Location: 
South San Francisco
Employment Type: 
Contract
Job ID: 
134054
Description: 

Essential Duties

Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
Lead and/or participate in global initiatives and cross-functional investigation and project teams
Work collaboratively with Global Manufacturing Science and Technology (gMSAT) groups to develop and communicate best practices for process and equipment design and operation to ensure consistency and compliance across the biologics manufacturing network

 
 

Provide leadership as the business process owner for the management of multi-site vendor initiated changes (VICs) impacting single-use technologies

Assist supplier quality groups as a technical assessor for VICs
Provide guidance to the global manufacturing network in order to assure consistent and timely VIC assessments are delivered
Develop training materials and provide training sessions as needed
Define metrics to monitor the business process performance in order to recommend future improvements
Expand the implementation of the multi-site business process to account for material categories other than the single-use category
Represent GBMSAT and the single-use category in meetings such as the Material Review Board (MRB) and the Single-Use Category Team (SUCat) and Supplier Quality Management (SQM) meetings as required

Support single-use technologies at manufacturing sites

Define the current state of SUT conformance compared to standards
Identify gaps and propose a remediation plan to mitigate potential compliance risks
Align VIC management practices with internal Roche standards and multi-site VIC processes
Support technology transfers, audits, and regulatory filings pertaining to new and existing SUT items (e.g. antifoam bags, bioreactors, tubing sets, sampling containers, etc.)
 

Skills:

Self-motivated, able to work independently as well as in teams. Excellent organizational and communication skills (both written and verbal)
Demonstrated proficiency in leading teams, experience leading cross-functional or cross-site teams is a plus
Proven ability to influence beyond direct line reporting relationships including to senior management
Experience with change control is required
Strong problem-solving and troubleshooting skills to support polymer chemistry analysis
Full working knowledge and experience with Single-Use equipment qualification, design and operation is a plus

Education:

BS/MS/PhD. in Chemical/ Biochemical Engineering or Life Sciences with at least 3-5 years of relevant industrial experience or academia (including advanced studies) after receiving Bachelor’s degree

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