Director - Cell Culture, Product Development in Cranbury Township, NJ at Apex Life Sciences

Date Posted: 8/9/2018

Job Snapshot

Job Description


Position Responsibilities:

  • Interface with cell and molecular biology team with development approach and strategy.
  • Serve as subject matter expert related to upstream process development including all process and manufacturing related activities such as risk assessments, characterization, investigations, regulatory interactions, and project team requirements.
  • Build a high performing group focused on execution, data analysis.
  • Mentor technical and junior staff to understand technical and regulatory requirements for process development.
  • Support upstream process control strategy for monoclonal antibodies manufacturing processes.
  • Oversee the execution of upstream process characterization studies.
  • Support tech transfer to manufacturing through authoring and change management of process descriptions (TTPs)
  • Plan and conduct experiments to define upstream manufacturing process parameters or optimized media formulations.
  • Establish and qualify appropriate scale-down models to support process characterization
  • Collaborates effectively within Process Development as well as with Manufacturing, Quality Control, Quality Assurance and Regulatory Affairs.
  • Evaluate opportunities for improving process robustness or reducing Cost of Goods through process optimization
  • Lead development of 2nd generation processes for implementation post-approval
  • Author appropriate CTD sections for submission to regulatory agencies, including premarket notification submissions, premarket approval applications, and post-marketing submissions
  • Build department of scientific excellence to enable prosecution of mAb biosimilar pipeline as well as other projects that may be assigned
  • Represent the Company before EU and FDA regulatory authorities

Education/Certification

  • M.S. or Ph.D. in Chemical Engineering, Life Sciences or equivalent

Qualifications and Skills

  • 10+ years progressive industry experience with biologics late phase process development and validation
  • Experience in biotechnology drug development, with clear understanding of CMC requirements
  • Ability to support and effectively multi-task different and complex assignments and responsibilities
  • Understand, identify, mitigate, and communicate risks at the program level
  • Experience with development of mammalian cell lines along with knowledge of filtration principles and capacity determination
  • Experience in authoring a BLA/MAA which resulted in approval and marketed product support
  • Experience with statistical methodologies such as DOE, process control charting, multivariate analysis
  • Experience with mAbs or similar biologics manufactured utilizing single-use technology is strongly desired
  • Strong understanding of Quality by Design and Risk Management
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration
  • Due to international nature of the tasks, fluency in written and spoken English
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in teams
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done
  • Well-organized and accustomed to changing priorities and maintaining excellent records

For immediate consideration, email your resume to ESchaffer@apexlifesciences.com with the subject 'Director- Cell Culture, Product Development'

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.