Cell and Gene Therapy Development Manager

1 day ago

Singapore beBeeSpecialist Full time $150,000 - $200,000
Cell and Gene Therapy Specialist">

The Opportunity:

We are seeking a highly skilled Cell and Gene Therapy Specialist to join our team. This is an exciting opportunity to be part of a dynamic organization that is revolutionizing the field of cell and gene therapy.

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Job Description:

As a Cell and Gene Therapy Specialist, you will be responsible for leading cross-functional teams in the development and execution of cell and gene therapy programs. You will work closely with internal and external stakeholders to maintain customer processes in our cGMP facility and oversee the strategic direction of our therapeutic pipeline.

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Key Responsibilities:

  • ">
  • Lead cross-functional biotechnicians in the development and execution of cell and gene therapy programs">
  • Collaborate with commercial teams to ensure launch readiness and market access">
  • Serve as Subject Matter Expert during audits and due diligence activities">
  • Support sales, business development, product specialists, and associated departments as Subject Matter Expert">
  • Modify or improve procedures as necessary to optimize departmental workflows">
  • Author, review and edit relevant documents, including SOPs, Risk Assessments and Technology Transfer Protocols, Electronic Batch Records and other cGMP documents">
  • Conduct periodic technical reviews of Master Match Records (MBRs), including completed MBRs">
  • Maintain a focus on customer and/or patient needs to facilitate technology transfer and batch execution">
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Requirements:

  • ">
  • Minimum Bachelor's Degree in Chemical Engineering, Pharmaceutical Science or relevant discipline with 2 years or more experience in a cGMP/aseptic environment in cell and gene therapy">
  • Minimum of 2 years in cGMP cell and gene therapy manufacturing with relevant industry knowledge, hands-on equipment experience and technical expertise">
  • Proven track record in regulatory strategy and interactions">
  • Strong knowledge of cGMP practices and global regulatory requirements">
  • Experience in bringing cell and gene therapy products through clinical development to market">
  • In-depth knowledge of the drug development process and commercialization pathways">
  • Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel)">
  • Able to work independently and task oriented in a dynamic environment">
  • Strong team player with a strong set of interpersonal skills">
  • Excellent written and verbal communication skills">
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Benefits:

  • ">
  • Competitive compensation package">
  • Opportunities for professional growth and development">
  • Collaborative and dynamic work environment">
  • State-of-the-art facilities and equipment">
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Other Opportunities:

  • ">
  • Collaborate with cross-functional teams to develop and execute cell and gene therapy programs">
  • Work with internal and external stakeholders to maintain customer processes in our cGMP facility">
  • Oversee the strategic direction of our therapeutic pipeline">
  • Develop and implement quality control and assurance procedures">
"],

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