QC Chemist

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, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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.

This job family is responsible for analytical operations in support of clinical and commercial programs, formulation development, quality control testing to support our GMP operations for Solid Oral Dosage & Biologics Portfolio of Products.

This role resides in the overall QC function and is responsible for QC analytical activities associated with New Product Introduction of Biologic products, solid oral dose products, analytical method development & validation, transfer activities and Process & Cleaning Validation analysis as appropriate. The role will primarily focus on the introduction and ongoing support for Bio-analytical equipment and associated techniques, requiring any candidates to have the necessary analytical experience in this area. It also entails the provision of day to day technical support to operations for deviations, investigations, optimisation programs etc.

Specific Job Responsibilities:

• Analytical support of Method Validation/Transfers for Biological & Solid Oral Dose Products as appropriate with specific emphasis on Biologic/Large molecule activity.
• Execution of process and cleaning validation studies in support of New Product Introductions.
• Provision of technical support to Operations for investigations and optimisation projects.
• Deliver new technologies and continuous improvement initiatives to meet business requirements.
• Lead QC TS investigations/troubleshooting and technical projects within the function.
• Identify new equipment for new product transfers.
• Demonstrates skills in data analysis (ex: CE-SDS. CEX HPLC, SE-HPLC, cIEF, Peptide Mapping, UPLC etc,) and ability to critically evaluate data quality.
• Reviews data and results of testing to ensure compliance to appropriate specifications and protocols.
• Writes and executes protocols and reports.
• Assists in the training of QC staff.
• Writes and revises methods, specifications, and SOP’s as needed.
• May develop methods for performing cleaning validations.
• Knowledge of current Good Laboratory Practices
• Excellent communication skills (both verbal and technical) and strong interpersonal skills
• Executes analysis efficiently, consistently, and with high quality and suggests improvements.
• Acts as a resource for other employees within the department.
• 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.

Skills & Expertise:

• relevant experience in test methods for biologic and biopharmaceutical products
• Strong knowledge and understanding of cGMP, quality control (QC), and regulatory requirements for GMP laboratories in pharmaceutical industry.
• Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
• Hands-on experience with equipment qualification and analytical techniques such as CE-SDS, CEX-HPLC, SE-HPLC, cIEF, Peptide mapping, UPLC/HPLC is essential.
• Knowledge of software such as Empower, SOLO VPE and LIMS.
• Critical thinking skills and ability to solve moderately complex problems and good judgement in making recommendations
• Six sigma tools for root cause analysis
• Lean tools for efficiency optimisations
• Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience
• Ability to work independently and as part of a team with internal and external partners, self-motivation and adaptability

Typical Education & Experience:

• relevant experience with BSc degree in Biopharmaceutical Science, Chemisty or equivalent.
• Bio-analytical testing experience is essential per the techniques already listed

Behaviours

• Resilient & dynamic profile with the ability to deliver in an ambiguous environment
• Ability to engage and manage multiple stakeholders to achieve the objective
• Curious with learning agility
• Operationally excellent
• Organised with systematic approach to prioritisation
• Process orientated to achieve the business objective

Gilead Core Values

• Integrity (always doing the right thing),
• Teamwork (collaborating in good faith),
• Excellence (working at a high level of commitment and capability)
• Accountability (taking personal responsibility).
• Inclusion (encouraging diversity)

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 apply via the Internal Career Opportunities portal in Workday.