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Director, Bioprocessing Sciences & Technology (BSAT)

Manufacturing | Research Triangle Park, NC | Full Time

Job Description

Duties and Responsibilities:

  • Develop strategies, provides guidance and is accountable for ensuring that characterization of Humacyl Bioprocessing is done in a robust, scientific manner leading to predictable process performance and a well characterized process.

  • Identifies and drives continuous improvement in innovation and technology and contributes to a stronger IP position for Humacye. This position will support establishing state-of-the-art technologies for bioprocessing science as well as supporting facility, and production equipment modifications needed to maintain state-of-the-art production.

  • Leads and drives cross functional collaborations to ensure changes are truly state-of-the-art, integrate well into Humacyte systems and to ensure that best practices are shared.
  • Participates in training and development opportunities in order to gain an understanding of standards of practice, process science and departmental policies. Provides comprehensive training and guidance to experienced scientists.

Specific

  • Investigate, identify root cause, and identify CAPA for bioprocessing deviations.

  • Trend process performance.  Establish data analytics to serve as metrics, to assist in investigations, and as feedback to Process Development for scale up / process transfer.

  • Author technical reports and protocols in support of cGMP activities

  • Coordinate sampling plans for GMP batches related to lot release, stability, and characterization.

  • Partner with Process Development to ensure successful process transfer

  • Assist in equipment selection, qualification, and start up activities.  Work with Bioprocessing to ensure robust procedures are utilized for operation of equipment.

  • Manage external vendors to ensure delivery of raw materials, equipment, or services; on time and within budget.

Key Responsibilities

  • Working with Humacyte Bioprocessing, Process Development and Quality, proactively identifies initiates and executes process and procedural changes to improve business process performance, bioprocessing process robustness, productivity, safety and efficiency. The position is accountable for evaluating impacts of proposed changes on product quality and regulatory.

  • Provides guidance and is accountable for determining the root causes of process related deviations in a timely and conclusive manner. This position leads comprehensive data analysis of process statistics, identifies process deviations, assesses product impact, prepares technical reports and proposes comprehensive process solutions and improvements.

  • Initiates cross functional collaborations to align and recommend facility expansions/modifications to meet business needs. Develops strategies, provides guidance and is accountable for ensuring that designs for facility expansion and / or modification are optimized to support current and future Humacyl process requirements and are reflective of opportunities created by proposed process improvements.

Requirements:

  • BS, MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field.

  • 10-15+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.

  • Demonstrated knowledge of cGMPs and experience providing technical support in a cGMP bioprocessing environment.

  • Experience leading projects relating to bioprocessing deviations, change control, process optimization, technical troubleshooting, and bioprocessing process changes.

  • Strong experience working cross functionally within a BioPharma Bioprocessing organization leading projects across Process Development, Bioprocessing, Regulatory, Quality, and Engineering Services departments.

  • Strong Scientific and Engineering technical experience performing cell culture based bioprocessing activities involving vial thaw, inoculum, media development, media optimization, cell line development, and single use bioprocessing technologies.

    • Experience in risk assessment and characterization of extractables and leachables.

Bonus Points:

  • Expertise involving QbD (Quality by Design), process range studies, PAT, statistical analysis, process robustness studies, and Six Sigma.

  • Experience in validation of sterile bioprocessing processes including cleaning, autoclaving, depyrogenation, sterile filter, container closure, and process validation.

  • Experience in labeling and packaging of sterile products to produce finished goods.

  • Proven track record leading and managing cross functional teams.

  • Knowledge of data management tools and statistical process control

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