Responsible for the technical and regulatory assessment of documentation (DMF – Drug Master File) and for prospecting/sourcing manufacturers of active pharmaceutical ingredients (APIs);
Responsible for Nitrosamine risk assessment for APIs and finished products;
Responsible for evaluation of API impurity profiles;
Contact and negotiation with national and international API manufacturers and suppliers;
Responsible for monitoring and meeting project targets for projects under development, as well as providing support to the team and interfacing departments;
Initiating purchase requests, tracking and approving sample shipments;
Preparation/review of SOPs (Standard Operating Procedures);
Responding to ANVISA requirements and audits.

Education: Bachelor's degree in Chemistry, Pharmacy and/or Chemical Engineering;
Postgraduate degree, Master’s and/or PhD in Organic Chemistry preferred;
Advanced/Fluent English;
Required knowledge of ANVISA regulations (including the Regulatory Framework for APIs: DIFA / CADIFA), as well as international guidance (ICH, AOAC, WHO, EMA, FDA, Health Canada, among others) related to active pharmaceutical ingredients and drug registration/post-registration;
Required experience in development, forced degradation, stability studies and analytical validation of APIs;
Required knowledge of API synthesis and evaluation of impurity profiles (elemental, inorganic, organic, genotoxic, nitrosamines, synthetic and/or degradation impurities), including in silico assessment.

Medical insurance;
Dental insurance;
Meal allowance;
On-site cafeteria;
Transportation allowance/shuttle/parking – depending on work location;
Pharmacy/dispensary with free medications for you, your parents, spouse and children;
Life insurance;
Private pension plan to help you plan your future;
Have children? You will be entitled to daycare (depending on work location);
Beauty salon so you can take care of yourself;
Gym to look after your health;
Short Friday to enjoy the day as you wish (6-hour workday for employees not working shifts);
Development programs offering partnerships with educational institutions at a discount;
Maternity leave;
Extended paternity leave.

Senior Technical Documentation Analyst – R&D, DMF

Key skills