Scientist, Analytical Development - Genetic Assessments

The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.

MDACC is investing in Biologics Development capabilities with the goal to develop industrial biologics with a commercial horizon within the innovative environment of an academic cancer center. The group will be a composite of industry veterans who are interested in applying their experience to develop innovative therapeutics and see them impact patients, as well as academics looking to turn science into products. Our unique approach has created a biotech-like engine within the walls of the nation's leading cancer center to bring life-saving medicines to our patients more quickly and effectively.

This Scientist will focus on Analytical Development of gene- and cell-based therapies and is a key talent reporting directly to the Head of Analytical Development and Characterization. The successful candidate will lead assay development and product characterization of genetically modified therapies, with major efforts to:
• Design assessments to address viral titer, viral potency, and transduction efficiency for therapeutics.
• Identify key metrics to help further characterize genetically modified products and identify potential Critical Quality Attributes.
• Identify sources of error and risk in repeated use of assessments over time and multiple users.
• Design stability studies of intermediate and final products.
• Coordinate efforts with the Product Development team for in-process or intermediate product assessments.
• Establish assays in preparation for tech transfer to QC, such as :
o Qualify assays by assessing sensitivity, precision, accurace, linearity, LOD, LOQ, robustness, etc.
o Craft SOPs and Test Forms suitable to facilitate tech transfer to GMP QC testing.
o Design stability protocols.

Since this is a new team being built with the successful candidate among the first hired, initial efforts in 2021 may also include activities related to starting a new program, such as identifying equipment to purchase, setting up procedures for equipment use, input into the design of laboratory space, etc. In addition, leadership within the Analytical Development team in terms of subsequent hires, establishing processes, and outreach to external groups is expected.

The successful candidate has developed viral vector-based assays for in-process or QC assessment. . The most relevant technical skills include cell culture and genetic analysis. The successful candidate also has strengths in thorough documentation, data presentation & statistical analysis, and oral & written communication to multi-functional teams.

Education

Required: Bachelor's degree in a related field.

Preferred: Ph.D. in related scientific /engineering field

Experience

Required: Seven years of relevant experience to include three years of supervisory or managerial experience. With Master's degree, five years of required experience to include four years of lead or supervisory experience.

Preferred:

• PhD in a relevant field with 3+ years of experience in development of cell-based therapies. Position level will be adjusted to match level of experience.
• Experience in viral vector analytics.
• Extensive experience with primary mammalian cell culture and genetic assays such as qPCR, ddPCR, NGS, etc.
• Demonstrated ability to collaborate effectively in a multi-disciplinary team.
• Demonstrated strong communication skills, interpersonal skills and a superior drive for results.
• Excellent written, oral, interpersonal and presentation skills and the ability to effectively interface with senior management and staff.
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.
• Ability to operate as an effective tactical, as well as strategic thinker.
• Ability to coach and influence junior level scientists and associates.

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html