Biologics Technical Writer
United States - California - Oceanside
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 #CreatingPossibleFor Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.Job Description
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.Role and Responsibilities:
MFG Team Lead supports clinical manufacturing operations through technical writing and document generation, project leadership, and operational floor support under cGMP conditions. It requires effective written and oral communication skills, root cause analysis (RCA) and incident investigation, and a strong working understanding of biologics drug substance downstream purification operations. The lead may serve as a project lead on cross functional projects or serve as a team representative on cross-functional projects.Responsibilities include:
This is a 4/10 daytime shift Knowledge, Experience and Skills:
- Safety and Compliance are the two primary objectives for this role.
- Create and edit cGMP documents and templates with accurate descriptions and change justification working with assistance from cross-functional departments
- Author/update Standard Operating Procedures (SOP's), Master Batch Records (MBR's), work instructions, and memos
- Manage and own quality system records including deviations, Corrective and Preventive Actions (CAPA), change controls, etc.
- Comprehension of execution for all operations associated with: solution and buffer preparation, cleaning and sterilization of process equipment, operation of manual and automated purification systems (chromatography, tangential flow filtration, virus retentive filtration, depth filtration, and drug substance formulation).
- Understanding of Clean in Place (CIP) and Steam in Place (SIP) of fixed tanks/vessels/portable equipment and Clean Out of Place (COP)/Glass-wash of misc. parts / equipment and autoclaves and analytical testing to support and monitor the processes
- In-depth understanding of DeltaV Automation Systems
- Interface with the Quality Assurance, Maintenance, Process Development, Technical Operations, Automation, Materials Management, and Validation departments on daily operations and projects.
- Regular review of documentation including batch records, logbooks, and forms.
- Support continuous improvement initiatives. Recommends studies to support improvements.
- Utilize ERP systems (Oracle EBS, SAP, etc.) for work order generation and inventory management of consumables, raw materials, and in-process materials.
- Utilize equipment/asset management systems to track and submit service requests.
- Provide support to internal and regulatory audits
- Lead or serve as a functional representative on cross-functional projects
- 6+ years of experience with Bachelor's degree or 4+ years with Masters in science, engineering or related field is required
- Prior experience in a Current Good Manufacturing Practices (cGMP) environment is required
- Demonstrated leadership experience
- Excellent technical competency in purification equipment and prior experience with biopharmaceutical manufacturing
- Previous experience with technical documentation (investigations, SOPs, CAPAs, Risk Assessments) preferred.
- Quality systems, validation principles, regulatory guidelines, and multi-product controls
- Experience with distributed control systems (DCS) such as DeltaV and automated process equipment
- Consistent positive attitude and demonstrated ability to learn new skills
- Proficiency in routine operation of single-use equipment including but not limited to: mixing vessels, chromatography skids, TFF skids, filtration systems, etc preferred
- Strict adherence to established safety and compliance practices and standards
- Ability to think critically, with demonstrated troubleshooting and problem-solving skills as applicable to manufacturing process, documentation, and equipment. Takes initiative in solving issues.
- Self-motivated and willing to accept temporary responsibilities outside of initial job description and adjust workload based upon changing priorities
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
- Ability to lift 40 lbs repeatedly and stand for hours at time
- Able to work off-shift hours as well as weekends as needed
- Proficient in MS Office (Word, Excel, PowerPoint)
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/GileadAbout 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.
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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 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., Canada, Australia, Singapore, and Hong Kong 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.
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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.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.