The Bioprocess Engineering (BPE) department (within Research and Development) is responsible for scale up, technology transfer, and facility fit of clinical and commercial processes to manufacturing. Members of the BPE purification team work closely with development (located in the US and UK), manufacturing groups across all stages of purification process development (from Toxicology lot production through production of lots to support BLA filings), and engineering (on capital improvement projects). This position is within the purification scale up team responsible for producing development drug substance material and analyzing data from pilot facilities.Scale-up and evaluate purification processes at the 50L to 250L scale, and produce materials to supply development, viral clearance and non-clinical safety studies. Prepare large volume buffers, and operate chromatography and filtration equipment. Review, trend, analyze and present purification data at internal meetings to cross-functional teams. Identify, evaluate and implement emerging technologies and provide input on continuous process improvement. Perform lab-scale experiments to support process development investigations, and fit to plant challenges. Stay current with industry trends and vendor product development. Occasionally support non-clinical supply process to facilitate shipment of materials to contract research organizations.
This position can be filled at either the Research Associate II level or the Associate Scientist I level.
The Research Associate II level requires a Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, Biology or related field with 2 to 5 years of combined industry related process development, manufacturing, or related field.
The Associate Scientist I level requires a Bachelor's degree with 5-8 years of experience, or a Master's degree and 2-5 years of experience of combined industry experience related to process development, manufacturing or related field is preferred.
In addition, both levels require the following:
* Good interpersonal skills and ability to interact effectively with functional group members, project teams, manufacturing personnel, and suppliers is essential.
* Strong knowledge of purification unit operations such as chromatography, viral filtration, and ultrafiltration/diafiltration is desired.
* Basic knowledge of cGMP and CMC regulatory requirements is a plus.
* Must be able to function in a fast-paced environment, multi-task and handle shifting priorities.
* Ability to work in a fast paced, dynamic work environment is a must. S
* An understanding of purification unit operations, experimental design, and general laboratory techniques and instrumentation.
* The candidate should possess strong problem solving, organizational, and documentation skills with a focus on details and results.
* The candidate should be able to work independently as well as in a team environment.
* The candidate should be self-motivated and possess good interpersonal, collaborative, and communication skills.