Senior/Principal Scientist – Bioseparation & Analytical Development

We need to produce HTML fragment with sections: Overview? The instruction says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We should not repeat job title as heading. The posting includes Overview, Responsibilities, Skills/Qualifications, Physical Demands, Company Overview, Diversity Statement (which is boilerplate EEO, should be removed). Also we need to remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we keep substantive info: Overview (maybe "About the role" or "Overview"? The instruction says use headings like About the role, Responsibilities, etc. We can choose appropriate headings based on content. The posting has "Overview Element Ann Arbor is currently seeking..." That's like a summary. Could map to "About the role". Then "Responsibilities" heading. Then "Skills / Qualifications" heading (maybe "Qualifications" or "Skills"). Then "Physical Demands" maybe not a standard heading but could be included under "Requirements"? However instruction says include a section ONLY when posting has real, specific content for it. Physical Demands is present with specifics: lifting 50 lbs occasionally, stand long periods, lift 50+lbs periodically. That's substantive. Should we create a section for Physical Demands? Not in the list of example headings but we can still use

with appropriate heading like "Physical Demands". The instruction says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It gives examples but not exclusive. Likely we can add other headings as needed. We'll include Physical Demands. Company Overview: Could be "About the company" or "Company Overview". Might be considered substantive. We'll include a section "Company Overview". Diversity Statement is EEO boilerplate, remove. We need to use

• for any list of duties/requirements/benefits, and

  for prose. We need to preserve ALL substantive information; do not invent or summarize away detail. So we need to keep all details from Overview, Responsibilities, Skills/Qualifications, Physical Demands, Company Overview. We must not repeat job title as heading. The job title is "Senior or Principal Scientist – Bioseparation". Not to be used as heading. We must not put Job ID/requisition numbers as headings (none present). We must remove duplicated lines. Need to check for duplicates: The responsibilities list repeats modalities multiple times; we should keep but not duplicate identical lines? The posting has repeated list of modalities in Overview and Responsibilities. We should keep both but not duplicate identical sentences? The instruction: "Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions." So we should remove duplicated lines that are exactly same. Let's scan. Overview paragraph: "Element Ann Arbor is currently seeking a highly experienced Senior or Principal Scientist – Bioseparation to lead and execute advanced analytical method development, characterization, and validation of large molecule therapeutics across discovery, development, and late-stage CMC. This is an onsite, laboratory-based role with significant hands-on responsibility in bioseparation sciences, supporting a broad range of biologics modalities including proteins and recombinant proteins, peptides and peptide-drug conjugates, monoclonal antibodies (mAbs) and biosimilars, antibody-drug conjugates (ADCs), mRNA therapeutics, DNA constructs (including plasmid DNA and oligonucleotides), viral vectors, and other complex or emerging modalities such as fusion proteins, multispecifics, and engineered biologics." Responsibilities first bullet: "Lead development, optimization, and troubleshooting of bioseparation-based analytical methods supporting biologics across discovery, development, and late-stage CMC, including orthogonal analytical strategies for comprehensive characterization" Second bullet: "Perform hands-on execution and technical leadership across a broad range of modalities, including proteins and recombinant proteins, peptides and peptide-drug conjugates, monoclonal antibodies (mAbs) and biosimilars, antibody-drug conjugates (ADCs), mRNA therapeutics, DNA/plasmid DNA/oligonucleotides, viral vectors, and emerging complex biologics (fusion proteins, multispecifics, engineered constructs)" This is similar to overview but not identical; it's okay. Third bullet: "Apply deep expertise in chromatography platforms (HPLC/UPLC/UHPLC, SEC, IEX, HIC, RP-HPLC, affinity chromatography), mass spectrometry (LC-MS/MS, high-resolution MS, SEC-MALS, native MS, MAM workflows, glycan/PTM characterization), capillary electrophoresis (CE-SDS, cIEF, purity/identity assays), and supporting biophysical techniques (DLS, DSC, UV/fluorescence, MALS, CD, FTIR)" Fourth bullet: "Lead analytical strategy for complex biologics programs, including method development, qualification, validation, transfer, comparability, stability, forced degradation, and full characterization studies" Fifth bullet: "Ensure development of robust GMP-compliant methods aligned with ICH Q2/Q6, USP, EP, and GMP requirements, and support regulatory submissions (IND, BLA, IMPD) with high-quality analytical data packages" Sixth bullet: "Drive innovation in analytical science, including implementation of MAM workflows, high-throughput LC-MS platforms, automated bioseparation methods, and evaluation of emerging technologies in biologics characterization" Seventh bullet: "Provide scientific leadership and mentorship to junior scientists, including troubleshooting complex bioseparation and mass spectrometry challenges and establishing best practices in analytical development and execution" Skills/Qualifications section: "BS in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field required; Master's degree or higher preferred, but not required.Extensive industry experience in biologics analytical development is highly desirable8–15+ years of experience in biopharmaceutical or CRO analytical development with strong hands-on expertise in bioseparation of large moleculesDeep technical expertise across analytical platforms, including LC/UPLC/SEC/IEX/HIC/RP chromatography, LC-MS and high-resolution mass spectrometry, CE-SDS, cIEF, SEC-MALS, and complementary biophysical techniques Strong scientific knowledge of protein structure and higher-order structure, monoclonal antibodies and biosimilars, antibody-drug conjugates (ADCs), engineered biologics, and nucleic acid-based therapeutics (mRNA, DNA, oligonucleotides)Demonstrated experience in comparability, stability studies, and degradation pathway analysis for complex biologicsPreferred experience includes CRO or client-facing analytical project execution, MAM workflows, advanced LC-MS analytics, glycan mapping and PTM quantification, and automation/high-throughput analytical systemsStrong scientific writing capability with experience supporting regulatory documentation and submissionsProven ability to execute in onsite laboratory environments with strong hands-on bioseparation and multi-platform analytical integration skillsAbility to manage complex biologics programs in fast-paced, matrixed environments with strong problem-solving and scientific reasoning capabilitiesEffective communicator across scientific, regulatory, and operational stakeholders" Physical Demands: "Physical Demands: Frequency of required physical force: Minimum (moderate)Lifting requirements: lifting 50 lbs. on occasionAbility to stand on feet for long periods of timeAbility to lift 50+lbs periodically" Company Overview: "Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to ‘Make tomorrow safer than today’. When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access. While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development. Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization." Diversity Statement: remove. We need to format with

  headings and

  or

  • . For responsibilities, we should use
    • . For skills/qualifications, also list items? It's a paragraph with many details separated by periods but no explicit list. Could we break into
      • for each distinct qualification? The instruction: "Use
        • for any list of duties/requirements/benefits". The skills/qualifications is not explicitly a list but could be considered requirements. Safer to keep as

          with sentences. However we could split into list items for clarity but risk adding structure not present. Better to keep as

          preserving original sentences. Overview: maybe

          . Physical Demands: could be

          • each requirement. Company Overview:

            . We must not include any extra text like explanations. Let's craft HTML:

            About the role

            Element Ann Arbor is currently seeking a highly experienced Senior or Principal Scientist – Bioseparation to lead and execute advanced analytical method development, characterization, and validation of large molecule therapeutics across discovery, development, and late-stage CMC. This is an onsite, laboratory-based role with significant hands-on responsibility in bioseparation sciences, supporting a broad range of biologics modalities including proteins and recombinant proteins, peptides and peptide-drug conjugates, monoclonal antibodies (mAbs) and biosimilars, antibody-drug conjugates (ADCs), mRNA therapeutics, DNA constructs (including plasmid DNA and oligonucleotides), viral vectors, and other complex or emerging modalities such as fusion proteins, multispecifics, and engineered biologics.

            Responsibilities

            • Lead development, optimization, and troubleshooting of bioseparation-based analytical methods supporting biologics across discovery, development, and late-stage CMC, including orthogonal analytical strategies for comprehensive characterization
            • Perform hands-on execution and technical leadership across a broad range of modalities, including proteins and recombinant proteins, peptides and peptide-drug conjugates, monoclonal antibodies (mAbs) and biosimilars, antibody-drug conjugates (ADCs), mRNA therapeutics, DNA/plasmid DNA/oligonucleotides, viral vectors, and emerging complex biologics (fusion proteins, multispecifics, engineered constructs)
            • Apply deep expertise in chromatography platforms (HPLC/UPLC/UHPLC, SEC, IEX, HIC, RP-HPLC, affinity chromatography), mass spectrometry (LC-MS/MS, high-resolution MS, SEC-MALS, native MS, MAM workflows, glycan/PTM characterization), capillary electrophoresis (CE-SDS, cIEF, purity/identity assays), and supporting biophysical techniques (DLS, DSC, UV/fluorescence, MALS, CD, FTIR)
            • Lead analytical strategy for complex biologics programs, including method development, qualification, validation, transfer, comparability, stability, forced degradation, and full characterization studies
            • Ensure development of robust GMP-compliant methods aligned with ICH Q2/Q6, USP, EP, and GMP requirements, and support regulatory submissions (IND, BLA, IMPD) with high-quality analytical data packages
            • Drive innovation in analytical science, including implementation of MAM workflows, high-throughput LC-MS platforms, automated bioseparation methods, and evaluation of emerging technologies in biologics characterization
            • Provide scientific leadership and mentorship to junior scientists, including troubleshooting complex bioseparation and mass spectrometry challenges and establishing best practices in analytical development and execution

            Qualifications

            BS in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field required; Master's degree or higher preferred, but not required. Extensive industry experience in biologics analytical development is highly desirable. 8–15+ years of experience