Senior Packaging Engineer II
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POST DATE 8/10/2016
END DATE 1/13/2017
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
* Collaborate with Formulation and Process Development, Clinical Labeling, Clinical Supply Management, Clinical Operations, and Outsourced Manufacturing to determine optimal packaging configuration(s) and phase appropriate packaging site(s) for clinical programs.
* Create packaging development timelines and lead packaging activities in support of multiple clinical programs in all phases of development, ensuring on-time delivery of project deliverables and compliance to Good Manufacturing Practice (GMP).
* Execute packaging equipment and process verification and validation (including IQ/OQ/PQ) to prove effectiveness of new packaging configurations and/or packaging lines / sites.
* Support packaging operations remotely and on-site and drive expeditious and appropriate resolution of deviations and investigations as necessary.
* Identify and deliver new packaging engineering solutions that meet business needs related to tablets, parenterals, and biologics.
* Perform characterization and qualification of packaging components (bottles, blisters, vials, prefilled syringes, caps, stoppers, etc.).
* Write and review SOPs related to clinical packaging engineering, ensuring alignment with other Gilead SOPs and specifically Commercial Packaging and Labeling procedures.
* Lead specific components of departmental strategic initiatives.
* Design and write packaging study protocols and reports that support product development and regulatory filing needs.
* Write sections of global regulatory filings related to packaging / container closure.
* Train new employees in SOPs and documentation systems.
* Overnight travel may be required up to 25% of time.
ESSENTIAL DUTIES AND JOB FUNCTIONS
* Excellent technical skills and knowledge of packaging engineering and package development methodologies is required, preferably in both biologics and traditional pharmaceuticals (e.g. solid dosage, oral powders, suspensions, small molecule parenterals).
* Strong knowledge of FDA and cGMP standards as well as regulatory guidance documents such as Annex 16 is required.
* Strong verbal, written, and interpersonal communication skills are required.
* Strong computer and organizational skills are required.
* Experience collaborating with CMOs is highly desirable.
KNOWLEDGE, EXPERIENCE AND SKILLS
* B.S. degree in packaging engineering, mechanical engineering, or a related scientific field and a minimum of 7 years of relevant industry experience. Advanced degree(s) with commensurate industry experience are also considered.
* Prior experience and deep knowledge of a cGMP-related industry is highly desirable.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
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