... IMPD authoring and readiness, and agency interaction activities, in preparation for commercialization and incremental clinical/commercial batch production of our main asset. This role will focus on ...
... IMPD authoring and readiness, and agency interaction activities, in preparation for commercialization and incremental clinical/commercial batch production of our main asset. This role will focus on ...
Serve as the primary GMP quality lead for CMC regulatory submissions, including IND, IMPD, BLA/MAA modules and ensure all CMC documentation are accurate. * Supervise and guide internal audits of ...
Serve as the primary GMP quality lead for CMC regulatory submissions, including IND, IMPD, BLA/MAA modules and ensure all CMC documentation are accurate. * Supervise and guide internal audits of ...
Senior Manager, Drug Product
Cambridge, MA ยท On-site
$122K - $174K/yr
You will contribute to completion (author/review) of relevant drug product sections of regulatory submission documents (IND, IMPD, NDA, briefing packages etc.), responses to regulatory questions and ...
Senior Manager, Drug Product
Cambridge, MA ยท On-site
$122K - $174K/yr
You will contribute to completion (author/review) of relevant drug product sections of regulatory submission documents (IND, IMPD, NDA, briefing packages etc.), responses to regulatory questions and ...
Knowledge of global CMC regulatory submission requirements including submission formats (eCTD for IND, IMPD, NDA, MAAs and NEES). Department lead on the clinical and commercial CMC submission ...
Knowledge of global CMC regulatory submission requirements including submission formats (eCTD for IND, IMPD, NDA, MAAs and NEES). Department lead on the clinical and commercial CMC submission ...
Author and review drug product sections for regulatory submissions, including original IND/IMPD, IND/IMPD amendments, BLA, and response to queries from global regulatory authorities, Investigator ...
Author and review drug product sections for regulatory submissions, including original IND/IMPD, IND/IMPD amendments, BLA, and response to queries from global regulatory authorities, Investigator ...
This deputy prosecutor will work closely with the joint IMPD/DEA fatal overdose task force to build successful cases. Agency Summary The Marion County Prosecutor's Office, led by Prosecutor Ryan ...
This deputy prosecutor will work closely with the joint IMPD/DEA fatal overdose task force to build successful cases. Agency Summary The Marion County Prosecutor's Office, led by Prosecutor Ryan ...
Scientist, Biologics CMC Analytical Development
Foster City, CA ยท On-site
$146K - $189K/yr
Proven experience leading early-stage CMC analytical programs, supporting pre-pivotal development (Toxicology, Phase I/II) and regulatory submissions (IND/IMPD). * Strong experience in analytical ...
Scientist, Biologics CMC Analytical Development
Foster City, CA ยท On-site
$146K - $189K/yr
Proven experience leading early-stage CMC analytical programs, supporting pre-pivotal development (Toxicology, Phase I/II) and regulatory submissions (IND/IMPD). * Strong experience in analytical ...
Scientist, Biologics CMC Analytical Development
Foster City, CA ยท On-site
$146K - $189K/yr
Contribute to Regulatory and Scientific Deliverables Present findings to senior leadership, author technicalreportsand manuscripts, and support regulatory submissions ( e.g., IND/IMPD/CTA) and ...
Scientist, Biologics CMC Analytical Development
Foster City, CA ยท On-site
$146K - $189K/yr
Contribute to Regulatory and Scientific Deliverables Present findings to senior leadership, author technicalreportsand manuscripts, and support regulatory submissions ( e.g., IND/IMPD/CTA) and ...
Regulatory CMC Director (Cell & Gene Therapy)
Gaithersburg, MD ยท Hybrid
$162K - $213K/yr
Partner with stakeholders to deliver CMC components of IND, IMPD, BLA, Master Files, amendments, and annual reports; develop health authority briefing documents; represent CMC regulatory affairs on ...
Regulatory CMC Director (Cell & Gene Therapy)
Gaithersburg, MD ยท Hybrid
$162K - $213K/yr
Partner with stakeholders to deliver CMC components of IND, IMPD, BLA, Master Files, amendments, and annual reports; develop health authority briefing documents; represent CMC regulatory affairs on ...
Regulatory CMC Director (Cell & Gene Therapy)
Gaithersburg, MD ยท On-site
$162K - $213K/yr
Partner with stakeholders to deliver CMC components of IND, IMPD, BLA, Master Files, amendments, and annual reports; develop health authority briefing documents; represent CMC regulatory affairs on ...
