Job Description

SUMMARY/JOB PURPOSE:

The Scientist III, Biologics Downstream Process Development will independently conduct laboratory experiments with limited supervision to develop purification processes and support technology transfer and manufacturing of biological drug candidates. The incumbent will utilize their technical expertise in downstream/purification process development of biologics (therapeutic proteins, antibodies, bispecifics, ADCs, etc) to advance CMC development and manufacturing for pre-IND and in-clinic therapeutic proteins.? A strong technical focus is critical to ensure the speed, cost effectiveness, and technical quality of our CMC activities. The incumbent should have excellent hands-on technical abilities and a strong theoretical grasp of purification unit operations such as affinity chromatography, ion exchange chromatography (IEX), ultrafiltration/diafiltration (UF/DF), viral filtration, etc. The incumbent is expected to work in the laboratory full time, including operating state-of-art downstream equipment (FPLC, TFF, depth filtration systems, etc), performing 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. The individual should have familiarity with upstream process development, analytics, and formulation development, as they will be working closely with these groups, in addition to a general working knowledge of Biologics CMC.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Under minimial 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

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• Bachelor’s 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,
• Master’s degree in chemistry, biochemistry, biochemical engineering, chemical engineering or related field and a minimum of one (1) year of relevant drug discovery/development experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Experience applying their technical knowledge to drive critical objectives for CMC biologics across the product life cycle
• Hands-on experience in recombinant protein purification and downstream process development
• Familiarity with harvest and clarification unit operations
• Hands-on experience with Fast Protein Liquid Chromatography (FPLC) systems (e.g. Akta Avant, Akta Pilot, Akta Ready, etc) for chromatography-based purification development.
• Experience developing scalable chromatography purification unit operations (Affinity, IEX, HIC, SEC, mixed mode, etc).
• Experience developing scalable viral filtration and TFF unit operations.
• Working knowledge of CMC upstream process development, analytical development, formulation development, bioconjugation process development, technology transfer, and GMP quality requirements
• Ability to run basic analytical purity assays (SEC-HPLC) and in-process impurity clearance assays (HCP, res DNA, res ProA) independently
• Demonstrated capability to work independently on complex technical problems, effectively in cross-functional teams, and with external CDMOs and partners
• Experience planning, generating, analyzing, and linking experimental capabilities and results to critical CMC objectives

Knowledge/Skills:

• 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

WORKING CONDITIONS:

• Environment: primarily working in laboratories
• Exposures encountered, such as hazardous materials, and extreme cold.
• Limited travel requirement

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