Upstream Process Engineer

Azzur Group San Francisco is looking for Senior Upstream Process Engineer to join our team. Working with a multi-disciplinary team, the Sr process engineer ensures fulfillment of process characterization for our client according to the established plan. In this hands-on role, the Sr. process engineer is the key liaison between clients product and CMO, and will be responsible for the quality of work produced by their team. Experience with cGMP and FDA compliance is essential.

Essential Duties and Responsibilities

• Function as SME and lead technical team at CMDO for late phase recombinant protein drug development for both Drug Substance and Drug Product, including tech transfer, scale up, gap/risk analysis, process characterization/qualification, cGMP manufacturing.
• Provide technical guidance and keep project on time and in compliance with cGMP regulations.
• Review and approve controlled documents including batch records, SOPs, protocols, and reports related to process development and characterization.
• Work closely with QA/QC to identify and evaluate deviations, CAPA and change control.
• Lead and direct the work of our partner organizations and consultants. Build strong communications and relationships with partner organizations and consultants.
• Ensure compliance with both internal clients process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.
• Collaborate with CDMO for health authority inspection.
• Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.
• Actively participate as member of clients representative supporting product and new business development.
• Participate for US and International specific documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements.

Required Experience

• BS Engineering or related discipline.
• Minimum 10 years process engineering experience in the upstream pharmaceutical and/or biotechnology industry is required.
• Experience with FDA compliance and cGMP is required.
• Must be results oriented with several years of hands-on experience, familiar with industry concepts, practices and procedures in a cGMP environment.
• Must have experience reviewing batch record
• Must have experience working with CHO
• Excellent verbal, oral, and technical writing communication skills.
• Proficient in Microsoft Word, Excel, Power Point, and able to quickly learn new computer applications.

Azzur Core Values:

Puts Others First...Have the Courage to Take Action…Take Personal Responsibilities…Have Fun!

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