Process Development Engineer 2
The Process Development Engineer 2 with some direction will be responsible for the semi-independent conception, design, development, execution, and interpretation of scientific development projects, relating to the development, optimization, technology transfer and implementation of purification and/or production processes using scalable approaches and standard industry equipment and methods suitable for GMP manufacturing. This position will also support the overall Process Validation Program by reviewing past process data, conducting qualifications and preparing and/or executing validation documents as needed. This includes working with our contract labs and internal personnel for the generation, development, modification, and routing of Validation Protocols, Final Reports, Standard Operating Procedures, and Change Controls. The Process Development Engineer 2 will work in a collaborative team environment to develop a comprehensive understanding of our mammalian continuous cell culture production systems taking into account physical forces (ie. flow dynamics and sheer) which can impact product productivity and/or overall process yields and recoveries of Tocagen’s novel viral therapeutic products.
Duties and Responsibilities Include But Are Not Limited To:
- May work with other internal or external contractors to ensure timely completion of research and development projects; investigates the feasibility of applying a wide range of scientific principles and concepts to potential inventions and/or products.
- Understand the goals of the Product Development group and their relationship to strategic R&D, Manufacturing and corporate goals and objectives.
- Develop personal goals and maintain strategies to meet such goals within set timeframes.
- Independently or with team members, plan development projects requiring initiative, previous experience and good judgment within defined procedures and practices; independently select methodological approach and specific methods to achieve research and development objectives; exercise judgment and show initiative in making good and rational technical, scientific and project decisions.
- May involve travel and work on problems of diverse scope; identify, analyze, and interpret project results.
- Consistently read and apply concepts from pertinent engineering/process/scientific journals/articles, maintain relevant current scientific awareness, prepare written reports on all phases of laboratory and/or development work in collaboration with both internal and external scientists to the point of completion for IND submissions, development and technical transfer reports and/or publication for journal articles.
- Demonstrates consistent innovative contribution toward scientific and engineering solutions related to the company’s base technology and/or products.
- Conceives and writes original process qualification proposals to initiate method qualifications or validations to show method robustness, consistency, accuracy and validity.
- Presents and/or frequently participates in scientific/technical presentations at Journal Club and R&D Meetings.
- Contributes appropriate level of information in one-on-one and group meetings.
- Prepares effectively for meetings and succinctly presents ideas, demonstrates the ability to be an effective member of team(s).
- Major contributor in both data and written reports conforming to defined documentation practices in support of Process Development, Manufacturing, and , as well as regulatory filings, patent filings, grants and other company documents.
- Conceive and prepare project proposal recommendation for a novel processes or technical advancements.
- Prepare draft patents, defend patent disclosures and applications including examples or portions thereof.
- May provide guidance and/or training to other Engineers and Research Associates.
- Comply with the company safety policies and minimize risk to self, others and the environment, consistent with the community and industry standards.
Desired Knowledge and Abilities:
- In-depth relevant experience in process engineering and instrumentation plus formal coursework in at least one of the following; molecular virology, molecular biology, cell biology or biochemistry required, plus exposure in remaining areas.
- Requires expert knowledge of discipline including knowledge and development of protocols, scientific engineering methods and its applications, and the use of specialized engineering and process equipment.
- Demonstrated potential for technical proficiency, scientific creativity, collaboration with others, and independent thought concerning bioreactor or purification skid set-up and operation strategies.
- Excellent verbal/written communication skills and proficient computer skills.
- Demonstrated development accomplishments in an industrial setting, enjoys working in a fast paced, dynamic environment.
- Understanding, training and experience in mathematical modeling and scale down experiments to satisfy method validation rationales and requirements.
- Must have hands-on experience on large scale protein or viral product purification (≥ 200L scale).
- Proficiency in AKTA system and Unicorn programming.
- Common protein and/or viral in-vitro characterization techniques with experience with specific in vitro techniques such as mammalian cell culture, polyacrylamide gels, and ELISA techniques.
- Understanding of general molecular biology techniques including QPCR, and other analytical techniques.
- Data processing and statistical analysis skills (Excel, Prism), graphing and interpretation of experimental data.
Education and Experience:
- Engineering BS or MS degree plus industrial experience developing manufacturing processes for biological products associated with virology, immunology, cell biology and/or biochemistry or related scientific discipline.
- Minimum 4 years post BS or 1-2 years post MS graduation work (industry and academic).
- Minimum 2 years of direct industrial experience required.