Process Development Manager III, CGR

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Job description

Process Development Manager III, CGR

Job ID: req4101
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: Rockville: 9615 MedCtrDr
Location: 9615 Medical Center Drive, Rockville, MD 20850 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION

The Cancer Genomics Research Laboratory (CGR) investigates the contribution of germline and somatic genetic variation to cancer susceptibility and outcomes in support of the NCI's Division of Cancer Epidemiology and Genetics (DCEG), the world's most comprehensive cancer epidemiology research group. CGR is located at the NCI-Shady Grove campus in Rockville, MD and operated by Leidos Biomedical Research, Inc. We care deeply about discovering the genetic and environmental determinants of cancer, and new approaches to cancer prevention, through our contributions to the molecular, genetic, and epidemiologic research of the 70+ investigators in DCEG. Working in concert with epidemiologists, biostatisticians and basic research scientists in DCEG's intramural research program, CGR provides the capacity to conduct genome-wide discovery studies and targeted regional approaches to identify the heritable determinants of various forms of cancer. This includes the design and analysis of high throughput studies using various types of "-omics" technologies such as array- and sequence-based genome-wide studies, analysis of tumor characteristics using integrated genomic data approaches, and molecular epidemiologic studies based on novel assays. We are seeking a highly motivated, independent scientist to lead our Development, Optimization & Implementation team to establish and support new pipelines for numerous technologies required to support DCEG investigators and CGR in multiple areas of human, bacterial, and viral nucleic acid research. Additionally, the successful incumbent will have significant expertise in high throughput automation, workflow and SOP development, LIMS user requirement design and technology transfer into multiple environments.

KEY ROLES/RESPONSIBILITIES

• Work in close coordination with other CGR groups and DCEG investigators to develop, optimize and implement new protocols and applications into CGR laboratories for molecular and digital pathology, sample extraction and characterization, genomics (germline and somatic), and proteomics analyses.
• Conduct hands-on laboratory research activities involving assay development for genomic, proteomic, viral and microbiome testing.
• Demonstrable skills in experimental design, including capabilities in data analysis, interpretation, and visual presentation of results.
• Ability to contribute to and lead scientific publication development.
• Maintain thorough electronic documentation records of experimental plans, data, results, and next steps.
• Preparation of results in report format and presentation in cross-functional meetings with senior CGR leadership and DCEG investigators.
• Author documents supporting applications and convert newly developed protocols and procedures into SOPs.
• Demonstrable ability to train staff and implement new protocols.
• Design and implement technical automation solutions for a wide array of applications and maintain a suite of liquid handlers, robotic equipment, and integrated instrumentation with an eye towards fault-tolerant workflows to increase productivity, throughput, and consistency of laboratory processes and procedures.
• Experience in management of staff in a cross-functional matrix organization.

THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of eight (8) years of related biomedical experience.
  • Including six (6) years in a leadership/manager capacity.
• Proven and demonstrable capabilities to transfer complex workflows to collaborating sites (US and international) as required.
• Demonstrated expertise with DNA/RNA extraction, RNA handling, nucleic acid quantitation and quality analysis and advanced molecular biology techniques.
• Proven experience of method qualification/development or validation for testing of DNA and RNA, including approaches for benchmarking and optimization.
• Prior experience working in a fast-paced development environment with GLPs and safe handling of biological material.
• Strong technical and analytical skills for method/assay development and troubleshooting are required.
• Expertise with design and scripting/coding of application-specific protocols for complex automated instrumentation, mechanical and programming troubleshooting, ability to learn new robotic operating systems, and ability to train personnel on highly technical systems.
• Proven experience in developing user requirements for LIMS and/or eLN tools.
• Excellent time and project management skills, with ability to work on several projects simultaneously.
• Attention to detail and ability to independently identify critical variables.
• Outstanding communication skills (verbal and written).
• Good interpersonal skills and ability to mentor and train direct staff and collaborate with a wide variety of laboratory and bioinformatics staff.
• Exceptional knowledge of Windows-based computer operating systems and Microsoft office suite.
• Ability to work in a fast-paced setting and effectively collaborate in a highly dynamic, cross-functional environment.
• Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Substantial experience with a wide range of specimens and analytes used in genomics, transcriptomics, and proteomics.
• Expertise with a wide range of nucleic acid extraction methodologies used in both home-brew and commercially manufactured products.
• Experience with quality management aspects including equipment and inventory control, deviations, and continual process improvement.
• Familiarity with basic bioinformatics and statistics, including experience with data visualization tools.

JOB HAZARDS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, color, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law.

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