Associate Director of Assay Development

Location
Houston, Texas
Salary
Competitive
Posted
August 13 2021
Ref
142554
Discipline
Health Sciences
Organization Type
Healthcare/Hospital
Biologics Development
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. We work in a fast-paced, milestone-driven environment with a focus on team science and interdisciplinary research. 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.

Associate Director - Assay Development
This Associate Director will focus on Analytical Development of cell-based therapies and is a key talent reporting directly to the Head of Analytical Development and Characterization. As a senior member of the Analytical team, this position will lead a group of scientists and associates to design, develop, transfer, and maintain assays.

The primary responsibility of the successful candidate will be to lead assay development for release testing of cell and gene therapies, including phase-appropriate qualification of assays and tech transfer to the QC team. Major efforts will include:
• Design assessments to address the issues of identity, purity, and potency for therapeutics.
• Develop assays for tech transfer to QC, including :
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 Help train QC personnel in proper GMP execution of assays.
o Review QC SOPs and Test Forms for accuracy of tech transfer.
o Design stability protocols.
• Work closely with QC to maintain the lifecycle of assays, including:
o Conduct a risk assessment, identify main potential sources of error (e.g. over time or across operators), and select key parameters to monitor over time.
o Design assessments and execute assays to qualify raw materials used in QC

The successful candidate has experience in cell-based assays, has previously directed a team, and is technically knowledgable in mammalian cell culture, flow cytometry, and PCR. This individual also has strengths in data presentation, statistical analysis, report writing & editing, and presenting to multi-functional teams. Strengths in team management to meet timelines and goals is critical.

As a leader on a new and growing team, this individual will be instrumental in ongoing hiring and establishing procedures for new equipment. In addition, this position will need to help set up and optimize paradigms for collaborating and communicating with other departments within the organization as well as external groups.

Education

Required: Bachelor's degree in a related science field.

Preferred: PhD degree in a related scientific / engineering field.

Experience

Required: Eleven years of relevant experience to include six years of managerial experience. With Master's degree, nine years of relevant experience to include six years of managerial experience.

Preferred:

• Experience in Analytical Development, particularly as related to cell therapies.
• Understanding of the FDA Regulatory requirements as related to cellular identity, purity, and potency.
• Knowledge in mammalian cell culture, flow cytometry, and PCR
• Skilled in effective data presentation, appropriate statistical analysis, and report generation.
• Demonstrated strong communication skills and a superior drive for results.
• Excellent judgment and inter-personal skills, including negotiation and conflict resolution skills.
• Experience in managing teams to meet timelines and goals.
• Ability to coach and influence junior level scientists and associates.
• Demonstrated ability to collaborate effectively in a multi-disciplinary team.
• Excellent written, oral, interpersonal and presentation skills and the ability to effectively interface with senior management and staff.

Must pass pre-employment skills test as required and administered by Human Resources.

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

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