Scientist III, Analytical Development, Biologics CMC

SUMMARY/JOB PURPOSE:

The Scientist III, Analytical Development, Biologics CMC will independently conduct laboratory experiments with limited supervision to build in-house R&D testing capabilities in support of CMC analytical development projects for multiple types of biologics, including but not limited to monoclonal antibodies (mAb), bispecifics (BsAb) and antibody-drug conjugates (ADCs). The incumbent will utilize their technical expertise in analytical areas such as ELISA, cell-based assays, liquid chromatography (e.g. SEC, RP, HIC, IEC and etc..) and capillary electrophoresis (e.g. CE-SDS and icIEF) to execute method development and product characterization. The incumbent is expected to work in the laboratory full time, including operating state-of-art analytical equipment, responsible for routine instrument maintenance, and providing training to peers. The incumbent is also expected to effectively document lab results and draft test methods/SOPs in accordance with company, departmental, and regulatory guidelines.

Strong ownership is critical to ensure the speed, cost-effectiveness, and technical quality of our CMC activities. The individual selected will also need to work collaboratively with peers in an open well-equipped analytical lab.

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Execute and develop ELISA based activity methods for ADCs and mAb products.
• Execute and develop cell-based potency assays for ADCs and mAb products.
• Execute and develop HPLC methods, CE-SDS, icIEF, endotoxin, residual HCP, etc., as needed.
• Maintain complete and accurate records of laboratory work in conformance with company standard operating procedures (SOPs) and training.
• Provide detailed reviews of peer generated data as well as that generated from contracted service providers.
• Maintain the inventory of laboratory consumables and compliance to EHS standard.
• Coordinate vendors service calls for repair and maintenance of laboratory instruments, perform routine maintenance of laboratory instrumentation, and maintain complete and accurate records of instrument service and repairs in conformance with company SOPs and policies.

SUPERVISORY RESPONSIBILITIES:

• None.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 3 years of relevant industry experience; or,
• Master's degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 1 year of relevant industry experience; or,
• Equivalent combination of education and experience.

Experience:

• Demonstrated strong hands-on experience in ELISA and cell-based assays for mAb, BsAb and ADC.
• Working experience with a broad range of analytical methods, such as HPLC, icIEF and CE-SDS.
• Working experience in method development and troubleshooting in the lab.

Knowledge, Skills and Abilities:

• In-depth knowledge of CMC potency assays.
• Ability to collaborate with peers and cross-functional teams.
• Ability to multi-task in a fast-paced dynamic environment while delivering high-quality work.
• Good interpersonal, presentation, and written communication skills.
• Environment: primarily working in laboratories.
• Exposures encountered, such as hazardous materials, and extreme cold.
• Limited travel requirement.

Work Environment/Physical Demands:

Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.