Associate Director, Pilot Plant Operations

仕事内容

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Gilead Sciences currently has an excellent opportunity for a highly motivated scientist to join our Active Pharmaceutical Ingredient (API) Pilot Plant Operations group in the Pharmaceutical Development & Manufacturing (PDM) organization. With your commitment and drive, you will be part of a cross-functional drug development team whose goal is to develop curative medicines helping millions of people live healthier, more fulfilling lives. The API Pilot Plant Operations team manages state-of-the-art manufacturing facilities in which we manufacture small molecule APIs for clinical trials. Critical to the success of this role will be partnering with the scientists of the Process Chemistry team to execute safe, flexible, and compliant manufacturing.

Essential Duties and Job Functions:

· Responsible for safe, flexible, and compliant manufacture of drug substances in GMP facilities.

· Address environmental, quality, and safety concerns.

· Coordinates production schedules based on project priorities.

· Ensures appropriate change management and qualification of new and upgraded equipment.

· Ensures manufacturing areas, equipment, and procedures meet all current regulatory requirements.

· Contributes to authoring of and reviewing pre- and post-execution batch production records.

· Identify and implement cost reductions in materials, equipment, or overhead.

· Supervision of manufacturing staff.

· Advise members of project teams in the design and execution of API manufacturing, considering economic, sustainability, regulatory and safety factors.

· Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.

· Demonstrate excellent verbal communication skills and interpersonal skills.

· Demonstrate collaborative communication and problem-solving spirit.

· Management of calibration and maintenance activities using a computerized maintenance management system (CMMS).

· Author, review, and approve quality documents (Deviations, Change Controls, Impact Assessments, etc.) in a quality document management system.

Knowledge, Experience and Skills:

· PhD in Organic Chemistry (or related discipline) 2+ years of relevant experience, OR MS degree with 8+ years of relevant experience, OR BS degree with 10+ years of experience.

· Understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP).

· Experience in planning and executing small molecule cGMP manufacturing.

· Demonstrated ability to work in multi-disciplinary teams, learn new skills, and proactively solve problems.

· Familiarity with continuous quality improvement methodologies such as Lean Six Sigma, Kaizen, and 5S

The salary range for this position is: $177,905.00 - $230,230.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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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 ApplicantAccommodations@gilead.com for assistance.

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