1+ months

Project Manager - Department Lead

Biologics Consulting Group, Inc.
Alexandria, Virginia 22314 Work Remotely

Biologics Consulting, Inc. (BC) seeks to hire a full-time Project Management (PM) Lead with ‘hands-on’ experience in the Biotech, Pharmaceutical, or FDA Project Management environment (required). The successful candidate will be able to work independently, be a self -starter, a proven leader, with strong oral and written communication skills, and have the ability to multi-task. The Project Management Lead is responsible for leading and managing Project Management staff (5) and working directly with Clients and BC Consultants.  

Candidate may work predominantly from home; however, must be located in proximity to work in our Alexandria, Virginia office, as necessary.

Key Accountabilities:

· Develop, implement and/or maintain systems and processes to optimize efficiency within department.

  • Provide oversight of proposal development processes for all multi-disciplinary projects.
  • Coordinate the activities and output of multi-disciplinary Consultant teams assigned to Projects.
  • Line management responsibilities for department include triage of work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance.
  • Lead or assist with preparation of business development proposals and responses to RFP’s (request for proposals).
  • Track performance metrics within the PM department.
  • Track business development leads and project opportunities
  • Keep abreast of relevant FDA regulations, inform PMs and apply such knowledge and guidance to client projects
  • Provide project management support, including but not limited to:
    • Project budget analyses
    • Timeline development and tracking
    • Communication facilitation and conflict resolution among team members (Biologics and Client)
    • Attend industry relevant meetings to advance current knowledge base and leverage business development opportunities with Clients and potential Clients.
    • Provide strategic department/project updates to management through periodic updates, monthly reports, and/or meetings.
    • Miscellaneous Administrative duties as necessary


Basic Qualifications:

  • MS in Biological Sciences, Project Management, or Engineering
  • Experience in the Biotech, Pharmaceutical, or FDA Project Management environment (Required).
  • 5+ years managing cross-functional projects/teams using project management methodologies and tools for complex product/process development environments
  • Working familiarity with FDA and/or ICH regulations
  • Project Management Professional (PMP) Certification preferred

Preferred Qualifications:

Advanced degree (e.g. Ph.D) in Natural Sciences

Skills: Proficient in Microsoft Office Suite, keyboard skills, oral and written communications skills, strong documentation skills, math aptitude, diplomacy, professionalism, organization, time management, ability to multi-task, able to work unsupervised, able to maintain confidentiality

Education and/or Experience: College Degree required – preferred in field of Biology, Natural Sciences or Regulatory Affairs. Prior experience in regulatory affairs is advantageous.

Biologics Consulting Group, Inc. (BCG) is an international consulting firm whose consultants provide national and international regulatory and product development advice on the development and commercial production of biological, drug, and device products. Our staff consists of experts in regulatory affairs, product manufacturing and testing, pharmacology/toxicology, facility inspections, statistics, program management, and clinical trial design and evaluation. Many of our consultants are former CBER, CDER and CDRH reviewers, certified FDA inspectors, and senior scientists from the biotechnology industry. We offer a great work environment, as well as a highly competitive salary and benefit package, including healthcare and 40lk plans.

An immediate start is preferred.

To learn more about Biologics Consulting Group, Inc., please visit our website at: www.biologicsconsulting.com


Posted: 2019-10-09 Expires: 2019-11-23

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Project Manager - Department Lead

Biologics Consulting Group, Inc.
Alexandria, Virginia 22314

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