Analytical Development Supervisor
SAB BIO · Sioux Falls, SD · 1 mo ago
On-siteFull-time
We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections where there is real specific content. We must not repeat job title. Must not include Job ID etc. Must remove boilerplate like EEO, etc. Must preserve all substantive info.
We need to parse the posting.
Content:
- Intro paragraph: "The Analytical Development Supervisor within the ADQC department serves as an operational level member of management within the ADQC laboratory. This role focuses on driving day-to-day lab performance, ensuring consistent cGMP and regulatory compliance and data integrity standards. The role is responsible for executing analytical development activities supporting biologics programs from early phase to pivotal phase, regulatory submission, and commercialization. This role will lead method development, optimization, qualification, validation, method transfer to internal and external laboratories, method lifecycle management, and ensure analytical readiness to support CMC milestones and regulatory submissions. The incumbent must possess strong scientific judgment, hands-on laboratory expertise, and the ability to collaborate effectively with cross-functional teams and external partners in a highly regulated, fast-paced environment. Some relocation assistance is available for this role."
That's about the role.
Then "Duties and Responsibilities (Include but are not limited to):" followed by bullet-like sentences separated by line breaks? Actually they are concatenated with no bullet markers. We need to turn into
- items. We'll need to split by sentences? The content includes many responsibilities separated by line breaks? The text: "Lead and perform hands-on analytical work including method development, qualification, validation, transfer to internal and external QC labs, lifecycle management, and author associated documentation (method development reports, technical reports, qualification / validation reports, method SOP etc.)Ensure analytical readiness for late‑stage development, PPQ, and commercial launch of SAB-142 polyclonal antibody programLead and perform hands-on method troubleshooting, method optimization, method bridging, method performance monitoring, investigations (deviations, system suitability failure, OOT, OOS), CAPA, change control, continuous method improvement initiatives, and author associated documentationContribute to qualification and stability monitoring of reference standard, assay control, and critical reagents, qualification and testing of extended characterization assays, and forced degradation/stress sample studyEnsure analytical activities performed internally and at external partners are scientifically rigorous, comply with cGMP, ICH, USP, global regulations, and QbD principles, and align with industry’s best practices and company quality standardsContribute to specification setting, and regulatory submissionsManage general laboratory operations, equipment qualification & maintenance, support the scaling of analytical capabilities, establishment of analytical non-GMP development area, and implementing workflows and LIMSPartner closely with Quality Control and Quality Assurance to establish, maintain, and oversee analytical quality, GMP compliance infrastructure, and inspection readiness for internal and external analytical documents and dataOther duties/responsibilities as assigned"
We need to split into separate duties. Likely each sentence before a capital letter after a period? But there are no periods inside some sentences? Actually there are periods after some parentheses? Let's identify:
1. "Lead and perform hands-on analytical work including method development, qualification, validation, transfer to internal and external QC labs, lifecycle management, and author associated documentation (method development reports, technical reports, qualification / validation reports, method SOP etc.)"
2. "Ensure analytical readiness for late‑stage development, PPQ, and commercial launch of SAB-142 polyclonal antibody program"
3. "Lead and perform hands-on method troubleshooting, method optimization, method bridging, method performance monitoring, investigations (deviations, system suitability failure, OOT, OOS), CAPA, change control, continuous method improvement initiatives, and author associated documentation"
4. "Contribute to qualification and stability monitoring of reference standard, assay control, and critical reagents, qualification and testing of extended characterization assays, and forced degradation/stress sample study"
5. "Ensure analytical activities performed internally and at external partners are scientifically rigorous, comply with cGMP, ICH, USP, global regulations, and QbD principles, and align with industry’s best practices and company quality standards"
6. "Contribute to specification setting, and regulatory submissions"
7. "Manage general laboratory operations, equipment qualification & maintenance, support the scaling of analytical capabilities, establishment of analytical non-GMP development area, and implementing workflows and LIMS"
8. "Partner closely with Quality Control and Quality Assurance to establish, maintain, and oversee analytical quality, GMP compliance infrastructure, and inspection readiness for internal and external analytical documents and data"
9. "Other duties/responsibilities as assigned"
We'll make
- for each.
Then "Supervisory Responsibilities: This position does not supervise employees at the start. May supervise junior staff as the group expands. Will have indirect supervisory level responsibilities with external partner/CDMO partnerships, and relationships."
That could be part of Responsibilities or a separate section? Could be under Responsibilities. We'll include as part of Responsibilities.
Then "Education/Experience/Skills:" bullet list.
We need sections: Requirements, Qualifications, Skills. The posting lumps Education/Experience/Skills. We need to split into appropriate sections: Education/Experience (Requirements?), Qualifications maybe education, Skills maybe technical skills.
