Director, BDP

Job ID: req4740

Employee Type: exempt full-time

Division: Biopharmaceutical Development Program

Facility: Frederick: ATRF

Location: 8560 Progress Dr, Frederick, MD 21701 USA

The Frederick National Laboratory is 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 Frederick National Laboratory (FNL) 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, and applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

The Senior Vice President and Director of the Biopharmaceutical Development Program (BDP) is responsible for the overall direction of the operations/manufacturing functions of the NCI’s biopharmaceutical production facility for the development of experimental therapeutics for pre-clinical, and Phase I and II clinical trials in cancer and other diseases.

KEY ROLES AND RESPONSIBLITIES

• Overseeing manufacturing, quality control, materials and production control, and manufacturing related engineering, including all clinical grade production conforms to Food & Drug Administration (FDA) cGMP guidelines for parenteral drug facilities.
• The Directorate Head is responsible for a staff of scientific and technical employee who can assist investigators with technology transfer, process development and scale-up, and optimization of fermentation and product recovery conditions.
• Provides functional guidance to responsible managers. Applies effective leadership and interpersonal skills by use of strategic thinking, team and project leadership, personnel development and decision-making skills.
• Responsible for overall program administration including procurement support, budget administration and program reporting.
• Directs the overall operations of a complex, multi-disciplinary and high throughput production and development facility consistent with cGMP.
• Assesses information, regulations and customer needs based on sound scientific understanding, regulatory requirements and Standard Operating Procedures (SOPs).
• Documents in accordance with cGMP for the submission of an investigational new drug application for a clinical-grade product.
• Responsible for technology transfer of processes and methods. Responsible for optimization of processes, pilot production of small quantities of proteins for collaborative projects to establish production conditions and determine feasibilities for clinical products.
• Directs the organization towards the successful performance of contract requirements. Interactions with project teams and Biological Research Branch (BRB) of the Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI).
• Hires, trains, develops and appraises staff effectively. Recommends/carries out corrective actions as necessary on a timely basis and in accordance with company policy. Consults with Human Resources as appropriate.
• Provides assurance of proper subcontract and budget management per Policy and Procedures.
  
  

BASIC QUAILIFICATIONS

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

• cGMP regulatory requirements
• Industry standards, and issues applicable to Federal Drug Administration (FDA), Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency (EPA).
• Ability to plan, conduct and evaluate a large complex multi-disciplined program; recruit and maintain adequate staff as well as conduct employee performance evaluations.
• Understand the staffing and functional needs of a cGMP organization.
• Manage short and long-term functions within budgetary constraints.
• Maintains and applies a broad understanding of financial management principles to ensure decisions are fiscally sound and appropriate.
• Prepare acceptable reports and publications of program findings. Interface with supervisory and laboratory personnel.
• Ability to analyze manufacturing operations and personnel and implement in-process changes when appropriate.
• Experience with successful technology transfer of biological products in cGMP manufacturing facility.
• Ability to obtain and maintain a security clearance.
  
  

Educational Requirements

• Possession of a PhD degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) appropriate to biopharmaceutical development., including but not limited to degrees such as Biology, Biochemistry, Cell Biology, Biophysics. Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of seven (7) years of extensive management experience in a highly collaborative environment.
• Foreign educated candidates who have completed part or all their education outside of the United States must have their foreign education evaluated by a contractor-approved accrediting organization to assure it has met the equivalency of the qualifications of degree work in the United States.
• Demonstrated experience in integrating complex projects with previous exposure to all facets of cGMP operations.
  
  

Commitment to Non-Discrimination

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, 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. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

Pay And Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

204,100.00 - 292,400.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions