Scientist/Senior Scientist: Process Development – Analytical
Job Title: Scientist/Senior Scientist
Department: Process Development – Analytical
Reports To: Associate Director
FLSA Status: Exempt
Directs, plans, and oversees the organization's overall work in relation to scientific strategy and direction with a particular focus on process development with Antibodies and Antibody-Drug conjugates, innovation, evidenced-based practice, quality improvement, and professional leadership.
Essential Duties and Responsibilities:
• Participate in pre-clinical and clinical analytical development and stability study for Antibody/Antibody Drug Conjugate (ADC).
• Responsible for development, characterization and quantification of Antibodies, Antibody-Drug Conjugates (ADC), and their small molecule payloads in biological matrices
• Evaluate the identity and stability in vitro and in vivo of Antibodies and ADCs.
• Responsible for candidate optimization, selection, and validation.
• Hands on in UPLC, HPLC, CE, Osmolality, viscosity, solubility, CIEF, MALS, and other biophysical techniques. Mass Spectrometry is a plus
• Develop research plans, design experiments, outline research procedures to be followed, and identify or provides training to subordinate personnel to carry out research.
• Write and review Standard Operating Procedures (SOP)
• Establish relevant process transfer document and cGMP documents to support successful implementation of process technology in clinical/commercial manufacturing operations.
• Perform and report interim analysis of accumulated data to monitor for the safety of the drug or procedure.
• Support and closely work with research, cell-line development, upstream, downstream, and formulation groups.
• Work with R&D and manufacturing department in China to expand analytical capabilities. Plan time to accommodate meetings and technical support with team members in China
• Participate in timeline planning and decision making regarding research priorities of company or department and provide information on feasibility of prospective projects.
• Other duties as assigned.
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education & Experience
• PhD; MS; BS in Protein Science, Biochemistry or a related field with 5+ years (PhD); 9+ years (MS); 12+ years (BS) of relevant academic and/or pharmaceutical or biotech experience
• Strong fundamental knowledge and experience in antibody characterization
• Extensive experience with common bio-analytical methods including UPLC, HPLC, capillary electrophoresis, mass spectrometry is a plus
Ability to read, analyze, and interpret common scientific and technical journals. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small-group situations to customers, clients, and other employees of the organization. Ability to read or write in Mandarin is a plus.
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, and sampling theory. Ability to apply concepts of basic algebra and geometry.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions in written, oral, diagram, or schedule form.
Proficiency with Microsoft office required.
Certificates and Licenses
This position supervises Research Associates
Travel may be required
This individual will work in cell culture laboratory alongside other scientists and in a standard business office with desktop business equipment and a moderate noise level. Work hours will be flexible to ensure cell culture processes are properly monitored and maintained.
This individual must be able to handle standard laboratory and business equipment. Infrequent, moderate lifting of at least 50 pounds is required. Moderate standing and walking; frequent sitting; use of arms and hands to finger, handle, and feel; frequent use of hands for keyboarding; occasional stooping, kneeling, or crouching are required. Close, distant, and peripheral vision and depth perception used frequently. Environment is similar to office environment with quiet to moderate noise levels. Individual will work with toxic chemicals such as Antibody Drug Conjugates (ADC).