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Manager, Validation

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 VP, Commercial Manufacturing

Primary Responsibilities:

  • Oversees daily operations of the Validation function within the MSAT organization
  • Works collaboratively with Engineering, Facilities, Product Development and Manufacturing Operations to achieve common goals
  • Participates in team meetings related to changes in processes, process improvements and provide suggestions, as needed
  • Provides coaching and training and guidance on aspects of the validation process with the validation team members
  • Writes reviews and/or approves protocols and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory requirements, and current technology
  • Ensures that validation and qualification activities are consistent with company validation policies and procedures and federal regulations
  • 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
  • Ability to work effectively within a team to set goals, write technical and validation reports, and resolve compliance issues in scientific and industry-standard terms, as required
  • Routinely communicate findings and information to peers and other team members; transparency and knowledge sharing is expected and practiced
  • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook

Special Competencies:

  • Ability to work in a team structure to plan, organize and prioritize work consistent with Company and Department goals
  • Demonstrated understanding of facility, utility, and equipment life cycle management and requalification programs.
  • Excellent written and oral communication skills.
  • Strong understanding of U.S. cGMP, ISO, ICH, and EC compliance requirements and ability to maintain compliance within their scope
  • Excellent knowledge of pharmaceutical Quality Systems and Qualification and Validation standards and industry practices
  • Strong understanding of aseptic processing requirements

QUALIFICATIONS:

  • Bachelors or Master’s Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, or related areas
  • 8-10 years of pharmaceutical work experience with at least 2 years in a Management role
  • Experience in developing and reviewing Block Flow Diagrams, Process Flow Diagrams, Piping and instrumentation Diagrams
  • Experience reviewing/developing URS, FRS, preparation of technical comparisons, DQ, FAT, SAT, commissioning, qualification and validation
  • Specialized training in pharmaceutical facility/utility/software validation, highly preferred
  • Direct experience with commissioning, qualification, and validation, with expert understanding of regulatory requirements for documentation and records
  • Prior experience with regulatory inspections, highly preferred
  • Experienced, accomplished personnel manager and leader with strong interpersonal, business and communication skills
  • Experience in evaluating technical quality problems and providing recommendations for corrective actions
  • Hands-on experience in qualification of biopharmaceutical facilities as per cGMP requirements

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