We must not invent sections with placeholder. We have content for Education, Experience, Skills.
We can create:
- Requirements: maybe Education and Experience (Bachelor's degree with 7+ years..., Master's degree highly desirable). Could be under Requirements.
- Qualifications: maybe deep hands-on expertise etc. Could be under Qualifications.
- Skills: maybe communication, Microsoft Office, etc.
But we need to ensure we don't create empty sections. We'll allocate content accordingly.
Let's extract:
Education/Experience:
"Bachelor's degree with 7+ years of progressively responsible and relevant experience in life sciences, Biophysics, Biochemistry or a related discipline in a biotech/pharma environment.. Master’s degree highly desirable"
That's education and experience.
Deep hands-on expertise in A280, HPLC, CE-SDS, cIEF, and LC-MS for biologics. Experience in ELISA, and cell-based potency methods is a plus. Strong understanding of method validation, method transfer, and applicable guidelines (ICH, FDA guidance documents, USP/EP chapters etc.) with deep expertise in cGMP requirementsExperience in reference standard program, critical reagent program, and forced degradation studyUtilizes established mathematical and scientific techniques including simple statistical analysis to compile and analyze data. Trend analysis /control charting is a plusStrong written and verbal communication and technical writing skills and the ability to effectively present information in one-on-one, small groups, and departmental/cross functional meetings. Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint and Outlook)
That's skills and qualifications.
We could treat:
- Requirements: Education and Experience (Bachelor's + 7+ years, Master's desirable)
- Qualifications: Deep hands-on expertise in techniques, understanding of method validation, experience in reference standard program, etc.
- Skills: Communication, technical writing, Microsoft Office, statistical analysis, trend analysis.
But we need to avoid duplication. Let's split:
Qualifications: Deep hands-on expertise in A280, HPLC, CE-SDS, cIEF, LC-MS for biologics. Experience in ELISA, and cell-based potency methods is a plus. Strong understanding of method validation, method transfer, and applicable guidelines (ICH, FDA guidance documents, USP/EP chapters etc.) with deep expertise in cGMP requirements. Experience in reference standard program, critical reagent program, and forced degradation study.
Skills: Utilizes established mathematical and scientific techniques including simple statistical analysis to compile and analyze data. Trend analysis /control charting is a plus. Strong written and verbal communication and technical writing skills and the ability to effectively present information in one-on-one, small groups, and departmental/cross functional meetings. Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint and Outlook).
That seems reasonable.
Now Benefits: "Some relocation assistance is available for this role." That's a benefit. Also maybe other benefits not mentioned. So we can include Benefits section with that.
Pay and Schedule: Not mentioned. So we should NOT include Pay or Schedule sections.
Now About the role: we have intro paragraph.
Now Responsibilities: we have duties list plus supervisory responsibilities.
Now we need to output HTML fragment with headings
for each section. We must not include job title heading. We must not include any boilerplate like EEO, ADA, etc. Remove those. We must not include Working Environment and Travel, Physical Requirements, ADA, etc. Those are boilerplate? They are not explicitly listed as boilerplate but they are generic. The instruction: "Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions." Working Environment and Travel, Physical Requirements, ADA might be considered boilerplate? Not sure. But they are not EEO etc. However they are generic. The instruction says to preserve ALL substantive information; do NOT invent or summarize away detail. So we should keep them if they are substantive. However they are fairly generic but still part of posting. The instruction didn't explicitly say to remove Working Environment etc. It only said remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we should keep Working Environment and Travel, Physical Requirements, ADA. However they might be considered boilerplate but not explicitly listed. Safer to keep them? The instruction: "Prefer a few substantive sections over many thin ones." Could combine them into a "Working Conditions" section? But we only have headings for specific list: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. No "Working Environment". So we cannot create a heading not in list. So we must either fold that content into existing sections or drop it. Since we cannot create a new heading, we need to decide where to put that info. 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? It says "use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." Likely they expect only those headings. So we must not add other headings. Therefore we need to incorporate Working Environment, Physical Requirements, ADA into existing sections, maybe under About the role or Responsibilities? Or we could drop them if they are not substantive? But they are substantive details about working conditions. The instruction says preserve ALL substantive information. So we need to include them somewhere. We could add a paragraph under About the role or Responsibilities. Probably under About the role we can add a sentence about working environment. Thus we will incorporate: "Duties will be performed in normal office, laboratory and BSL2 laboratory environments. Travel is not typical for this position. Ability to regularly move up to 10 pounds. Specific vision abilities required include close vision, peripheral vision, and ability to adjust focus. Employee will view a computer monitor for long periods of time. The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990." We can add that as a paragraph after the intro. Now Benefits: relocation assistance. Now we need to ensure we don't include duplicated lines. Now produce HTML. Structure:
About the role
... intro paragraph ...
