OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team as a Temporary Scientist III in Alameda, California. The Temporary Scientist III, Biologics Downstream Process Development role will independently conduct laboratory experiments with limited supervision to develop purification processes and support technology transfer and manufacturing of biological drug candidates. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
• Under minimal supervision, develop and execute laboratory studies in downstream process development (chromatography purification, viral filtration, TFF, etc.) to support unit operation scale up and technology transfers to enable clinical production.
• Undertake production campaigns from Lab - Pilot Scale
• Collaborate with internal and external partners in upstream process development, analytical development, and formulation development groups to advance CMC biologics programs
• 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 clean glassware.
• 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.
• Work to establish, maintain, and lead internal downstream process development and scale up lab capabilities in CMC Biologics
EXPERIENCE & EDUCATION
• Bachelors degree in chemistry, biochemistry, biochemical engineering, chemical engineering or related field and a minimum of three (3) years of relevant drug discovery/development experience; or,
• Masters degree in chemistry, biochemistry, biochemical engineering, chemical engineering or related field and a minimum of one (1) year of relevant drug discovery/development experience
To be a best-fit your strengths must include:
• Expertise in downstream (purification) process development
• Broad and deep knowledge of CMC biologics downstream processes
• Working knowledge of upstream process development, analytics, formulation development, and bioconjugation process development.
• Ability to apply technical knowledge to CMC development and manufacturing for biologics across the product life cycle
• Ability to multi-task in a fast-paced dynamic environment while delivering high quality work
• Strong understanding of cGMP quality and regulatory requirements for CMC biologics
• Sets goals with understanding of priority and impact to the program, department, and organization
• Excellent interpersonal, presentation, and written communication skills
• Excellent organizational and documentation skills and habits
• Creative thinker and complex problem solver
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.