I am a Process Engineer on the Technical Services team. Our team supports technology transfer of new products into the manufacturing site. We collaborate with the formulation scientists in FDL, external clients, and the manufacturing team to develop robust manufacturing processes to on-board these new products. We support the drug product through all phases of clinical trials to process validation and commercial launch, monitoring the manufacturing process to ensure success. This support includes primary authorship of documents such as batch records, risk assessments, engineering protocols and reports, validation protocols reports, and development reports.
What is the most rewarding part of your job?
The most rewarding aspect of my job is having the opportunity to transfer and develop manufacturing processes for drugs that are new and innovative. A large portion of my work is supporting products that are destined for clinical trials and in all phases of development. Knowing that each successful transfer represents a group of patients that will have the opportunity to undergo a new treatment highlights the importance of the work we do here at Alcami. Being part of the team that can offer that opportunity to patients is very rewarding.
What are your team’s latest achievements?
In the last year, our team has validated the manufacturing process for numerous New Drug Applications (NDAs) and Biologics Licenses Applications (BLAs), Breakthrough (BT) Drug Designations, and Orphan Drug Designations. These validations will lead to the commercial launch of drugs for indications that previously had no treatment. Successes like these illustrate our dedication to our clients and, ultimately, the patients who depend on the drugs we manufacture.
How do you see those accomplishments affecting the pharmaceutical and biotech industries?
The validations of these NDAs, BLAs, BT Drugs, and Orphan Drugs are critical to the industry as they continually improve the availability of treatments on the market. More importantly, the successful launch of new and innovative treatments provide therapeutic options to patients who previously had no treatment. As Alcami continues to establish itself as a leading contract development and manufacturing organization (CDMO), the successful launch of our clients’ products will be seen across the industry.