Director, Manufacturing Operations

Job ID: req3721
Employee Type: exempt full-time
Division: Vaccine Clinical Materials Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 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 Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP biologics manufacturing, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

KEY ROLES/RESPONSIBILITIES

The Director, Manufacturing Operations, is responsible for providing central services in support of Phase I/ II biologics drug substance (DS) production and drug product (DP) filling operations; the role has oversight of cross-functional project scheduling, materials management/warehousing, buffer/solution prep, and facility cGMP cleaning operations.

• Accountable for the development, planning, implementation and maintenance of materials management, solution prep, scheduling processes, and cleaning operations.
• Works closely with quality groups to ensure strict compliance with good manufacturing practices/ cGMPs.
• Works closely with DS and DP manufacturing groups to support efficient production of quality products.
• Formulates and recommends manufacturing policies, standard operating procedures, and programs.
• Selects, develops, and evaluates personnel to ensure the efficient operation of biologics manufacturing functions and support groups.
• Owner of the materials management aspects of the enterprise resource planning /ERP tool (e.g., Sage X3)
• Experienced in solution/media prep, materials management operations, aseptic processing, and facility cleaning activities.
• Provides department-wide operations support including establishing more efficient systems and processes, technical evaluation of new technologies and resource prioritization.
• Drives continuous improvement and cost-savings initiatives across areas of responsibility.
• Leads infrastructure planning including equipment and/or system replacements/upgrades.
• Maintains and updates cleaning schedules for cGMP cleanroom areas and labs, ensuring return to service from shutdown activities; maintains cleaning schedules for office, warehouse, facilities, and ancillary areas.

BASIC QUALIFICATIONS

• Possession of a bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in chemistry, biochemistry, pharmaceutical sciences, or related field (Qualifying four (4) years' experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, must have ten (10) years of relevant experience in biopharmaceutical development and cGMP drug substance and/or drug product manufacturing operations support including 8+ years as a manager.
• Minimum 4 years' experience in solution/buffer formulation activities at scales up to 3000 L, including tech transfer of upstream/fermentation and downstream/purification media/buffer solution recipes.
• Knowledgeable of shipping/receiving/storage warehousing activities; f amiliar with clinical supplies/logistics, including basic experience in importing and exporting.
• Experienced with equipment and instrumentation associated with solution/buffer preparation, dissolution, sterile filtration, and analysis (i.e., buffer preparation skids, pH/conductivity meters, osmometers, viscometers/viscosity meter)
• Familiar with bacterial and mammalian bioprocessing operations geared toward DS manufacture; familiar with aseptic processing, formulation/filtration and automated filling operations used in DP manufacture.
• Must possess basic Microsoft Office skills.
• Must be able to obtain and maintain a security clearance.
• Ability to Manage the scheduling, materials management, warehousing, cGMP cleaning and solutions prep groups, in a multi-product cGMP production facility.
• Ability to identify potential issues and develop creative and innovative solutions to technical problems to keep projects on schedule with high technical probability of success.
• Ability to support manufacturing groups engaged in production of biotherapeutic, recombinant protein vaccines, nucleic acid (DNA, mRNA) vaccines; drives schedule integration to enable collaborative, accountable and efficient execution of manufacturing methods/procedures, bioprocesses and operations of new products and technologies.
• Ability to perform complex analysis of situations or data that require an in-depth evaluation of various factors.
• Ability to develop manhour projections required to perform buffer prep manufacturing processes.
• Ability to assure facility and equipment in manufacturing support areas of responsibility operate in a state of cGMP compliance, including proper maintenance, calibration, and validation state.
• Ability to mentor junior staff and be a catalyst for a learning culture while providing cross-training as needed.
• Ability to provide technical leadership in solving process performance issues involving equipment, scale, raw materials, process optimization, process changes and managing change control.
• Ability to engage in contingency/ disaster planning for business continuity.
• Ability to understand disinfection efficacy studies informing choice cleaning agents used in cleanroom areas.
• Familiarization with aseptic processing, including filtration and filling of formulated drug substance/ product.
• Experience with aseptic gowning and aseptic processing, including aseptic final sterilizing filtration; must have experience working in a cleanroom environment.
• Familiar with material handling and logistics including best industry practices, application of principles, concepts, practices, standards, validation, and qualification.
• Advanced knowledge of cGMP/GDP/Pharmaceutical regulations
• Strong knowledge and application of OSHA, DEA, USP and other applicable WH regulations
• Strong understanding of the regulatory issues associated with cGMP manufacturing of biopharmaceutical products and cGMP's as they relate to manufacturing operations/central services.
• Ability to execute the vision and strategic direction set by senior management.
• Ability to set operational goals for manufacturing operations group.
• Ability to provide direction, vision and leadership that impacts results.
• Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

• Familiar with international trade compliance laws and regulations including but not limited to, imports, exports, economic sanctions, Harmonization Tariff system (HTS), country of origin, boycott laws and Free Trade Agreements.
• Knowledgeable of nucleic acid vaccine manufacture, including plasmid DNA and mRNA vaccines.
• Familiar with mAb production, conjugate vaccine production and nanoparticle vaccine production.
• Experienced in supporting CHO-based mammalian cell culture production of monoclonal antibodies and recombinant glycoprotein vaccines for HIV passive/ active investigational trials.
• Experienced in supporting HEK293-based transient transfection-based production and purification processes for recombinant protein and/or Virus-like particle for investigational clinical trials.

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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

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