Senior Packaging Engineer - South San Francisco, CA | Biospace
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Senior Packaging Engineer

Portola Pharmaceuticals, Inc.

Location:
South San Francisco, CA
Posted Date:
9/15/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Engineering,

Job Description


Portola Pharmaceuticals is a biopharmaceutical company, headquartered in South San Francisco developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company’s first medicine Bevyxxa® (betrixaban), an oral, once-daily Factor Xa inhibitor, was approved by the U.S. Food and Drug Administration in June 2017. The company is also working to advance two clinical programs for AndexXa® (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a SYK/JAK inhibitor in development to treat hematologic cancers. Portola's partnered program is focused on developing selective SYK inhibitors for inflammatory conditions. These compounds come from our own internal research efforts and represent important advances to address significant unmet needs.

Role Profile:

The Senior Packaging Engineer will support the identification of primary, secondary and tertiary package components, materials, and delivery systems for company products and will support key commercial packaging and labeling operations.  This position requires a demonstrated ability in designing packaging specifications, developing packaging batch records, qualifying and validating packaging processes, and resolving technical issues with component suppliers and contractor facilities.  The Senior Packaging Engineer requires thorough knowledge and demonstrated experience in package design and development for distribution cycle and thermal package testing, and an acute understanding of regulatory requirements and industry trends for controlled environment shipments.  The person will work closely with colleagues from the Manufacturing, Supply Chain, Pharmaceutical Development, Quality Assurance, Regulatory Affairs, Project Management, and Marketing groups and staff from other functional areas, to meet complex deliverables such as new product launches or start-up of new manufacturing sites while ensuring an uninterrupted commercial product supply.  In addition the person will participate in the introduction of process improvements, maintain relevant metrics for all packaging projects/operations, trouble-shooting of process-related issues and will support root cause analysis of packaging deviations.   This person will also be responsible for managing the process of developing, reviewing, and approving commercial labeling components.

Responsibilities:

•   Support component design and material selection; source, obtain quotes, and negotiate per desired specifications; evaluate submissions with team and management for approval
•   Collaborate with Pharmaceutical Development, Regulatory, Supply Chain, Quality, and other departments to oversee and meet all packaging technical and operation activities, including but not limited to; regulatory requirement submissions, engineering studies and line qualification, storage and distribution testing and USP Testing, to ensure a robust supply of commercial product supply to patients
•   Maintain strong partnerships with external suppliers of packaging operations, materials, and services for development and commercial products
•   Acts as the Person-In-Plant (PIP) to provide Portola oversight of CMO Packaging and Labeling activities, including line trials, line qualification process validation
•   Ensure packaging solutions are in compliance with international regulations and adherence to relevant quality directives, procedures, guidelines and global standard processes
•   Support end-to-end packaging validation activities and be responsible for authoring and reviewing packaging qualification and validation documents
•   Oversee the Labeling Operations function for developing, reviewing, and approving commercial labeling; this includes working with and overseeing internal or external staff functions for a Graphic Designer and Technical Editor/Proof-reader
•   Track deviations and process/operational changes; ensure appropriate technical and management visibility within Portola to these events and facilitate feedback and decisions to the CMO
•   Support CMO packaging and labeling operations including master batch creation, batch record review and commercial batch disposition
•   Work semi-autonomously on complex tasks or several parallel tasks and projects and met deadlines
•   Undertake measures to achieve project goals in the event of deviations from the project plan, may exercise judgment in selecting methods, techniques and evaluation criteria for obtaining results and works on complex issues where analysis of situations and data requires in-depth knowledge and understanding of the organization
•   Support external quality and global procurement with the selection and qualification of globally relevant suppliers
•   Assess process and activity gaps and propose plans to mitigate; identify and implement new technologies/packaging processes for improved efficiencies and/or cost savings
•   Develop platform solutions anticipating future business needs
•   Keep management informed of any significant risks to CMC timelines and/or budgets relating to Packaging and Labeling
•   Travel required: 15-20%

Requirements


Qualifications:

•   Bachelor's degree in Packaging, Mechanical Engineering, or related technological field  
•   Minimum 5 years’ experience in supporting commercial packaging operations for parenteral drug and both solid and liquid oral dosage forms
•   Demonstrated leadership in a wide range of packaging related technologies with strong fundamental knowledge of primary and secondary packaging systems & processes, and quality systems
•   Working knowledge of equipment IQ, OQ, and PQ and development of qualification protocols / reports for packaging and shipping qualification activities
•   Expertise in biologic and solid dose packaging disciplines: materials, bottle and closure systems, blister packaging, design of secondary and tertiary components, component compatibility, component qualification, equipment installation and qualification
•   Knowledge of cGMPs and associated regulatory considerations in a commercial pharmaceutical packaging environment
•   Understanding of the development and maintenance of packaging specifications.
•   Knowledge regarding design control, documentation, risk management and processes such as MRD, DIR, FMEA, design verification, and URS.
•   A track record of successfully managing multiple projects within a cGMP related environment
•   Ability to manage timelines and prioritize task execution based on business need ; solution-driven self-starter
•   Excellent organizational, project management, technical, problem solving and communication (written & verbal) skills
•   Ability to think both strategically and tactically with exceptional attention to detail
•   Demonstrated ability to manage multiple high-priority projects concurrently in an often changing environment
•   Able to work with a range of technically and culturally diverse people, influencing them to get the job done, and delivering value-added business results that meet high quality requirements within a tight schedule
•   Awareness of resources and best practices across the pharmaceutical packaging industry, and a track record of managing outsourced packaging and labeling operations

Additional Information:

•   Our company overview and history:  http://www.portola.com/Company-Overview
•   Please include a cover letter that highlights your qualifications and matches our requirements and send resume
•   Recruiters:  Please click this link for more information:  http://www.portola.com/Recruiters-and-Vendors