Regulatory CMC Director (Cell & Gene Therapy)
Gaithersburg, MD ยท On-site
$162K - $213K/yr
Partner with stakeholders to deliver CMC components of IND, IMPD, BLA, Master Files, amendments, and annual reports; develop health authority briefing documents; represent CMC regulatory affairs on ...
Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and ...
Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and ...
Author and review drug product sections for regulatory submissions, including original IND/IMPD, IND/IMPD amendments, BLA, and response to queries from global regulatory authorities, Investigator ...
Author and review drug product sections for regulatory submissions, including original IND/IMPD, IND/IMPD amendments, BLA, and response to queries from global regulatory authorities, Investigator ...
Experience in CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM). * Solid knowledge of US and international GMP quality regulations, current industry practices, and ...
Experience in CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM). * Solid knowledge of US and international GMP quality regulations, current industry practices, and ...
IND/IMPD and BLA/MAA Module 3 authorship experience and Continuous Process Verification planning and execution highly preferred * Data Analytics experience including JMP and other data organization ...
IND/IMPD and BLA/MAA Module 3 authorship experience and Continuous Process Verification planning and execution highly preferred * Data Analytics experience including JMP and other data organization ...
CRDMO Program Lead
$175K - $215K/yr
Experience supporting IP, IND, BLA, MAA, or IMPD submissions. * Demonstrated experience leading programs in an IPD, alliance management, or co-development model; CRDMO/sponsor partnership experience ...
CRDMO Program Lead
$175K - $215K/yr
Experience supporting IP, IND, BLA, MAA, or IMPD submissions. * Demonstrated experience leading programs in an IPD, alliance management, or co-development model; CRDMO/sponsor partnership experience ...
CMC Writer
Paramus, NJ ยท On-site
Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions * Ensure completion ...
Quick apply
CMC Writer
Paramus, NJ ยท On-site
Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions * Ensure completion ...
Associate Director, Process Chemistry (Remote)
San Diego, CA ยท On-site
$170K - $210K/yr
Author assigned CMC sections to support regulatory filings (such as IND, IMPD, NDA, MAA) and respond to questions from regulatory agencies * Serve as drug substance SME for cross-functional project ...
Quick apply
Associate Director, Process Chemistry (Remote)
San Diego, CA ยท On-site
$170K - $210K/yr
Author assigned CMC sections to support regulatory filings (such as IND, IMPD, NDA, MAA) and respond to questions from regulatory agencies * Serve as drug substance SME for cross-functional project ...
Senior Manager, Drug Product
Cambridge, MA ยท On-site
$122K - $174K/yr
You will contribute to completion (author/review) of relevant drug product sections of regulatory submission documents (IND, IMPD, NDA, briefing packages etc.), responses to regulatory questions and ...
Senior Manager, Drug Product
Cambridge, MA ยท On-site
$122K - $174K/yr
You will contribute to completion (author/review) of relevant drug product sections of regulatory submission documents (IND, IMPD, NDA, briefing packages etc.), responses to regulatory questions and ...
CRDMO Program Lead
Alameda, CA ยท On-site
$175K - $215K/yr
Experience supporting IP, IND, BLA, MAA, or IMPD submissions. * Demonstrated experience leading programs in an IPD, alliance management, or co-development model; CRDMO/sponsor partnership experience ...
CRDMO Program Lead
Alameda, CA ยท On-site
$175K - $215K/yr
Experience supporting IP, IND, BLA, MAA, or IMPD submissions. * Demonstrated experience leading programs in an IPD, alliance management, or co-development model; CRDMO/sponsor partnership experience ...
... g., IND / IMPD / CTN, NDA) Identify issues and propose solutions. Proactively assess potential risks to the clinical study and propose mitigation plans Work in an office (Wilmette, IL north of ...
... g., IND / IMPD / CTN, NDA) Identify issues and propose solutions. Proactively assess potential risks to the clinical study and propose mitigation plans Work in an office (Wilmette, IL north of ...
Impd information
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$5.1K is the 25th percentile. Wages below this are outliers.
$4.3K - $6.7K
73% of jobs
$7K is the 75th percentile. Wages above this are outliers.
$6.7K - $9.2K
14% of jobs
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6% of jobs
$28.8K - $31.3K
6% of jobs
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How much do impd jobs pay per month?
What are the key skills and qualifications needed to thrive as an IMPD (Indianapolis Metropolitan Police Department) officer, and why are they important?
What is the difference between Impd vs Data Analyst?
| Aspect | Impd | Data Analyst |
|---|---|---|
| Required Credentials | Typically requires a degree in engineering, manufacturing, or related fields; certifications like Six Sigma or Lean are common | Requires a degree in statistics, mathematics, or computer science; certifications like CAP or Microsoft Data Analyst are beneficial |
| Work Environment | Primarily in manufacturing or industrial settings, focusing on process improvement and quality control | Mostly in office settings, analyzing data, creating reports, and supporting decision-making |
| Employer & Industry Usage | Used in manufacturing, production, and industrial sectors for process optimization | Used across various industries including finance, healthcare, marketing, and technology for data analysis |
While Impd professionals focus on process improvement within manufacturing environments, Data Analysts interpret data to support business decisions across multiple industries. Both roles require analytical skills but differ in their specific applications and work settings.
What are IMPD officers?
What are some common challenges faced by IMPD officers during their daily patrols?

Senior Principal Engineer/Associate Director, Drug Product MSAT
Summit TherapeuticsPrinceton, NJ โข On-site
Other
Posted 11 days ago
Job description
Overview of Role:
We are seeking a highly experienced and strategic Senior Principal Engineer/Associate Director of MSAT - Drug Product to join the CMC team and be a key contributor to ongoing process development, technology transfer, process validation, BLA/MAA/IND/IMPD authoring and readiness, and agency interaction activities, in preparation for commercialization and incremental clinical/commercial batch production of our main asset. This role will focus on leading DP Tech transfer(s), authoring technical reports and on providing content to the CMC chapters of regulatory submitted documents, ensuring all required data integrity and technical compliance standards are met. The ideal candidate will bring significant experience in biologics manufacturing, sterile drug product operations, and regulatory expectations.ย ย
Role and Responsibilities:
- Provide technicalย expertiseย forย phase-appropriateย drug productย process development, characterization,ย validation, and technology transfer forย sterileย drugย productย (DP).ย
- Assess and manage process risks arising from manufacturing or process changes.ย
- Serve as a primaryย or supportingย technical interface with external CDMOs and internal manufacturing teams.ย ย
- Lead or significantly contribute to implementation of process, product, and site changes across the product lifecycle.ย ย
- Support and guide execution of clinical and commercial batch manufacturing activities to meet development and supply timelines.ย ย
- Assistย in the authorship,ย data verification,ย update, and/or review of regulatory filings.ย
- Provide technical feedback during regulatory agency inquiries.ย ย
- Lead PPQ execution and manufacturing oversight in alignment with GMP and quality system requirements through person in plant.ย ย
- Collaborate closely with Regulatory, Quality, Supply Chain, and other CMC functions to ensure integrated planning and execution.ย ย
- Ensure GMP compliance across all assigned activities.ย ย
- Support audits, inspections, and continuous improvement initiatives.ย ย
- Manage process deviation investigations and change controls.ย
- Travelย asย needed to support technology transfer, process scale-up, and collaboration with external partners.ย
- All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
- Bachelor'sย degreeย in chemical engineering, biotechnology, pharmaceutical science, orย a relatedย fieldย required.ย Advanced degree (Mastersย or PhD) preferred.ย
- Minimum ofย 10+ years of relevant experienceย within the life sciences industryย ย
- Demonstrated experience in process development, MSAT (Manufacturing Science and Technology), and/or manufacturingย with a focus on sterile drugย productย and late-phase developmentย (preferablyย mAbs)is essential.ย ย
- Experience with technology transfer across different systems, scales, and sites is highly valuedย
- Experience in late-stage process development, characterization and validation is highly valuedย
- IND/IMPD and BLA/MAA Module 3 authorship experience and Continuous Process Verification planning and execution highly preferredย
- Data Analytics experience including JMP and other data organization (AI-based or not)ย platforms a strong plusย
- Strong communication, management, and interpersonal skills to effectively influence across the organization and with CDMOs/CMOs.ย
- Excellent attention to detail and organizational skills, with a focus on quality and technical excellence.ย
- Good informationย management and data organization skillsย
- Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.ย
- A track recordย of working under pressure and delivering high-quality results to tight deadlines.ย