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Bioprocessing Manager (3D)

All Openings | Research Triangle Park, NC | Full Time

Job Description

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 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:

This position reports to Director, Bioprocessing

Major Accountabilities:

  • Manages and develops manufacturing operators in all aspects of personnel management
  • Provides technical support as a subject matter expert on 3D processes and equipment and serves as a hands-on resource in Manufacturing
  • Troubleshoots equipment related issues and develops sound engineering solutions to address identified problems
  • Identifies and implements continuous improvement projects to improve yield, reliability, and/or process robustness.  
  • Leads and implements change controls
  • Develops and maintains departmental metrics and key performance indicators (KPIs)
  • Provides training to bioprocessing associates
  • Collaborates with other departments to ensure appropriate scheduling of manufacturing activities, maintenance and validation of equipment
  • Ensure oversight and coordination of ancillary 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
  • Represents the organization as the Bioprocessing subject matter expert in Regulatory submissions and inspections
  • Seeks out additional data from multiple perspectives to understand and resolve problems
  • Provide guidance to PD and other departments as appropriate as a technical resource
  • Applies functional and technical knowledge across a range of processes or operational procedures to deliver high quality work
  • Other duties, as assigned

Special Competencies:

  • Strong understanding of cGMP compliance in the biotech/bioprocessing manufacturing environment
  • Solid understanding of engineering principles and the ability to apply knowledge
  • Excellent organizational, planning and time management skills
  • Works as a team player, participating in activities that involve cooperating with others
  • Demonstrated leadership in a broad spectrum of bioprocessing applications and mentoring staff
  • Ability to manage a small team

General Competencies:

  • Able to communicate effectively in English, both verbally and in writing

  • Possess a positive roll-up-the-sleeves attitude and optimistic outlook

  • Represents the organization in a positive and professional manner

  • 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

  • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook

  • Must be able to work as needed to meet tight deadlines and at peak periods

  • Self-motivated and organized critical thinker with solid interpersonal and business communication skills

  • Demonstrated ability to work in a cross functional team

  • Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements

  • Always observe safety precautions and regulations in all areas where duties are performed

  • Responsible for reporting all safety hazards and potential unsafe working conditions

  • Reports to work on time and as scheduled

QUALIFICATIONS:

  • Bachelor’s in Engineering with 3+ years’ experience OR
  • Bachelor’s degree in science related discipline with 5+ years’ industry experience OR
  • Equivalent related industry experience (pharmaceutical, biotechnology, and/or sterile production environments)
  • 1-2 years of previous supervisory experience, preferably in manufacturing/bioprocessing
  • Relevant pharma bioproduction or bioprocess experience required
  • Basic mechanical aptitude or knowledge of electronic/mechanical equipment preferred.
  • Demonstrated knowledge of cGMP requirements, preferred.
  • Experience developing SOPs and documenting work preferred.
  • Strong background in aseptic processes
  • Advanced troubleshooting skills

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)
  • 12 Paid Holidays
  • Paid Parental Leave Policies

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