As part of the downstream processing department, protein scientists work on Antibody/Protein purification processes, protein modification/conjugation, and interface closely with Development, QA, Production, Operations, and Regulatory. The scope of this role will be to lead and manage protein conjugations to fluorescent molecules and/or DNA oligos for scale-ups in manufacturing, lead investigations of product failures and product improvements, as well as improvement and optimization of the manufacturing processes and equipment. Much of this cutting edge work goes into products for cancer research or infectious diseases (Like COVID19).
Working knowledge of:
- Process purification including Protein A, IEX, and SEC chromatography
- Antibody Conjugates to proteins or/and enzymes
- AKTA bioprocessing equipment experience such as the AKTA Prime purification systems and/or FPLC
- Filtration Experience
- Analytical testing using SDS-PAGE, endotoxin assay’s, western blots, etc.
- Drafting manufacturing, validation, risk assessments, and characterization documents in line with our ISO9001.2008 standards and customer requirements.
Other responsibilities include:
- Develop and implement process data monitoring and process maintenance.
- Experience in immunoassays such as ELISA and western blotting preferred.
- Maintain technical information and operational records.
- Work with Development, QA, Mfg floor to ensure SOP’s accuracy and usage.
- A bachelor’s degree in Chemical engineering, biochemistry, chemistry, or related field and 4+ years of experience.
- A masters’ degree in Chemical engineering, biochemistry, chemistry, or related field and 2+ years of experience optional.
- GMP and ISO Standard experience a minimum of 2 years’ experience.
- Validation, verification, and change control a minimum of 2 years’ experience.
- Knowledge of immunoassays is a plus.
- Strong interpersonal skills to succeed in a team environment
- Excellent written and oral skills are necessary.
- Ability to accomplish goals under project team timelines
- Exhibit strong attention to detail and documentation control.
- Able to work independently performing complex experiments with minimum supervision at times.