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Bioprocessing Specialist

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 Director, Bioprocessing

Primary Responsibilities:

  • Provides technical floor support to manufacturing operations, primarily in the 2D cell culture suite, but potentially including 3D and Packaging areas
  • 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
  • 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
  • Routinely communicate findings and information to other team members; transparency and knowledge sharing is expected and practiced

Special Competencies:

  • 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
  • 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
  • Demonstrated ability to work effectively within a team to set goals, develop sound project plans, monitor progress, and report results scientifically
  • Ability to work in or practical knowledge of clean room

QUALIFICATIONS:

  • Demonstrated leader with a Bachelor’s degree in Engineering with 2+ years’ experience OR Bachelor’s degree in science related discipline with 3+ years’ industry experience OR equivalent related industry experience required (pharmaceutical, biotechnology, and/or sterile production environments)
  • Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment, preferred
  • Experience developing SOPs and documenting work preferred
  • Basic mechanical aptitude or knowledge of electronic / mechanical equipment, preferred
  • Demonstrated knowledge of cGMP requirements, preferred
  • Basic knowledge of cGMP and FDA requirements, preferred
  • Working knowledge of cell culture principles, preferred

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