BioProcess Development Scientist 1

Location: San Diego

POSITION SUMMARY:

The Bioprocess Development Scientist 1 will have experience in protein purification and analysis, excellent communication skills, and a collaborative mindset to efficiently work in a team.  Specifically assists in the development, execution, and documentation of scalable protein purification processes at the small scale to pilot scale, as well as with transfer to external manufacturing facilities. He/she will participates in the development and documentation of process steps for harvest clarification, column chromatography, tangential flow filtration, and viral clearance steps (filtration and inactivation) and works closely with cross-functional counterparts in the upstream, analytical, , manufacturing, quality and regulatory groups to ensure corporate goals are achieved.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:

• Author, review, and execute protocols as necessary to purify recombinant proteins using various purification modalities
• A thorough understanding of purification process development for early and late stage protein therapeutics is required with a broad understanding of downstream development and scale up including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal
• Sets up and performs scale down models to assist with process validations, viral clearance studies, and manufacturing investigations, providing analysis as needed
• Conduct and document in-depth process characterization of established legacy processes
• Collaborate on the design, execution, and interpretation of lab scale experiments towards developing GMP scale manufacturing processes (e.g. DOE studies)
• Authors and reviews internal and reviews external technical documents such as protocols, reports, regulatory, and process transfer documents
• Generate complete records of process experiments in laboratory notebooks and batch records for internal use and transfer to external facilities
• Prepare chromatography columns and buffers for bench scale work and pilot scale runs
• Configure, calibrate, and use filtration systems, in process automation systems (e.g., ÄKTA/Unicorn), associated instrumentation, and computer systems
• Execute processes using appropriate aseptic techniques
• Create, review and revise laboratory SOPs and batch records
• Maintain a high level of productivity in the lab
• Effectively coordinate with colleagues and research teams
• Learn and effectively implement new experimental protocols
• Consult relevant scientific literature to understand project context
• Candidates should be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking.
• Maintain, clean, and organize the lab environment for efficient workflow and order lab equipment and reagents/supplies to maintain inventory in support of Bioprocess development activities
• Follow all company policies, safety regulations, equipment manuals, and standard operating procedures (SOPs)

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:

• Travel to Contract Manufacturing Organizations (CMO) and conduct technology transfer activities, as needed
• Contribute to authoring and reviewing CMC sections of regulatory submissions and responding to regulatory information requests is preferred
• Recommend and implement innovative process ideas to increase efficiency of laboratory management activities
• Participates in group meetings. Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work
• Enhance professional growth and development through pro-active participation in educational programs, current literature, in-service meetings and workshops.
• May present to internal groups
• Attends relevant meetings and seminars
• Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• Minimum Bachelor’s degree in chemistry or related life sciences with minimum of 12 years’ experience in the biotechnology industry (an equivalent combination of experience and education may be considered),
• Established skills developing various chromatography modes of action (ion exchange, hydrophobic interaction, size exclusion, and affinity) for protein separations
• Hands-on experience running filtration technologies such as Tangential Flow Filtration, nanofiltration, harvest depth filtration, and sterile filtration
• Demonstrated experience with performing technology transfers to CMOs
• Proven experience developing scaled-down models’ representative of manufacturing scale for process characterization, viral clearance, and resin dynamic binding capacity studies
• Demonstrated ability to perform calculations for the accurate preparation of buffers / solutions / reagents to support purification development activities
• Comprehensive knowledge of purification systems such as: AKTA Explorer, AKTA Avant, ATKA Pilot and AKTA Ready and Unicorn software
• Basic understanding and ability to apply analytical techniques like Spectroscopy, SDS-PAGE, Western Blot, ELISA, and HPLC (SEC, RP, IEX, etc.)
• Experience with statistical experimental design (DOE) and software (i.e. JMP)
• Consistently prepares and presents high quality reports and presentations describing scientific information
• Excellent investigational and observational skills, attention to detail, and ability to reproduce or troubleshoot experimental results
• Proven ability to independently research in support of experiments and processes that do not perform as expected is required (i.e., self-directed investigation skills)
• Good organizational skills in support of laboratory hygiene and standard practices
• Excellent lab notebook and record keeping skills
• Knowledge and understanding of a GMP environment
• Master’s degree preferred
• Experience reviewing, contributing, or authoring CMC sections of regulatory submissions and responding to regulatory information requests is preferred.

TECHNICAL KNOWLEDGE REQUIRED:

Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: N/A

Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software required: Unicorn software for writing methods for the AKTA systems (training can be provided)

INTERNAL AND EXTERNAL RELATIONSHIPS:

• Interface with upstream bioreactor and analytical scientists and manage storage and handling of process intermediates and samples
• Productively interact with senior scientists in the Research team to transfer processes into Process Development
• Interface with scientists in Manufacturing, Analytical, and Formulation Development teams and obtain analytical results required to develop, optimize, and characterize processes
• Interface with Quality and Regulatory teams as needed
• Interface with third party vendors and CMOs to conduct studies and manufacture product required to support GMP development and manufacturing

EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting to 50 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.

TRAVEL:

Travel may be required up to 15% of your time

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