Downstream Manufacturing Scientist

Position Summary
The Downstream Manufacturing Scientist is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars. The candidate will be responsible in the purification of 50L to 1000L volumes engineering, clinical and commercial batches in a cGMP environment. This position requires technical expertise in AKTA purification skids or similar, TFF and knowledge of initiating batch records, protocols, investigations and other technical documents.
Work in a team environment to execute batches and can work independently with minimum supervision. This position requires extensive technical expertise in mammalian cell-based purification processes, cGMP manufacturing and compliance for BLA requirements.

Essential Duties & Responsibilities

-Perform downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
-Provides technical direction in the execution and development of the purification process.
-Uses programs to collect and evaluate operating data to conduct on- line adjustments to products, instruments or equipment.
-Ensure that engineering and clinical batches are executed in a timely manner.
-Establishes operating equipment specifications and improves manufacturing techniques.
-Works with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment.
-Should follow GMP instructions in the manufacturing area and take the lead to follow environmental health and safety policies.
-Coordinate the conduction of investigations and corrections for issues found during the batch execution process.
-Performs other functions as required or assigned
-Complies with all company policies and standards

Position Requirements and Qualifications

Education:
-Requires a Bachelor or Master' degree in chemical, biological or biochemical sciences and a minimum of 4 - 5years of related experience in the biopharmaceutical industry.
-Previous experience working in GMP and aseptic manufacturing environment.
-Experience working with AKTA Process skids or similar and familiarity of single use manufacturing consumables such as bags, tube sets, columns and process manifolds.
-Possess knowledge to execute engineering and clinical batches; familiar with GMP documentation.

Special Skills:
-Ability to work with other team members and independently - good interpersonal skills.
-Good communication skills: verbal and written, good computer and organization skills, detail oriented.
-Basic computer skills, including knowledge of Word, Excel and spread sheet.
-Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
-Knowledgeable in cleaning verification/validation.
Employment Type: Contractor
Salary: $ 40.00 Per Hour