Job Title: CMC Project Manager (remote)
Location: Location: Gaithersburg or Remote EST time zone preferred.
The CMC Project Manager (PM) works collaboratively with CMC Team Leaders and CMC scientists to ensure project goals and milestones are achieved by providing project management expertise, ensuring smooth and efficient operational implementation of CMC strategy, and enabling project delivery in line with time, financial and quality requirements. This role has a high job complexity and the successful candidate must have a high level of independence to meet requirements outlined below with minimal supervision.
Main Duties & Responsibilities:
• Manages BPD activities for specified projects, interfacing with relevant functional groups, and with external suppliers as necessary, to plan and coordinate the timely execution of CMC activities and contingencies.
• Leads and facilitates CMC Team meetings and responsible for project logistics and documentation. Ensures key project management tools are used appropriately to enhance project delivery and information dissemination to the business.
• Responsible for the production and maintenance of requisite project documentation to ensure delivery of the overall CMC Plan and milestones.
• Interfaces internally and externally as required in evaluation of material demand and to provide appropriate planning, coordination and communication to enable supply of materials and information of the required quality standard.
• Communicates effectively with all interfacing functions and relevant governance bodies as required.
• Influences, develops, maintains, owns and deploys key project management tools. Ensure tools are used appropriately to enhance project delivery and information dissemination to the business.
• Anticipates operational issues at the project level, and, working within the cross-project community, to influence solutions
• Understanding of biologics CMC development and manufacturing.
• Experience in planning and managing the cross functional aspects of biopharmaceutical product development.
• Knowledge and application of Project Management tools, such as Risk Management.
• high level of commitment, flexibility and independence with strong skills for planning, coordination, teamwork, communication and interpersonal relations.
• Effective working knowledge relevant to management of the technical disciplines represented within the CMC team.
• Comfortable with ambiguity. Must be professional, dedicated, and detail-orientated.
• Excellent oral and written communication, interpersonal, analytical, and computer skills.
• Effective problem solving and analytical skills to tackle and manage a broad range of issues and projects and deliver innovative solutions
• Highly organized and able to work independently on multiple tasks in a fast-paced environment
Note: This is not necessarily an all-inclusive list of job-related responsibilities, duties, skills, efforts, requirements or working conditions. While this is intended to be an accurate reflection of the current job, SPECTRAFORCE and the assigned client reserve the right to revise the job or to require that other or different tasks be performed as assigned.
Pay range: $83- $86.66 per hour negotiable based on experience and skills
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at [Click Here to Email Your Resumé] if you require a reasonable accommodation.