Senior Scientist, Quality Control Analytical

We need to output HTML fragment with sections: About the role? Actually we need to use

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must include sections only when posting has real specific content. We need to extract content from the job posting. Let's parse: Company Overview: description of company. Could be "About the role"? Actually "Company Overview" is about the company, not role. The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we need to map content accordingly. We have Position Summary, Essential Functions (these are responsibilities). Education & Experience (qualifications). Knowledge, Skills, & Abilities (skills). Working Environment / Physical Environment (maybe schedule? but not exactly). Benefits: listed later. Pay: given. Schedule: maybe "Flexibility in working schedule, i.e., off-hours". So we can include Schedule section. We must not repeat job title as heading. No Job ID. We must remove boilerplate: cookie/navigation/legal/EEO etc. At end there is EEO statement, we must remove. We must preserve all substantive information. Let's extract sections: About the role: Could be Position Summary? Or maybe we can use "About the role" heading and put Position Summary content. Responsibilities: Essential Functions. Requirements: Education & Experience? Or maybe Requirements separate from Qualifications. The instruction includes both Requirements and Qualifications headings. We need to decide what goes where. Typically Requirements = education/experience; Qualifications = maybe specific skills? But we also have Knowledge, Skills, & Abilities. Could map: Requirements = Education & Experience; Qualifications = maybe "Extensive experience with assay development..." etc? But that seems overlapping. However we have both sections available; we can put Education & Experience under Requirements, and maybe "Extensive experience with assay development..." etc under Qualifications? But the posting already has "Education & Experience" then "Knowledge, Skills, & Abilities". There's no separate "Qualifications" heading. But we can still create Qualifications section only if there is real specific content. We could treat "Education & Experience" as Qualifications? Actually the instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we need to decide mapping. We have content: - Position Summary (role description) - Essential Functions (responsibilities) - Education & Experience (requirements) - Knowledge, Skills, & Abilities (skills) - Working Environment / Physical Environment (maybe schedule) - Benefits (list) - Pay (salary range) - Schedule (flexibility) We could map: About the role -> Position Summary Responsibilities -> Essential Functions Requirements -> Education & Experience Qualifications -> maybe we could combine some of Knowledge, Skills, & Abilities? But that is more Skills. Actually Knowledge, Skills, & Abilities is skills. So we can put that under Skills. Thus we may not need Qualifications separate; we can omit if no specific content beyond what's covered. But we have "Extensive experience with assay development, qualification, validation, and transfer activities." etc which is under Education & Experience? Actually that is under Education & Experience bullet list. So Qualifications may be redundant. We'll omit Qualifications heading if no distinct content. Skills -> Knowledge, Skills, & Abilities. Benefits -> list of benefits. Pay -> salary range. Schedule -> flexibility in working schedule. We also have Working Environment / Physical Environment: maybe we could include under Schedule or as its own section? Not in allowed headings. Could incorporate into Schedule or maybe omit. But we need to preserve all substantive information. The working environment includes: site in Dunkirk, NY, flexibility in schedule, performs work in lab as needed, etc. We could put that under Schedule (flexibility) and maybe also under Responsibilities? But better to create a section maybe "Working Environment" not allowed. Could we put under Schedule? The schedule heading is for schedule info; we could add extra details about location and lab work under Schedule? Might be okay but could be mixing. However instruction: include a section ONLY when posting has real, specific content for it — never emit a heading followed by filler/placeholder text. It doesn't forbid adding extra content beyond schedule under that heading. So we can put location and lab work under Schedule section. But we also have "This position is eligible for a discretionary bonus and equity award." That's compensation beyond base pay; could be included under Pay or Benefits? Probably Pay. Now we need to output HTML fragment: use

for headings,

• for lists,

  for prose. We must not include or . No markdown fences. Let's craft:

  About the role

  Position Summary The Senior Scientist, Quality Control Analytical provides analytical testing leadership for various programs such as fusion proteins, cell therapies and cancer vaccines. The analytical testing will include but is not limited to the wet chemistry, chromatography (HPLC, Capillary Electrophoresis), spectroscopy (UV-Vis), and ELISA. The position will also take on a lead role for providing testing support through In Process testing, and suitability for use testing, method development, optimizations, transfer, qualification work and investigational studies. The Senior Scientist will undertake complex troubleshooting and investigations.

  Responsibilities

  • Develop strategies, and support the introduction, validation and on-going technical agenda for pipeline and commercial analytical chemistry methods and technology.
  • The polishing of analytical methods to implement GMP-friendly structure into the method.
  • Drafting and reviewing of protocols, reports, and methods to support the method validation lifecycle.
  • Complex troubleshooting of methods
  • Development of new assays to support raw material, in process, drug substance, or drug product release and stability testing.
  • As required, provide training or mentorship to other QC or cross functional team members.
  • Act as Subject Matter Expert (SME) for analytical chemistry within QC. This may include the identification, purification and separation of the components in an unknown mixture.
  • Complete structural analytical characterization (via experimental analysis or review of outsource reports) on various drug products, including product related impurities.
  • In the event of non-conformance to acceptable quality and/or safety standards (including invalid assays), lead analytical investigations, using Root Cause Analysis techniques where appropriate.
  • Work with the QC team to improve the state of validation and drive analytical variability reduction.
  • Draft and edit documents, Standard Operating Procedures (SOPs) and test plans as needed.
  • Lead continuous improvement activities to help improve the overall operations of the testing labs.
  • Track / trend key performance indicators and identify adverse events in testing and escalate as needed to prevent reoccurrence.
  • Partner with colleagues in various departments (e.g., AD/PD, Facilities, Engineering, QA and Regulatory) to ensure achievement of company goals.
  • Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

  Requirements

  Education & Experience Master’s degree in Analytical Science (chemistry, biochemistry, or other scientific related field) with at least 7 years of experience in the biotechnology industry required; or Ph.D. in Analytical Science (chemistry, biochemistry, or other scientific related field) with at least 3 years of experience in the biotechnology industry required. Extensive experience with assay development, qualification, validation, and transfer activities. Experience working in cGMP laboratory required. Hands-on experience with HPLC and ELISA required. Hands-on experience with biological assays (e.g. cell cultures) preferred.

  Skills

  • Working knowledge of QC testing requirements, methodology, and general equipment such as pH meter and analytical balance
  • Knowledge of cGMP, FDA, and USP regulations and a basic understanding of statistics
  • With safety as the priority excellent laboratory techniques
  • Proficiency in the use of multiple HPLC instrument platforms (e.g. Thermo, Agilent, etc.)
  • Strong technical problem-solving ability both independently and as part of a team.
  • Motivated to work independently to produce high quality work in an efficient manner.
  • Strong computer skills, including Microsoft Office
  • High attention to detail in all aspects of the work
  • Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects simultaneously.
  • Excellent communication skills, with the ability to effectively interact with cross-functional teams, senior management, and external entities.
  • In-depth knowledge in analytical method development and validation, and statistical quality control.
  • Ability to use sound scientific judgment in management of the facility and processes to prevent regulatory action.
  • Deep understanding of GMPs, SOPs, and pharmaceutical regulations, and an ability to interpret and enforce regulatory requirements.
  • Ability to define problems, collect data, establish facts and draw valid conclusions.
  • Ability to analyze and interpret complex, scientific documents, including problem solving.

  Benefits

  • Medical, Dental and Vision Plan Options
  • Health and Financial Wellness Programs
  • Employer Assistance Program (EAP)
  • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
  • Healthcare and Dependent Care Flexible Spending Accounts
  • 401(k) Retirement Plan with Company Match
  • 529 Education Savings Program
  • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
  • Paid Time Off (PTO) includes: 11 Holidays
  • Exempt Employees are eligible for Unlimited PTO
  • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day

  Pay

  The annual base pay range for this position is $125,000 (entry-level qualifications) to $137,500 (highly experienced) annually. This position is eligible for a discretionary bonus and equity award.

  Schedule

  This position works on site in Dunkirk, NY. Flexibility in working schedule, i.e., off-hours. Performs work in the lab as needed to supervisor staff and oversee quality control programs. Performs work in the lab to execute experiments.

  We must ensure no boilerplate like EEO etc. We removed that. Check for any repeated content: we included all substantive info. Check for any missing: The company overview description at start: "Company Overview ImmunityBio is a vertically integrated..." Should we include that? Possibly under About the role? But we already used About the role for Position Summary. The company overview is about the company, not role. Could we add another section like "About the company"? Not in allowed headings. But we could incorporate into About the role? Might be okay to add a brief paragraph about company under About the role before Position Summary. The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid adding other content under those headings. So we can prepend company overview to About the role. Let's adjust About the role paragraph to include company overview then position summary. We'll combine: About the role: ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. ... (company overview). Then Position Summary. We'll keep as one