... working environment paragraph ...
Responsibilities
- ... each duty ... ...
Requirements
Bachelor's degree with 7+ years of progressively responsible and relevant experience in life sciences, Biophysics, Biochemistry or a related discipline in a biotech/pharma environment. Master’s degree highly desirable.
Qualifications
- Deep hands-on expertise in A280, HPLC, CE-SDS, cIEF, and LC-MS for biologics.
- for each.
Then "Supervisory Responsibilities: This position does not supervise employees at the start. May supervise junior staff as the group expands. Will have indirect supervisory level responsibilities with external partner/CDMO partnerships, and relationships."
That could be part of Responsibilities or a separate section? Could be under Responsibilities. We'll include as part of Responsibilities.
Then "Education/Experience/Skills:" bullet list.
We need sections: Requirements, Qualifications, Skills. The posting lumps Education/Experience/Skills. We need to split into appropriate sections: Education/Experience (Requirements?), Qualifications maybe education, Skills maybe technical skills.
We must not invent sections with placeholder. We have content for Education, Experience, Skills.
We can create:
- Requirements: maybe Education and Experience (Bachelor's degree with 7+ years..., Master's degree highly desirable). Could be under Requirements.
- Qualifications: maybe deep hands-on expertise etc. Could be under Qualifications.
- Skills: maybe communication, Microsoft Office, etc.
But we need to ensure we don't create empty sections. We'll allocate content accordingly.
Let's extract:
Education/Experience:
"Bachelor's degree with 7+ years of progressively responsible and relevant experience in life sciences, Biophysics, Biochemistry or a related discipline in a biotech/pharma environment.. Master’s degree highly desirable"
That's education and experience.
Deep hands-on expertise in A280, HPLC, CE-SDS, cIEF, and LC-MS for biologics. Experience in ELISA, and cell-based potency methods is a plus. Strong understanding of method validation, method transfer, and applicable guidelines (ICH, FDA guidance documents, USP/EP chapters etc.) with deep expertise in cGMP requirementsExperience in reference standard program, critical reagent program, and forced degradation studyUtilizes established mathematical and scientific techniques including simple statistical analysis to compile and analyze data. Trend analysis /control charting is a plusStrong written and verbal communication and technical writing skills and the ability to effectively present information in one-on-one, small groups, and departmental/cross functional meetings. Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint and Outlook)
That's skills and qualifications.
We could treat:
- Requirements: Education and Experience (Bachelor's + 7+ years, Master's desirable)
- Qualifications: Deep hands-on expertise in techniques, understanding of method validation, experience in reference standard program, etc.
- Skills: Communication, technical writing, Microsoft Office, statistical analysis, trend analysis.
But we need to avoid duplication. Let's split:
Qualifications: Deep hands-on expertise in A280, HPLC, CE-SDS, cIEF, LC-MS for biologics. Experience in ELISA, and cell-based potency methods is a plus. Strong understanding of method validation, method transfer, and applicable guidelines (ICH, FDA guidance documents, USP/EP chapters etc.) with deep expertise in cGMP requirements. Experience in reference standard program, critical reagent program, and forced degradation study.
Skills: Utilizes established mathematical and scientific techniques including simple statistical analysis to compile and analyze data. Trend analysis /control charting is a plus. Strong written and verbal communication and technical writing skills and the ability to effectively present information in one-on-one, small groups, and departmental/cross functional meetings. Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint and Outlook).
That seems reasonable.
Now Benefits: "Some relocation assistance is available for this role." That's a benefit. Also maybe other benefits not mentioned. So we can include Benefits section with that.
Pay and Schedule: Not mentioned. So we should NOT include Pay or Schedule sections.
Now About the role: we have intro paragraph.
Now Responsibilities: we have duties list plus supervisory responsibilities.
Now we need to output HTML fragment with headings
Similar jobs
Head of Analytical Development
Business Development$272k–$490k/yrapply on modernatx.wd1.myworkdayjobs.com
Advisor - Analytical Development
OTHR$138k–$202k/yrapply on jobs.biospace.com
Advisor - Analytical Development
OTHR$138k–$202k/yrapply on careers.lilly.com
Pre-Analytical Supervisor
Managementapply on veracyte.com
Pre-Analytical Supervisor
Managementapply on careers.stcharleshealthcare.org
Pre-Analytical Supervisor
Managementapply on careers.stcharleshealthcare.org