Contribute significant strategic direction and authorship of regulatory documents including clinical IND/IMPD and commercial BLA/MAA * Assess and manage process risks arising from manufacturing or ...
Contribute significant strategic direction and authorship of regulatory documents including clinical IND/IMPD and commercial BLA/MAA * Assess and manage process risks arising from manufacturing or ...
CMC Writer
Paramus, NJ · 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 ...
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CMC Writer
Paramus, NJ · 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 ...
Plan, prepare, and review CMC sections of regulatory submissions (IMPD/IND/ /MAA/NDA, post-approval variations). Determine regulatory CMC content and scientific/technical requirements to ensure ...
Plan, prepare, and review CMC sections of regulatory submissions (IMPD/IND/ /MAA/NDA, post-approval variations). Determine regulatory CMC content and scientific/technical requirements to ensure ...
Author and review regulatory submissions (IND/IMPD/BLA/MAA Module 3 sections) and provide technical support for health authority interactions. * Oversee PPQ execution and commercial manufacturing ...
Author and review regulatory submissions (IND/IMPD/BLA/MAA Module 3 sections) and provide technical support for health authority interactions. * Oversee PPQ execution and commercial manufacturing ...
Scientist, Biologics CMC Analytical Development
$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
$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 ...
The role will play a critical role in global regulatory filings (IND, IMPD, etc.) by authoring and reviewing key Module 3 sections. This role is based in Waltham, MA and requires regular onsite ...
The role will play a critical role in global regulatory filings (IND, IMPD, etc.) by authoring and reviewing key Module 3 sections. This role is based in Waltham, MA and requires regular onsite ...
Regulatory CMC Director (Cell & Gene Therapy)
Gaithersburg, MD · 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 · 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 ...
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 ...
Senior Manager, Drug Product
Cambridge, MA · 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 · 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 ...
Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.). Qualifications * BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent ...
Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.). Qualifications * BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent ...
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 ...
The role will play a critical role in global regulatory filings (IND, IMPD, etc.) by authoring and reviewing key Module 3 sections. This role is based in Waltham, MA and requires regular onsite ...
The role will play a critical role in global regulatory filings (IND, IMPD, etc.) by authoring and reviewing key Module 3 sections. This role is based in Waltham, MA and requires regular onsite ...
Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.). Qualifications * BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent ...
Quick apply
Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.). Qualifications * BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent ...
Senior Director/ Director, CMC Regulatory Affairs
South San Francisco, CA · On-site
$250K - $300K/yr
Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.). Qualifications * BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent ...
Senior Director/ Director, CMC Regulatory Affairs
South San Francisco, CA · On-site
$250K - $300K/yr
Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.). Qualifications * BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent ...
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 ...
Associate Director, Clinical Pharmacology
$185K - $215K/yr
Contribute to the preparation of the IND, IB and IMPD documents * Be able to conduct noncompartmental PK analysis based on preliminary data using standard industry data analysis software * Contribute ...
Associate Director, Clinical Pharmacology
$185K - $215K/yr
Contribute to the preparation of the IND, IB and IMPD documents * Be able to conduct noncompartmental PK analysis based on preliminary data using standard industry data analysis software * Contribute ...
Support CMC regulatory submissions by reviewing or contributing to relevant IND/IMPD Module 3 sections. Work closely with Quality Assurance and Regulatory Affairs to ensure CMC documentation, batch ...
Support CMC regulatory submissions by reviewing or contributing to relevant IND/IMPD Module 3 sections. Work closely with Quality Assurance and Regulatory Affairs to ensure CMC documentation, batch ...
Senior Manager / Associate Director, Process Development
South San Francisco, CA · On-site
$160K - $200K/yr
Support review of deviations, investigations, CAPAs, change controls, and root-cause analyses. • Support CMC regulatory submissions by reviewing or contributing to relevant IND/IMPD Module 3 ...
