Senior Manager External Manufacturing
Senior Manager External Manufacturing
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
['The Senior Manager External Manufacturing is responsible for the supplier relationship and performance management of assigned commercial drug product contract manufacturing organizations (CMOs). This position coordinates between all relevant Gilead functions and CMO functions to ensure strategies and supply plans are executed and achieved as planned. This includes driving performance of the strategic relationship under the direction of the department Director and in conjunction with Commercial Manufacturing, Analytical Operations, Quality, Supply Chain, Development and other Gilead functions, as needed. This position will lead the respective CMO Management Teams for assigned CMOs and support implementation and execution of CMO initiatives as part of the larger Gilead CMO governance model. This person will also work with CMO management to measure performance KPIs and drive results and initiatives, and to develop and maintain collaborative relationships.
This position will also support metrics, initiatives, and activities that span Gilead's full commercial drug product CMO network (25+ sites), including but not limited to aggregation and reporting of network performance measures, network spend analysis, network capacity analyses, and department system and process improvements.
Essential Duties and Job Functions:
- Serve as the primary day to day contact to support the relationship between Gilead and assigned CMOs.
- Manage and mitigate supply issues at CMOs and drive robust supply of product through coordination across commercial functions.
- Manage external manufacturing activities and relationships. Serve as the day to day internal representative for CMO management at assigned CMOs.
- Execute strategies that drive effective operational performance and service levels at CMOs. Strong alignment with Supply Chain, Commercial Manufacturing, and Quality is required.
- Lead initiatives that drive a collaborative and robust relationship and drive alignment between CMOs and Gilead including but not limited to: Business reviews, Performance Metrics, Continuous Improvement projects, and Risk Management.
- Support and effectively execute CMO Management initiatives and cross functional efforts, processes and strategies to ensure supply performance is achieved, both at the CMO and within Gilead.
- Utilize analytical tools to identify, quantify, and minimize risks at assigned CMOs
- Negotiate and manage key CMO agreements (MSAs, SOWs, Supply Agreements, Pricing, etc.)
- Implement and manage joint operating procedures between Gilead and the supplier/CMO to ensure effective execution.
- Understand the CMO market and capabilities that are consistent with Gilead's manufacturing requirements. Develop relationships with potential CMOs that support Gilead's future CMO needs
- Coordinate interdepartmental activities with Quality Assurance, Manufacturing, Development and other functions that support commercial supply.
- Work closely with department management to establish standards and policies that support key CMO/supplier partnerships.
- BA/BS with 8+ years of relevant experience in a related field or a MBA or MS plus 6+ years of relevant experience in a related field
- Prior experience managing contract manufacturing highly desirable
- Prior experience in pharmaceutical operations and cGMP environment(s) highly desirable
- Ability to influence and work well with others in a proactive and constructive manner.
- Strong communication skills, both verbal and written, with all levels of an organization
- An independent self-starter with the ability to resolve supplier performance challenges and implement process and/or system improvements
- Ability to develop, analyze, and leverage key metrics to improve overall business performance
- Proven ability to problem solve, build strong relationships, and to organize effectively
- Business acumen with an ability to anticipate operational issues and proactively recommend mitigations/solutions
- Expertise in domestic and international cGMPs
- Demonstrated ability to multi-task and to work across multiple multi-national sites and diverse cultures
- BS degree in related field required. Advanced degree including MBA or MS preferred
- Familiarity with ERP and supply chain systems a plus
- Travel required - up to 20%
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
About 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.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. 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.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Senior-Manager-External-Manufacturing_R0022427
Copyright 2021 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency