could be part of About the role or maybe a separate section like "About the company"? Not allowed heading. Could incorporate into About the role as a paragraph. We also need to include location info (Holly Springs, North Carolina...). That's substantive. We must not include EEO, legal, etc. We need to output only HTML fragment. Let's extract content: Intro: "The Scientist 1, QC Analytical Development Chemistry supports the transfer of analytical Chemistry methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies, Holly Springs. This role ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines." Company Overview: "FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers" Responsibilities (What You'll Do): list items: - Supports analytical chemistry method tech transfer and execution through method verification, transfer, and validation. - Interfaces with customers and program management to identify analytical needs and method gaps during project scoping. - Participates in meetings for TT programs with cross-functional teams and key stakeholders. - Authors technical documents including transfer and validation protocols/reports. - Communicates with QC testing teams, Quality Assurance (QA), and Process Science groups to ensure prioritization of non-compendial and compendial method transfer activities according to deadlines. - Collaborates with the LIMS team and IT department to build new analytical method functionality that meets end-user and customer requirements. - Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.). - Supports regulatory requests and inspections. - Supports the QCAD team to investigate any project challenges with necessary risk assessment tools and techniques. - Supports best practices for TT and PPQ strategies globally, as required. - Performs other duties, as assigned. Knowledge, Skills, And Abilities: - In-depth technical knowledge of Analytical Chemistry and ability to analyze raw data, assess assay and system suitability criteria. - Demonstrated application and knowledge of ICH guidelines on analytical method validation. - Demonstrate communication skills, technical proficiency, scientific creativity, collaboration with others and independent thought. - Excellent interpersonal skills including the ability to work as part of a cross-functional team, collaborate with external clients, adapt to changing business needs, communicate with confidence, challenge others when necessary and display strong problem-solving capabilities. - Excellent English oral and written communication skills as well as demonstrated expertise with Microsoft Excel, PowerPoint, Word, etc.. - Displays an advanced knowledge of GMP requirements for laboratory operations. - Possesses a broad knowledge of quality control operations, systems, and directives. - Must be flexible to support 24/7 manufacturing facility. Minimum Qualifications: - S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5+ years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO); OR, S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience; OR, D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 1+ years of experience. - Experience with analytical method transfers. - Experience with project management and demonstrated ability for providing regular updates and escalations. - Proficient in physical and chemical testing methods for biological products, including HPLC/UPLC chromatography (Protein A/G titer, SEC, PS80, glycans, peptide map); UVA280 and slope spectroscopy; capillary electrophoresis (CE-SDS, imaged capillary isoelectric focusing (icIEF)); general pharmaceutical properties methods. - 3+ years of experience working in a regulated GMP environment. - Relevant experience in analytical method development, transfer, and validation. Preferred Qualifications: - Experience with Customer Relationship Management. - Prior drug substance experience, including analytical method validation, transfer, commercialization, and manufacturing support and troubleshooting. Physical Requirements: we may omit because not in allowed headings. But we could incorporate into Requirements? The instruction says we can use those headings; we could treat Requirements as including minimum qualifications and physical requirements. But we already have Qualifications for preferred. Might be okay to have Requirements = minimum qualifications + physical requirements. However physical requirements is a list of demands; we could include as

under Requirements. But we must not invent sections; we can include physical requirements under Requirements as it's substantive. The heading "Requirements" is allowed. So we can put both minimum qualifications and physical requirements under Requirements. However we also have Qualifications for preferred. That seems okay. Thus sections: - About the role (intro + company overview + location) - Responsibilities - Requirements (minimum qualifications + physical requirements) - Qualifications (preferred qualifications) - Skills (knowledge, skills, abilities) No Benefits/Pay/Schedule. Now produce HTML: use

for each section heading, then content:

for prose,

• for lists. We need to ensure we don't repeat job title as heading. Not include any extra. Let's craft. About the role: combine intro paragraph and company overview. Might be two paragraphs. We'll output:

  About the role

  The Scientist 1, QC Analytical Development Chemistry supports the transfer of analytical Chemistry methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies, Holly Springs. This role ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines.

  FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

  Responsibilities:

  Responsibilities

  • Supports analytical chemistry method tech transfer and execution through method verification, transfer, and validation.
  • Interfaces with customers and program management to identify analytical needs and method gaps during project scoping.
  • Participates in meetings for TT programs with cross-functional teams and key stakeholders.
  • Authors technical documents including transfer and validation protocols/reports.
  • Communicates with QC testing teams, Quality Assurance (QA), and Process Science groups to ensure prioritization of non-compendial and compendial method transfer activities according to deadlines.
  • Collaborates with the LIMS team and IT department to build new analytical method functionality that meets end-user and customer requirements.
  • Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.).
  • Supports regulatory requests and inspections.
  • Supports the QCAD team to investigate any project challenges with necessary risk assessment tools and techniques.
  • Supports best practices for TT and PPQ strategies globally, as required.
  • Performs other duties, as assigned.
  Requirements: include minimum qualifications and physical requirements. We need to decide how to format minimum qualifications: it's a bit complex with OR statements. We'll keep as prose paragraphs or list items. Probably list each bullet. Minimum qualifications bullets: - S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5+ years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO); OR, S. in Chemistry,