CMC Manager

Job Purpose: The position will be overseeing Chemistry, Manufacturing, and Controls (CMC) activities, ensuring the highest quality and compliance standards. Responsibilities will encompass a range of tasks, including technical writing, collaboration with manufacturing sites, and close coordination with Quality Assurance (QA) and Quality Control (QC)...

Job Purpose: The position will be overseeing Chemistry, Manufacturing, and Controls (CMC) activities, ensuring the highest quality and compliance standards. Responsibilities will encompass a range of tasks, including technical writing, collaboration with manufacturing sites, and close coordination with Quality Assurance (QA) and Quality Control (QC)...

MAIN RESPONSIBILITIES Provide technical support (internally and during meetings with prospects) and content for the preparation of proposals Represent the company in forums and conferences where he/she acts as an expert on a subject Prepare or review CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files). Define...

MAIN RESPONSIBILITIES Provide technical support (internally and during meetings with prospects) and content for the preparation of proposals Represent the company in forums and conferences where he/she acts as an expert on a subject Prepare or review CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files). ...

Description Collate and review CMC documents (i.e. Master Formula Card, PDR, BMR, BPR, Specifications, Validation reports etc.) from F&D, ADL, QA, production, packaging department and review of data for ANDA preparation, deficiency response, annual reports and supplements. Prepare and review the ANDA’s sections. Compile controlled...

Job Description: Role : Scientist  Reports to : Associate Director - CMC (Analytical) Location : Hyderabad, India Purpose of the Role : Work both as individual contributor and in collaboration with team to facilitate & drive timely achievement of CMC & R&D objectives, from CMC (Analytical) function. Qualification : Ph.D (preferred), M. Pharma/M.Sc in...

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Director, Chemistry Manufacturing and Controls (CMC) (Director, CMC) to join our A-team (hybrid*/remote). As a CMC Senior...

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Scientist, Chemistry Manufacturing and Controls (CMC) (Sr. Scientist, CMC) to join our A-team (hybrid*/remote). As a CMC...

Specific activities and responsibilities: Review the drug product dossier section ( specifically 3.2.P.2 and 3.2.P.3 ) as per the EU regulatory requirement. Aware of regulatory requirements, and technical knowledge of various pharmaceutical dosage forms. Project coordination and management skills CMC regulatory requirements for other than...

Specific activities and responsibilities: Review the drug product dossier section ( specifically 3.2.P.2 and 3.2.P.3 ) as per the EU regulatory requirement. Aware of regulatory requirements, and technical knowledge of various pharmaceutical dosage forms. Project coordination and management skills CMC regulatory requirements for other than...

Job Description Preferred qualifications are: • Experience in manufacture, quality or distribution in Pharmaceutical/Biotech industry • Strong oral and written communication skills in English and Spanish • Proficiency working with teams at different levels• Able to operate in a fast paced, dynamic environmentResponsibilities • Support site...

Job Description Preferred qualifications are: • Experience in manufacture, quality or distribution in Pharmaceutical/Biotech industry • Strong oral and written communication skills in English and Spanish • Proficiency working with teams at different levels• Able to operate in a fast paced, dynamic environmentResponsibilities • Support site...

Organisation : USV, a top -15 pharmaceutical company in India, excels in the diabetes and cardio sectors. With a presence in over 65 countries, our dynamic team of over 7,000 spans generations. Our commitment to brand building is evident in our popular products like Glycomet GP, Ecosprin AV, Jalra, Tazloc, Glynase and more. Responsibilities: For the CMC RA...

**Responsibilities**: 1. To promote and sell maintenance services a) To convert AMC (Annual Maintenance Contracts) to CMC (Comprehensive Annual Maintenance Contracts), b) Convert non-AMC, CR (Chargeable Repairs), Out of warranty instruments in AMC / CMC c) To promote PM kits (Preventive Maintenance Kits) to CR and AMC customers 2. To promote and sell...

**Responsibilities**: 1. To promote and sell maintenance services a) To convert AMC (Annual Maintenance Contracts) to CMC (Comprehensive Annual Maintenance Contracts), b) Convert non-AMC, CR (Chargeable Repairs), Out of warranty instruments in AMC / CMC c) To promote PM kits (Preventive Maintenance Kits) to CR and AMC customers 2. To promote and sell...

Job Description Sr. Associate Regulatory Affairs with experience in manufacture, quality, or distribution in Pharmaceutical or Biotech Industry.Responsibilities: Assist RA CMC Site Regulatory to support regulatory activities (e.g. Facility registrations, variations/supplements, country specific documents coordination).Provide and maintain CTA/MA...

Responsibilities:To promote and sell maintenance servicesa) To convert AMC (Annual Maintenance Contracts) to CMC (Comprehensive Annual Maintenance Contracts),b) Convert non-AMC, CR (Chargeable Repairs), Out of warranty instruments in AMC / CMCc) To promote PM kits (Preventive Maintenance Kits) to CR and AMC customersTo promote and sell Validation servicesa....

Description Collate and review CMC documents (i.e. Master Formula Card, PDR, BMR, BPR, Specifications, Validation reports etc.) from F&D, ADL, QA, production, packaging department and review of data for ANDA preparation, deficiency response, annual reports and supplements. Prepare and review the ANDA’s sections. Compile controlled...

Job Description Sr. Associate Regulatory Affairs with experience in manufacture, quality, or distribution in Pharmaceutical or Biotech Industry.Responsibilities: Assist RA CMC Site Regulatory to support regulatory activities (e.g. Facility registrations, variations/supplements, country specific documents coordination).Provide and maintain CTA/MA...

Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic...