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Bioprocess Specialist

Manufacturing | Research Triangle Park, NC | Full Time

Job Description

About Us:

Humacyte's mission is to become the leading company in novel, off-the-shelf extracellular matrix tissue products, and especially those that could provide lifesaving improvements in treatments for vascular conditions.

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.

Responsibilities:

  • Provides technical support to manufacturing operations. Revises standard operating procedures and batch records, reviews design documents, leads investigations, solves problems to root cause, implements corrective actions, implements change controls, operates automated equipment, executes standard operating procedures, executes validation qualifications, and leads improvement projects.

  • Troubleshoots equipment related issues and develops sound engineering solutions to address identified problems.

  • Leads non-conformance investigations to adequately identify root cause and implements appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence. Employs standardized root cause analysis, investigation tools and methodologies.

  • Identifies and implements continuous improvement projects to improve yield, reliability, and/or process robustness. This may require leading and implementing change controls.
  • Develops and maintains departmental metrics and key performance indicators (KPIs).
  • Provides training to bioprocessing associates.
  • Responsible for scheduling manufacturing activities as well as coordinating equipment maintenance and validation, as  needed.
  • Responsible for coordinating activities to support manufacturing (i.e. raw materials and BPR issuance) as   needed.
  • Ensures manufacturing goals are achieved through robust safety practices and quality compliance.
  • Becomes expert on processes and equipment and serves as a hands-on resource in Manufacturing.

Requirements:

  • Demonstrated leader with bachelor’s degree in engineering or science related discipline with 1+ years’ industry experience OR equivalent related industry experience experience (pharmaceutical, biotechnology, and/or sterile production environments).
  • Basic mechanical aptitude or knowledge of electronic / mechanical equipment preferred.
  • Demonstrated knowledge of cGMP requirements preferred.
  • Experience developing SOPs and documenting work preferred.
  • A solid understanding of basic engineering principles and the ability to apply your knowledge
  • Basic  troubleshooting skills
  • Excellent organizational, planning and time management skills
  • Strong oral, written  and  interpersonal  communication skills
  •  

Bonus Points:

  • The ability to work effectively in both a team environment and an individual contributor role
  • The ability to perform in a high performing workforce.
  • Works as a team player, participating in activities that involve cooperating with others
  • Applies functional and technical knowledge across a range of processes or operational procedures to deliver high quality work
  • Seeks out additional data from multiple perspectives to understand problems

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 3 Weeks’ Vacation
  • 5 Personal Floating Days
  • 8 Sick Days
  • 6 Company Holidays
  • Career Development and Training