Senior Scientist - Operations
3401 Masons Mill Rd Bryn Athyn, PA 19009 US
As a Senior Scientist – Operations, you will oversee the production of circulating tumor cell assay reagents in a cGMP environment, including those which require conjugation of a variety of fluorochromes to purified antibodies directed at detected circulating tumor cells (CTCs). Candidates must have strong analytical skills, strong oral and written communication skills, good documentation practices, and experience working with Quality Systems that govern document management, change control management, deviations, and CAPA.
Essential Functions • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Executes production orders for assay reagents and intermediates as assigned, may suggest and/or implement changes to procedures if appropriate.
• Operates instruments and equipment to perform aspects of both functional and analytical testing in accordance with laboratory safety procedures and standard procedures.
• Performing routine maintenance of current laboratory equipment and analytical instruments as specified in equipment SOP.
• Serves as a subject matter expert for protein chemistry in particular antibodies, antibody purification, antibody conjugation, and HPLC/FPLC. o Must have an in-depth knowledge and hands-on (wet lab) experience with HPLC/FPLC technologies.
o Must have an in-depth knowledge and hands-on (wet lab) experience of different protein chemistry technologies including but not limited to purification of antibodies produced from hybridomas, conjugation of antibodies, and purification of conjugated antibodies.
o Be familiar with different HPLC/FPLC data processing and interpretation of solutions.
o Knowledge of cell culture a plus • Strong experience with cGMP, good documentation practices and reporting o Full understanding of laboratory requirements, SOPs, FDA guidance
o Technically proficient in general laboratory practices (biochemistry/protein chemistry) • Experience working in Quality Systems governing document management, change control management, deviations, and CAPA.
• Attention to detail, careful record-keeping, a high level of organization, and good verbal and written communication skills
• Strong data analysis skills: ability to analyze large datasets in statistical packages.
• Ability to independently perform root cause analysis for method investigations
• Time management and project management skills
• Ability to work in a collaborative work environment with a team
• Self-starter who can operate with minimal supervision o Must have strong organizational and interpersonal skills, must display excellent leadership and people skills, and demonstrate ability to work collaboratively with others in a highly matrixed environment.
o Must be able to quickly adapt to changing priorities and work well in fast pace environment.
o Prioritizes risks and implements contingency plans
Required Education and Experience • BS in life or medical sciences (chemical or protein/protein engineering) required, MSc or above preferred.
• Minimum of 5+ years of directly relevant biotechnology or pharmaceutical industry experience.
• Candidate must be a rigorous, detail-oriented scientist, with excellent record keeping and organizational skills. Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast paced dynamic environment.
• Strong knowledge of cGMP and FDA regulations
• Outstanding expertise in HPLC/FPLC and protein chemistry focused on antibody production, purification, and conjugation.
• Knowledge of cell culture a plus
• Demonstrated ability to initiate and carry projects through to conclusion.
• Strong verbal and written communication skills
Work Environment • This job operates in a professional office and laboratory setting. This role routinely uses standard office and lab equipment. Physical Demands • This is largely in the production laboratory and some general movement is required. This would require the ability to lift objects approximately between 20-40 lbs, move laboratory supplies or products, bend or stand for extended durations as necessary. Position Type/Expected Hours of Work • This is a full time, exempt, professional-level position. This position is an on-site role and typical days and hours of work are Monday through Friday, 8:00 a.m. to 5:00 p.m.; however, this position may require longer hours, evening, and weekend work as necessary. Travel • This position may require travel, approximately 5% or less. Other Duties • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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