Program Manager

This Program Manager manages biomanufacturing process development and cGMP manufacturing projects of viral and mammalian products for clinical application as vaccines and biologics, including gene therapy applications. This position is responsible for program management and project management for manufacturing, analytical development/validation and fill/finish work.

• Oversee all aspects of managing process development and cGMP manufacturing projects for viral and mammalian products of clinical application. Have a strong working knowledge of process development and laboratory techniques associated with state of the art technologies.

• Perform gap analysis, regulatory requirements, market evaluation and economic feasibility of projects.

• Manage outsourcing and in-house projects for preclinical biologics/vaccine development projects that may include the following: process development, cGMP contract manufacturing, analytical testing, and CMC sections submission preparation.

• Manage the project lifecycle for all projects within the program scope for the key client program and ensure effective communication with all internal and external stakeholders. Tools include formal risk assessments with proper risk mitigation strategies, weekly/month reports, agendas and presentations, tracking and managing project budgets and full scale project plans/schedules with work breakdown structure. Includes frequent presentations on project status to ABL Executive Management.

• Support subcontractor management, if subcontractors are needed for the program.

• Contribute to internal initiatives for continuous improvement of ABL business processes and project delivery and profitability. Change management and training of colleagues within and outside the department is expected for improved performance on projects.

• Other duties as assigned.

Job Requirements

• Bachelor's degree in a scientific related discipline.

• A minimum of 5-10 years of experience in a biomedical development and clinical process setting for infectious diseases.

• Previous hands on working knowledge of process development and cGMP manufacturing for biologics.

• Proven aptitude for project management tools.

• Strong/effective interpersonal skills, both oral and written communication, and be able to communicate effectively with all echelons of Management and staff.

• Experience managing financial goals by forecasting requirements, tracking annual budgets, scheduling expenditures, analyzing variances, reporting revenue recognition, preparing technical progress reports and communicating financial summaries.

• Excellent proficiency using project management tools to oversee all elements of project lifecycle including scheduling/planning, meeting coordination, tracking of deliverables, reporting to stakeholders and risk mitigation.

• Demonstrated ability to work as a strong contributor in a team environment on complex projects.

• Proven multi-tasking skills able to handle multiple projects simultaneously; ability to motivate teams, work within aggressive timelines collaboratively with cross-functional departments.

• Proven and demonstrated computer (PC) and software skills including MS Office Suite programs, Internet, email systems. Experience with Microsoft Excel and Microsoft Project.

• Demonstrated ability to work as a strong contributor in a team environment and able to interact with all echelons of management and staff.

• Must be detail-oriented, dependable, motivated, ability to work with minimal supervision.

• Possess managerial courage

• Takes initiative

• Works well with all types of people

• Remains calm under pressure

Travel Expectation

ABL, Inc. participates in E-Verify, an Internet-based system of the Department of Homeland Security (DHS) and Social Security Administration, that allows us to determine an employee's eligibility to work in the United States.

ADDITIONAL INFORMATION:

• Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen.

• Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that "negotiable" is neither salary nor requirements. Salary commensurate with experience.

ABL, Inc. does not accept nor respond to unsolicited resumes from vendors, including recruitment agencies and search firms. Approved recruiting agencies must obtain prior approval from ABL, Inc. Human Resources in order to submit resumes to ABL, Inc. for consideration.