Manufacturing Specialist

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's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide.  As a (Manufacturing Specialist), you are responsible for:

Key Responsibilities:  

• Demonstrates hands-on technical leadership of process development, technology transfer, and process operations within a phase appropriate cGMP environment.
• Responsible for executing technology/process transfer from Lab to manufacturing production floor and provide technical input and support during manufacturing of drug products.
• Lead the design and development of downstream processes, including design of experiments, process optimization, data interpretation and analysis. 
• Author or review technical documentation (development reports, process description, process flow protocols, batch records, etc) 
• Mentor junior team members on process operations and development strategies, experimental design and execution as well as process transfer.  
• Participate in cross functional initiatives,
• Adhere to department budget and all training, compliance, and safety requirements.

Basic Qualifications:  

M.S. with 2+ years or BS with 4+ years’ experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering). 

Preferred Qualifications:  

• Strong understanding of biologics/sterile injectable product manufacturing processes e.g., bulk freeze/thaw, mixing/pooling, filtration, filling and/or lyophilization
• Experience supporting drug product manufacturing operations, technology transfer, and/or development.  Prior experience with commercial manufacturing and/or process validation is highly desirable.

• Hands-on experience with process operations including centrifugation, normal flow filtration, high throughput purification screening and development, chromatography operations, tangential flow filtration, formulation development and technical transfer. 
• Broad understanding of downstream development and scale up including process transfers for new product introduction into the production lines.
• Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities. 
• Working knowledge of cGMPs and regulatory requirements of biopharmaceutical manufacturing
• Experience in cleaning process design, verification, and cross contamination strategies.
• Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills

 

The salary range for this position is: $107,185.00 - $138,710.00. 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*.

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