Nafi Anwar

• As Multidisciplinary Project Manager, I am responsible for Oral Pack Extension project in building DF, where the building is build from scratch from inside for the new lines. The project is very complex due to that the project is executed while the production continues. This project was close to be completed. Unfortunately, I was among the 5000 employees that was layed off in September, due to re-organization in NovoNordisk.

Novo Nordisk, 01Aug2023- 31Dec2023,

I was hired as interim senior project manager for Oral Pack Extension project in building DF.

Novo Nordisk , 01Aug2022- 01Aug 2023,

As Multidisciplinary Project Manager, I helped Biotech & Rare Disease building FF in Kalundborg with upgrading the Personal Air lock, Material Air lock and Waste Air lock according to Annex 1. This project was a very complex project with many sub-projects as dismantling and installing of HVAC channels, Sewer, and clean room.

Novo Nordisk , 01Mar2021-31Jul2022,

I helped IM1-Recovery in Kalundborg with production support in ML1 and ML2 as specialist. I managed also to be Project Manager for a couple of upgrades in the centrifuge room.

Novo Nordisk, 15Sep2020-28Feb20121:

I helped 2H in Bagsværd with writing different deviations reports for aseptic department.

Fujifilm Diosynth Biotechnologies, 01Jan2020-30Jun2020:

I helped in the Finish Goods Manufacturing area and supply Chain with optimizing of the workflow in a GMP production environment. I was also responsible for finalizing CAPA’s, SOP’s, working instructions, Change Requests and deviations.

Bavarian Nordic, 01Jun2017- 01Oct2019:

As Project Manager I helped with purchasing, installing, qualifying and validating a centrifuge and two Ultrasonicators for aseptic production for a new developed process. I helped with qualification of 6 bio-wave reactors. I helped with writing Periodic System Evaluation (PSE) for all equipment in aseptic production. I Helped composing a data sheet for all qualified parameters for all equipment in aseptic production. I Helped with writing CR, DR and production SOPs. I helped with several Equipment Qualification Rationales (EQR) for aseptic production for several product campaigns.

Leo Pharma, Ballerup, 01Oct2016-31May2017 :

I helped with establishment of new production and filling line. I was responsible for URS, RS, FAT, SAT, IQ, OQ and PQ.
I optimized the process in Recovery department, which resulted in a gain of the production from ca. 60 to ca. 68 %.

Novo Nordisk, 1S pilot plant , 01Apr2016-01Sep2016 :

I helped at Novo Nordisk, Bagsværd pilot plants, with writing PSE's (Periodic System Evaluation, VSS-reports (validation Status Summary).

Statens Serum Institute (SSI) , 01Jan2015-01Apr2016:

I helped in aseptic section as Chemist with batch release for production of disposable syringes with Sterile Water for Novo Nordisk.

• Company Overview: Dankur (http://www.dankur.com) is a Danish company that produces high quality natural cosmetic products for adults and children.
• After I had established the company and developed all products incl. labeling and packaging, my role as a Consultant Responsible Person has been to evaluate safety and classify all the ingredients in the products for Product Information File (PIF).
• Dankur (http://www.dankur.com) is a Danish company that produces high quality natural cosmetic products for adults and children.

• Worked as Technical Project Manager in R&D department where I was both responsible for building a Nicotine chewing gum pharma plant in DK for Gumlinks A/S customers in USA and also responsible for building an E-liquid plant including labelling and filling plant in DK. For both project I managed to prepare the necessary documentation for submission to the Danish Medicines Agency.

• I managed the following projects: Building a pilot plant for Torrefaction process with filling and packaging plant. The torrefaction plant was the first kind in the world. Building solid biofuel Plant in Poland, Bulgaria, Vietnam and animal feed in Russia, Ukraine and Mexico. The mentioned plant included also filling and packaging section. Building a Miscanthus pellet Plant for DRAX power ltd in UK, which is also the first plant in the world. Establishing a Change Request system for the company. For all above-mentioned customer projects, HAZOP was a standard part of the work.

• In January 2010, I decided to start my own production plant. I managed to design the organization and the basic design for the production plant, I also managed to find buyers for my products, but because of the global economy crises and problems with finding investors, I decided to stop the production plant.

• Besides having the responsibility for the quality and delivery of Human Insulin (HI) and Insulin Aspart (IA) I have been working with the following different fields: Being part of the process support / chemist-team which was engaged to build the biggest Insulin Bulk plant in the world. Process support /operation support, working with HPLC on production scale, hydrolyses, centrifugation and crystallization/ iso-precipitation processes. Reviewing batch reports for HPLC, hydrolysis, centrifugation and crystallization/ Iso-precipitation processes. Being part of educational task force for teaching new colleagues about process, insulin chemistry, GMP and diabetes. Writing and reviewing Validation and qualification protocols and reports (FAT, SAT, IQ, OQ, PQ and PV) of different process in purification and recovery steps. Handling the inspection from FDA, EMA and the Danish health and medicines authorities and customers. Being part of the task force for selection and job interview of new employee. Being super user of Statistical Process Control (SPC) and implementing SPC for Purification department and laboratory. Participating in implementation of LEAN. Being responsible for various strategically optimization projects, as: Automatizing the pH measurement with LMES-system in purification part for Human Insulin and Insulin Aspart. Optimization of the stationary phase (gel phase) of production scale HPLC, so it could have a longer shelf life. Hydrolysis optimization for which the doubled volume could be produced in the same container as before. For all above projects I managed to write change request (CR), PQP, PQR, PVP, PVR and different SOPs for use after the implementation. Organizing and participating in a teambuilding seminar for operators. Responsible for implementation of Process Analytical Technology (PAT) in purification. Coordinate the implementation of Product Protection Control Strategy (PPCS) in Purification for Human Insulin and Insulin Aspart. Writing Annual Product Review (APR) for purification for both Insulin and Insulin Aspart. Reporting Periodic System Evaluation (PSE) for both Insulin and Insulin Aspart. Being elected as work environmental, health and safety representative for all employees during the construction of Insulin Bulk plant in Kalundborg-Denmark. Reporting Lifetime of Column Matrices in Purification for both Human insulin and Insulin Aspart.