Senior Manager / Associate Director, Process Development
South San Francisco, CA · On-site
$160K - $200K/yr
Support review of deviations, investigations, CAPAs, change controls, and root-cause analyses. • Support CMC regulatory submissions by reviewing or contributing to relevant IND/IMPD Module 3 ...
Regulatory CMC Director (Cell & Gene Therapy)
Gaithersburg, MD · 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 · 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 ...
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| 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.
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Other
Posted 14 days ago
Job description
Location: Princeton, NJ (ONSITE)
Overview of Role:
The Sr Manager/Assoc Director, MSAT, is an experienced and enthusiastic process development scientist or engineer who will join a dynamic late-stage clinical and commercial environment working with our lead asset, Ivonescimab. The ideal candidate will have proven technical ability, commercial control strategy authorship, and module 3 BLA/MAA authorship experience specifically supporting biologics drug substance. The role involves working with the Summit MSAT group and other CMC, quality, and regulatory stakeholders in drug substance to provide operational, strategic, and technical oversight on predominantly downstream-related activities across the organization to achieve Summit milestones. This position will require building operational relationships with Summit CDMOs and working in close collaboration internally and externally to ensure successful CMC deliverables.
Role and Responsibilities:
- Contribute to and have accountability for all Summit Downstream CMC activities, focusing on control strategy development, process validation, continued process verification, and technical troubleshooting to support drug substance and product (as needed)
- Support phase-appropriate downstream process development, characterization, validation, and technology transfers to or between external CDMOs for drug substance (DS).
- Contribute significant strategic direction and authorship of regulatory documents including clinical IND/IMPD and commercial BLA/MAA
- Assess and manage process risks arising from manufacturing or process changes.
- Develop effective working relationships with Summit project team members and external Contract Manufacturing Organizations (CMOs).
- Support MSAT team objectives while providing clear and concise updates of results and reports to the project team leaders, including the Head of CMC.
- Work in close partnership with process scientists & engineers, QA, RA, supply chain, consultants, and cross-functionally.
- Support CMC sub-teams and programs.
- Facilitate problem-solving, contingency planning, and decision-making.
- Provide technical support to manufacturing operations, addressing and resolving any issues that arise during downstream processing.
- Drive continuous improvement to enhance process robustness, efficiency, and scalability.
- Oversee tech transfer activities to ensure a seamless transition from development to manufacturing.
- Manage process deviation investigations and change controls.
- Travel as needed to support technology transfer, process scale-up, and collaboration with external partners.
- Perform all other duties as assigned.
Educational Background:
- Degree in chemical engineering, biotechnology, pharmaceutical science, or a related field. Bachelor's degree with 12+ years of relevant experience; Master's degree with 10+ years of relevant experience; PhD with 8+ years of relevant experience.
Professional Experience:
- Demonstrated experience in process development, MSAT (Manufacturing Science and Technology), and/or manufacturing in a biological environment (preferably mAbs) is essential. IND/IMPD and BLA/MAA Module 3 authorship experience and Continuous Process Verification planning and execution is critical
- Experience with health authority inspection and information request responses highly desired
- Proven technical knowledge in various systems (e.g. Unicorn, Delta V, etc) and demonstrated proficiency in all downstream-related operations, including but not limited to Affinity (Protein A), Ion Exchange, Mixed-Mode, and Hydrophobic Interaction Chromatography, Virus Filtration, and Ultrafiltration / Diafiltration
- Proven track record with process scale-up and technology transfer, moving from bench scale to pilot and production plant
- Experience with technology transfer across different systems, scales, and sites is highly valued
- Experience in late-stage process development, characterization and validation is highly valued
Skills and Competencies:
- Data Analytics experience including JMP and other data organization (AI-based or not) platforms a strong plus
- Strong communication, management, and interpersonal skills to effectively influence across the organization and with CDMOs/CMOs.
- Excellent attention to detail and organizational skills, with a focus on quality and technical excellence.
- Good information management and data organization skills
- Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
- A track record of working under pressure and delivering high-quality results to tight deadlines.