Senior Bioprocess Development and Commercial Lead - Job # 2334

Additional Information
  • For confidential consideration please submit a resume and salary history to claire@fullscalesolutions.com.
  • Please be sure to include the job number with your submission.
  • Full Scale Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Client Synopsis:

Full Scale is currently recruiting for the following Raleigh-Durham based position. Our Client is a pioneer in the development of human biotherapies.

Essential Duties and Responsibilities:

The successful candidate could be placed up to and including a Vice-President level and join the Leadership Team, depending upon previous level and experience. Incumbents must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment, and lead other professionals and peers.

This incumbent will be responsible for leading and directing the process development/engineering team for the vascular graft product line. This leader will help optimize our current bioprocess development and, together with contract engineering firm or firms, create the future commercial manufacturing system for the company. This person will function at all levels of bioprocessing and be hands-on to assist with development of validation protocols, optimizes cell and tissue-based processes and leads the implementation of newly developed procedures across the organization. Cross-functional communication and training staff on all operations are critical aspects of this position. Flexibility is very important to being successful in this role.

Duties will include, but are not limited to:

  • Responsibility for coordinating and executing bioproduction steps from process development through technical transfer and ultimately full production.
  • Develop consistent and robust biological processes for the production of tissue-engineered and tissue-based products in R&D and clinical production settings.
  • Lead the Process Development / Engineering team.
  • Develop and execute validation strategies to assure that production processes meet regulatory quality requirements.
  • With our Quality Control and Quality Assurance team, help Implement monitoring assays and sampling protocols.
  • Manage the creation and validation of production metrics.
  • Lead the generation SOPs for technology transfer to clinical production, identify areas where new SOPs are needed, and lead development of those SOPs.
  • Assess bio-process behavior using statistical approaches and use data to set specifications for process control.
  • Oversee and manage installation qualification, operational qualification and performance qualification validation protocols.
  • Generate scientific reports for regulatory strategy and submissions as needed.
  • Human resource leadership and management.
  • Raw materials and in-process Inventory.
  • Financial management and budgeting.
  • Executive level reporting.

Qualifications:

  • PhD and extensive industry experience.
  • Candidate will possess a demonstrated technical foundation of cell- and tissue-based products and bio-process development.
  • Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, process development, and/or cell biology.
  • Highly-motivated and organized.
  • Works and leads well in a team environment.
  • Possess a positive attitude and optimistic outlook.
  • Motivated and organized critical thinker with solid interpersonal and business communication skills.
  • Demonstrated ability to work effectively within a team to set goals, develop sound project plans, monitor progress, and report results scientifically.
  • Routinely communicate findings and information to other team members; transparency and knowledge sharing is expected and practiced.
  • Knowledge and experience with standard and advanced bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment.
  • Familiarity and understanding of basic and/or advanced cGMP compliance in the biotech/bioprocessing manufacturing environment (Knowledge of Code of Federal Regulations 21 CFR 1271.
  • Previous small team management or leadership.
  • Relevant pharma or biotech industry experience.
  • Background in one or more specialties of biotechnology, bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, process development, cell biology, chemical engineering, and/or biochemical engineering.
  • Demonstrated leadership in a broad spectrum of bioprocess applications, leadership and mentoring of staff.
  • Able to troubleshoot and design typical bioprocess optimization studies.
  • Familiar with application of statistics to in process measures of biological systems in a controlled production environment.
  • Extensive cell biology background and tissue culture development experience.
  • Experienced leader of validation studies in a cGMP environment.
  • Possesses firm understanding of equipment and procedures, and identifies potential problems before they occur.
  • Able to train others on theory and concepts behind the process, including an understanding of the impact of on upstream and downstream activities.
  • Able to develop process specs, operating ranges, alert/action limits.
  • Identify areas where new SOPs are needed, and manage development of those SOPs.
  • Skilled in advanced biotechnology processing – integration of major unit operations and microbial control concepts.
  • Identify areas where process development is needed, and perform/lead process development experiments to define specifications.
  • Critical thinker.
  • Able to develop and implement preventative action plans to non-obvious problems, and can confidently deal with corrective actions.
  • Acts as a resource for process development and manufacturing, and participates in strategic process development.
  • Can design, execute and interpret data from targeted experiments with little to no supervision.
  • Effectively communicates high level concepts to both executive and scientific leadership.
  • Strong oral and written and skills. Capable of writing management level reports and summaries.
  • Good written communication skills. Clearly communicates scientific and process issues with co-workers and supervision, and communicates in a timely manner.

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