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Project Manager

All Openings | Research Triangle Park, NC | Full Time

Job Description

**Please note, Humacyte does not provide sponsorship at this time.**

Humacyte, Inc., a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies.  We are currently developing multiple vascular tissue engineered therapies and expanding our business model.  With a broad pipeline of potential new therapy applications, we continue to build our organization and scientific teams.  We are looking for additional biomedical research and development colleagues to continue to build our expanding team.

Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.

Position Background:

Position reports to the Senior Program Manager

Primary Responsibilities:

  • Support Senior Program Manager in maintaining broad overview of lead product program status to support alignment across CMC, Quality, Regulatory, Program Management, and Supply Chain functions
  • Track and manage assigned projects, sub-teams, and tasks to support company goals and overall program timeline
  • Organize and facilitate meetings with standing and ad-hoc teams to support company goals and program timeline, including developing meeting agendas, authoring and distributing meeting minutes, and tracking action items to completion
  • Maintain integrated and stand-alone program plans with frequent updating of interdependencies through regular communication with functional / technical area leads
  • Integrate cross-functional activities by partnering with project / line leads to set priorities, define deliverables, and plan activities to deliver project goals and objectives aligned to the integrated program plan
  • Influence and negotiate with program team and stakeholders to gain alignment within the team and support conflict resolution
  • Maintain a broad overview of program status with respect to development history, risks and issues, and strategic cross-functional activities to ensure visibility of key scientific, technical, and operational work streams at the senior leadership level
  • Proactively manage key actions and deliverables through to effective resolution
  • Support the timely review and governance of program with key stakeholders at critical milestones
  • Develop project and program management tools and techniques to facilitate knowledge management and communication across the organization
  • Ensure traceability of key knowledge management documents and information to support regulatory filings and other critical processes
  • Exercise sound judgement in determining appropriate project communications to internal and external stakeholders
  • Develop and maintain key project and program related documents (meeting minutes, action and decision logs, project history files, etc.) that support knowledge management and communication across the organization
  • Other duties, as assigned

General Competencies:

  • Possess a positive attitude and optimistic outlook
  • Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
  • Excellent organizational and time management skills with ability to set own priorities in a timely manner
  • High degree of flexibility and adaptability
  • Strong communication (verbal and written) and organizational skills
  • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Motivated and organized critical thinker with solid interpersonal and business communication skills
  • Able to easily collaborate with a range of internal clients / customers
  • Build Consensus
  • Possess strong analytical skills

Special Competencies:

  • Proven track record of cross-team project management of complex, scientific projects in a pharmaceutical / biotech environment
  • Demonstrated ability to integrate science, development knowledge, and regulatory expectations to create and execute program and project plans
  • Program/project management experience with development, technology transfer, and commercialization of pharmaceutical and/or biotech products
  • Learning agility and flexibility in taking on a range of responsibilities that may be outside of current scope of experience
  • A passion for working hard as part of a team dedicated to bringing cutting-edge tissue engineered products to clinical translation is a must

QUALIFICATIONS:

  • BA/BS in scientific and/or engineering related discipline
  • 4+ years of experience in pharmaceutical and/or biotech industry with minimum of 2+ years of experience in project management role and/or cross-functional project management activities in a scientific / technical role (Please note, project management experience in IT, clinical or other disciplines will not be considered.)
  • Relevant pharmaceutical or biotech industry experience as a project manager or technical project lead, including cross-functional program/project management, required
  • Experience with cross-functional biologics and/or drug development processes and relevant CMC regulatory requirements
  • Experience with late-stage development, technology transfer, and commercialization of pharmaceutical and/or biotech products, strongly preferred 
  • cGMP bioprocessing / manufacturing / technology transfer experience is strongly preferred
  • Proven ability to manage and prioritize multiple projects of varying technical and organizational complexity
  • Experience in development and implementation of project management tools and techniques
  • MS Project experience

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 23 Days Paid Time Off (PTO)
  • 11 Paid Holidays
  • Paid Parental Leave Policies

**Please note, Humacyte does not provide sponsorship at this time.**