Senior Scientist, Upstream Process Development

ClinicalPro is seeking a Senior Scientist, Upstream Process Development for a leading organisation specialising in large Molecule research located in the USA.

This individual will be responsible for facilitating the early-stage manufacture of complicated large-molecule biotherapeutics, including upstream cell culture operations.

Must be eligible to work in the USA.

Responsibilities

• Directing a group of researchers and scientists for upstream development operations; assisting with coaching and mentoring.
• To advance clinical stage CMC programmes, and oversee experimental, tech transfer, and manufacturing support operations.
• Write or evaluate sections of regulatory filings and answers to requests from health authorities that are pertinent to CMC.
• Participate in efforts to create, manage, and/or finish innovation initiatives that strengthen & establish platform manufacturing processes and enhance technological skills.
• Track team progress in relation to project timeframes, produce frequent status updates, and inform leadership of any difficulties and resource needs.
• Encourage effective partnerships with stakeholders in technical development (analytical sciences, chemical, device, and drug product technologies, and CMC integration), quality, and manufacturing sciences.
• Support Upstream Process Development on cross-functional projects, including developing strategies and best practices and giving partners feedback.
• Design, installation, and management of a new process or analytical equipment assessment.
• Produce experimental report documentation in support of technology transfer and regulatory filings (technical report writing).
• Attend scientific conferences and training sessions to learn about industry best practices.

Skills and Requirements

• PhD in biology, biochemistry, chemical engineering, or a similar scientific field.
• Six years’ experience developing cell cultures.
• A BS/MS with ten years of experience.
• Strong grasp of micro, bench-scale, and pilot-scale bioreactor operations.
• A track record of successfully directing scale-up and tech transfer initiatives.
• Representing bioprocess functions in cross-functional teams and collaborating with CMOs.
• Ability to communicate with internal and external partners.
• Demonstrated ability for taking the initiative and displaying originality and creativity in problem-solving.

Apply

If you’re interested in this position, apply now to send us an updated copy of your CV, or give us a call right away.

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