Sr. Project Manager/Project Manager - CMC
Rockville, MD 
Share
Posted 22 days ago
Job Description
Description

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer.Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe.

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

The Sr. Project Manager for CMC leads several programs in MacroGenics' product pipeline and is responsible for cross-functional CMC strategy and operational matrix management of the CMC development plan, which includes activities in biopharmaceutical process development, manufacturing, quality and regulatory affairs. The Sr. Project Manager for CMC also leads the alliance management for CMC contract and with collaboration partners to ensure completion of deliverables.

Responsibilities and Job Duties:

  • Leads the cross-functional CMC team meetings and ensure team focus on key decisions and milestones and drive accountability to achieve goals
  • Champions the CMC aspects (strategic and operational) to the Product Development Teams (PDT) for assigned product development programs.
  • Leads the development of and maintains the integrated CMC plan (activities and timelines).Ensures proper alignment with the overall project plan.
  • Monitors deliverables and communicates regular updates of program status to stakeholders via dashboards and other cross-portfolio project management tools
  • Independently manages day to day project and/or team activities and issues; obtains management guidance for strategic or complex topics
  • Collaborates with functional representatives to proactively anticipate and identify project risks and develop action and resolution plans
  • Ensures the team and stakeholders have the right information for decisions and leads the team through problem solving, decision discussions and contingency planning
  • Establishes and maintains effective communication channels to provide accurate information to the CMC Management Team, functional line management, PDT and other governance bodies (internal and external) as required.
  • Chairs joint meetings with partners including proactive agenda development and meeting preparation
  • Acts as liaison between internal and partner project teams and drive collaborative planning and execution to achieve partnership goals and objectives.
  • Assists in maintaining CMC project management tools like cross-functional program portfolio timelines, publishing monthly CMC dashboards, building CMC goals, etc.

Minimum Qualifications

Education & Credentials

  • Bachelor's degree in a relevant technical or scientific discipline

Experience

Sr. Project Manager

  • At least 7 years' experience in biotech/pharma industry with relevant Bachelor's degree

OR

  • At least 5 years' experience with Master's degree in a scientific field
  • A minimum of 3 years of prior experience managing CMC projects
  • Direct experience in one or more areas of CMC biopharmaceutical or related product development field (e.g. process development, technical services, quality, manufacturing, regulatory, clinical supply)

Project Manager

  • At least 5 years' experience in biotech/pharma industry with relevant Bachelor's degree

OR

  • At least 3 years' experience with Master's degree in a scientific field
  • A minimum of 2 years of prior experience managing CMC projects
  • Direct experience in one or more areas of CMC biopharmaceutical or related product development field (e.g. process development, technical services, quality, manufacturing, regulatory, clinical supply)

Knowledge, Skills and Abilities

  • Demonstrated understanding of project management principles applicable to bio/pharma
  • Demonstrated ability to balance scientific, technical and business priorities
  • Capable of concurrently and efficiently managing multiple projects
  • Well-organized with ability to effectively prioritize
  • Ability to navigate project teams throughout ambiguous situations
  • Conflict management skills
  • Strong decision-making skills
  • Demonstrated ability to work with cross-functional teams in a matrix environment
  • Strong interpersonal skills, collaborative mindset, ability to develop working relationships with colleagues at all levels of the organization
  • Strong written and verbal communication skills are required
  • Planning and monitoring skills with strong attention to detail including direct experience with project management tools

Supervisory Responsibilities

No

Preferred Qualifications

Professional project management certification

  • Experience managing or leading teams
  • Experience in managing external partners (collaborators)
  • Experience in the generation of regulatory filings (INDs and BLAs)

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.

To promote the health and well-being of our employees and ensure business continuity, MacroGenics requires all new hires to be fully vaccinated for COVID-19 by his/her start date. A new hire will need to either (a) establish that they have been fully vaccinated or (b) obtain an approved exemption as an accommodation.






MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
7+ years
Email this Job to Yourself or a Friend
Indicates required fields