Technical Transfer Project Manager
Technical Transfer Project Manager
Russian Federation - Moscow
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. Gilead’s 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 company’s five core values. That’s 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
Technical Transfer Project Manager:
The technical transfer project manager position resides in the Commercial Manufacturing organization at Gilead Sciences. The Commercial Manufacturing team is responsible for supporting product manufacturing technology transfer, equipment procurement and packaging projects at contract manufacturing organizations. This role will be based in Moscow, Russia and will support technology transfer projects to CMOs in Russia.
Specific Job Requirements:
- Act as project manager for technology transfer project for oral solid dose (tablet) manufacturing to contract manufacturing organizations (CMOs). Acts as liaison between Gilead Foster City, Gilead Russia and CMO site.
- Facilitate meetings and tele-conference with CMO, equipment manufacturers and Gilead.
- Manage and distribute meeting agenda, meeting notes, track project schedules and deliverables. Provide timely and relevant updates to the team.
- Act as Gilead representative during design reviews, Factory Acceptance Tests, Site Acceptance Tests, equipment trials, performance qualifications and process validations.
- Review relevant documents such as User Requirement Specifications, CMO documents such as change control, batch records, specifications, protocols, reports, etc. and provide feedback.
- Provide technical leadership in the areas of pharmaceutical manufacturing, package engineering, identifying solutions to meet stakeholder needs, partnering with suppliers and CMOs, and driving manufacturing solutions.
- With an understanding of local regulations, CMO site requirements and Gilead requirements, provide guidance to equipment manufacturer.
- Work collaboratively with cross functional areas to meet complex project deliverables and ensure on-time delivery of project deliverables. Ensure product meets regulatory, performance, and cost requirements and maintain compliance to current Good Manufacturing Practices (cGMP).
- With minimal guidance, determines the functions most critical to project success and supports priorities accordingly.
- Contributes to and may lead technical investigations and assessment of deviations.
- Overnight travel may be required up to 25% of time.
Education and Experience:
- BS or MS degree in a science field, mechanical engineering, biomedical engineering, chemical engineering, or a related scientific field and a minimum of 6 years of relevant industry experience is required. Advanced degree(s) with commensurate industry experience are also considered.
- Prior experience in pharmaceutical industry is required with knowledge of oral solid dose manufacturing is preferred. Knowledge of Russian regulations and cGMP is required
- Strong verbal, written, and interpersonal communication skills are required. Dual language (Russian and English) skills are required.
- Strong computer, organizational, and project management skills are required.
- Experience collaborating with external suppliers, CMOs, or contract test laboratories is desirable.
- Detailed understanding of equipment qualification and process validation is required.
- Knowledge of tablet manufacturing processes such as blending, milling, granulation, compression and, coating processes is preferred.
- Knowledge of packaging equipment, packaging components, packaging process including primary, secondary and tertiary packaging, and Russia serialization requirements is desirable.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
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/Russian-Federation---Moscow/Technical-Transfer-Project-Manager_R0016010
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