Director, Cell Research - Job # 2335

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:

This incumbent will be responsible for leading and directing the cell isolation, cell process development team and cell research teams.

The successful candidate will:

  • Design and lead cellular research programs, including cell characterization, cell growth optimization, cell identity.
  • Develop and lead robust large scale mammalian cell culture processes for the production of tissue-engineered products.
  • Lead the Cell research and cell process development teams.
  • Develop and execute validation strategies to assure that processes meet regulatory quality requirements.
  • Generate SOPs for technology transfer to clinical production, identify areas where new SOPs are needed, and manage development of those SOPs.
  • Generate scientific reports for regulatory strategy and submissions as needed.
  • Present results and recommendations to the team in order to help the company make strategic decisions.
  • Leadership and management.
  • Operating budget management.
  • Executive level reporting.
  • Must be an industry veteran, who has functioned at all levels of cell research and culture and is on hand to assist with development of cell research programs including cell isolation, cell characterization and large scale cell culture processes. Cross-functional communication and training staff are critical aspects of this position. Flexibility is very important to being a successful applicant for this position.
  • Demonstrated leadership in a broad spectrum of cell applications, leadership and mentoring of small staff (5-7 team members and contract manufacturer).
  • Cross-disciplinary expertise, ideally including a combination of cell, tissue engineering and cGMP manufacturing and/or industrial research experience.
  • Expertise in primary vascular cell isolation and mammalian cell culture, ideally smooth muscle cells.
  • Expertise in mammalian cell characterization such as, cell growth, cell identity, and cell function.
  • Expertise in molecular biology techniques, including RNA and DNA isolation, purification, quantification and analysis.
  • Experience with cell culture process development, including efficient scale up, media optimization, and characterization studies.
  • Intellectual property development and documentation experience is a plus.

Qualifications:

  • PhD and extensive industry experience in Cell biology or Molecular Biology or related areas.
  • Candidate will possess a demonstrated technical foundation of cell based products.
  • Highly-motivated and organized.
  • Works and leads well in a team environment.
  • Problem Solving.
  • 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 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.
  • 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 ccommunicate findings and information to other team members; transparency and knowledge sharing is expected and practiced.
  • Knowledge and experience with standard 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 a plus.
  • Previous small team management or leadership.
  • Relevant pharma or biotech industry experience.
  • Background in one or more specialties of cell biology, vascular biology, molecular biology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, process development.

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