Aseptic Process Engineer Jobs in Riverside, CA (NOW HIRING)

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. The Gilead Sciences La Verne Engineering Project Management Office (PMO) is seeking a Senior Manager, Tech Transfer Project Management. We seek a highly motivated and knowledgeable, individualto lead New Product Introduction (NPI) efforts for the La Verne site aseptic manufacturing of biologics or small molecule (fill/finish) and equipmentpurposed for the clinical flex fill line (Line 3) and commercial fill lines (Line 1 and Line 2), Labeling and Packaging lines.This individual will work directly with, and coordinate activities for, key stakeholders from multiple departments and cross different sites (e.g. Foster City) to ensure NPI projects, ranging from pre-pivotal to pivotal clinical phases, are executed to meet the global product technical transfer timeline, clinical demands, and commercialization to meet internal customer expectations.

This position is onsite daily in La Verne, CA, relocation is not offered therefore local candidates are encouraged to apply.

Key Responsibilities:

Program Management:

• Lead and manage multiple, concurrent clinical and commercial NPI projects impacting the fill/finish or inspection, labeling and packaging areas and equipment.

• Define and understand product transfer scope, timelines, and demands from PNGC or PPSC endorsement through manufacturing and release, coordinating resources from the La Verne site to meet objectives.

Quality and Compliance Oversight:

• Ensure product transfer team can deliver products to meet compliance with regulatory requirements, Current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), Safety regulations, and other relevant standards.

• Facilitate necessary gap assessment with the SMEs from La Verne or from the global sites.

Work Plan Development:

• Develop comprehensive work plans for each product transfer in collaboration with cross-functional teams, including Technical Services, Packaging, Quality Assurance (QA), Quality Control (QC), Validation, Supply Chain, Regulatory/CMC, EHS, Finance, IT, and Engineering.

Project Team Management:

• Oversee and manage daily workflow of the project team, ensuring that milestones are met and any potential risks or delays are proactively addressed.

• Milestones can be ranging from machine line trials, installation/debug/startup, Acceptance Testing and Commissioning (ATC), and PPQs (commercialization ready), and product runs/studies for any follow-up measures per the regulatory feedback/demands.

Task Tracking and Escalation:

• Track the status and completion of critical tasks, such as procurement, documentation, and studies, to ensure milestones are achieved. Escalate issues when necessary to ensure timely resolution.

Cross-Functional Guidance:

• Utilize knowledge in filling and packaging processes and equipment to provide guidance and support for global, cross-functional discussions, ensuring alignment of decisions to meet project objectives.

Stakeholder Representation:

• Represent the La Verne cross-functional team in NPI-focused meetings with corporate stakeholders, facilitating communication and bridging any gaps in understanding between corporate and site personnel.

Project Review and Leadership:

• Lead regular project review meetings with cross-functional representatives, ensuring projects are on track and addressing any deviations promptly.

Senior Management Reporting:

• Provide regular and timely updates to senior management on the status of NPI projects, including upcoming, ongoing, and completed initiatives. Collaborate with senior leadership for key decision-making.

Problem-Solving and Innovation:

• Tackle moderately complex problems by applying creative problem-solving techniques and offering innovative recommendations to drive project success.

Decision-Making and Judgment:

• Exercise sound judgment in selecting appropriate methods, techniques, and evaluation criteria to achieve project goals while adhering to defined practices and policies.

Tactical Leadership:

• Provide tactical guidance and management to the project team, ensuring alignment with broader Operations objectives and strategies.

Procedure and Process Improvement:

• Contribute to the development and implementation of standardized procedures and processes to ensure consistency in Project Management. Play a key role in the creation of new concepts, techniques, and operational standards.

Basic Qualifications:

Bachelor's Degree and Eight Years' Experience

OR

Masters' Degree and Six Years' Experience

OR

Ph.D.

Preferred Qualifications:

• 10+ years of relevant experience in pharmaceutical industry with a focus on small molecule or biologics fill/finish, inspection, labeling and packaging and a sciences BS/BA degree.

• 6+ years of relevant experience in pharmaceutical industry with a focus on small molecule or biologics fill/finish, inspection, packaging and a MS, MA or MBA.

• 5+ years successfully serving as a project manager.

• Proven experience in managing complex NPI or technology transfer projects.

• Knowledge of cGMPs, GLPs, and regulatory requirements in a manufacturing setting.

• Demonstrated leadership ability in cross-functional teams, including Technical Services, MSAT, Manufacturing/Packaging, QA, QC, Validation, Supply Chain, and Engineering.

• Excellent communication skills, with experience interfacing with senior management and cross-functional global teams.

• Strong problem-solving and decision-making skills, with a focus on driving project success in a fast-paced environment.

• Proficient in Microsoft Office applications.

People Leader Accountabilities

Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.

Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

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.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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.comfor assistance.

For more information about equal employment opportunity protections, please view the'Know Your Rights' poster.

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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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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Please apply via the Internal Career Opportunities portal in Workday.