Provide non-routine project coordination, working closely with external groups (IMP, QA) and laboratory SME's to ensure highest level of compliance, uninterrupted supply to patient, and continuous improvement in business processes and methods
Represent QC Micro to customers and cross functional teams
Apply working knowledge of compendial requirements and pharmaceutical industry standards
Ensure QC Micro is ready to support clinical and commercial manufacturing campaigns, for both routine and non routine tasks (i.e Method Suitability completion prior to routine sample arrival)
Review and approve documentation for clinical campaigns
Ensure effective corrective and preventive actions are systematically identified, analyzed, implemented and documented to prevent recurring problems and improve product and process quality
Job Duties/Responsibilities:
Perform routine microbiological testing of raw materials, E.coli and mammalian cell banks, commercial and clinical fermentation, purification and final product samples to meet standard lead times
Coordinate non-routine microbiological studies, from request to report, in support of the clinical pipeline (i.e. meet project deadlines to support of filings)
Prioritize and schedule non-routine projects with competing priorities. In addition, clearly communicate and project future work to applicable personnel/groups
Maintain and apply working knowledge of compendial requirements and current pharmaceutical industry standards
Understand and apply knowledge of manufacturing processes and regulatory commitments to daily tasks
Communicate clearly and effectively with customers and external groups on tight timelines for high visibility/high impact projects
Apply extensive theoretical and cross-functional expertise in the context of company objectives to independently address complex problems
Participate in assay, facility and equipment process validation
Review data and assess against established acceptance criteria
Identify and resolve deviations and/or discrepancies
Identify, troubleshoot, and solve technical problems, including identification of process gaps and improvements
Assure and apply cGMP throughout operations
Meets scheduled performance of 95% on time
Perform other duties as requested by managers to support QC Micro activities
Represents organization as a primary contact on QC Micro nonroutine projects
Who You Are Qualifications/Requirements:
Experience with microbiological testing such as Bioburden, PCR, LAL, Non Host, Phage and Sterility
Ability to communicate clearly, in writing and verbally, with peers, upper management and with external individuals both locally and globally
Strong grasp and understanding of scientific theories, principles, and techniques used in biological and analystical test procedures
Thorough understanding of basic microbiological compendial requirements and pharmaceutical industry standards. Experience with application of compendial requirements is preferred
Ability to exercise sound judgment, reasoning, problem solving and decision making
Independently capable to design, execute, interpret and review results
Ability to work off-shift, weekends and holidays, as needed
Proficient in computer software such as Microsoft Office, SAP and Labware LIMs. Experience with additional software that can be applicable to improving current systems is preferred
Experience and ability to work with bacterial and fungal cultures
Ability to sit, stand and work within work space for extended periods of time
Education:
BS degree in Microbiology or related field
Experience:
Associate I: 0 to 2 years of microbiological pharmaceutical experience
Associate II: 2 to 4 years of microbiological pharmaceutical experience
The next step is yours. To apply today, click on the "Apply online" button below.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity protections, view the EEO is the Law poster.
If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com .
Genentech - 2 days ago- save job
174 reviews
Genentech, Inc. (Genentech) is a biotechnology company that discovers, develops, manufactures and commercializes pharmaceutical products to...
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