Lead Manufacturing Specialist

Menlo Park, CA 94025

Posted: 07/02/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 16000

Lead Manufacturing Specialist

Menlo Park, CA

 

We are currently  looking to bring onboard a Lead Manufacturing Specialist to help support the manufacturing and commercialization of our AAV vectors.

Responsibilities (include but are not limited to):
  • Oversee the manufacturing of AAV based viral vectors encompassing the entire process from thaw to final formulation, internally and at CMOs
  • Provide hands on support for upstream and downstream manufacturing, including Person-in-Plant support
  • Provide training and ongoing coaching, discipline and recognition of staff
  • Author and review technical documentation including SOPs, batch records, tech transfer protocols, campaign summaries, and risk assessments
  • Execute production and resource schedule against operational plan
  • Ensure performance of all process steps specific to the phase or stage of operation (e.g. upstream, downstream, support)
  • Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements
  • Complete the final review of completed manufacturing documentation per compliance standards and established timelines to support lot release,
  • Lead key investigations related to process deviations, take ownership of CAPAs,
  • Investigate and resolve problems, identifying root cause, and proposing process improvements to support GMP manufacturing
  • Interact and build relationships with outside vendors and CMO’ s
  • Participate in multi-functional project teams, as necessary
  • Take corrective action to bring about required changes using change control procedures

Requirements:
  • Master’ s degree with 6 years of industry experience or bachelor’ s degree w/ 8 years industry experience in a GMP environment
  • Able to build a team as well as train entry-level personnel
  • Sufficient understanding of process, systems and equipment to troubleshoot problems and provide solutions
  • Sufficient knowledge of quality systems and escalation process
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Ability to adapt in a constantly evolving environment
  • Self-motivated with a strong sense of ownership in areas of responsibility
  • Previous GMP cell culture experience and protein purification is required
  • Team management experience is a plus
  • Travel - Overall travel is 25%,

 
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