Manager, Biologics Pilot Lab Operations - Pre-Pivotal Biologics
Gilead Sciences, Inc.
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**
The Manager, Biologics Pilot Lab Operations, will be responsible for coordinating biologics pilot lab operations including GLP drug substance manufacturing, pilot lab facility and equipment readiness, manufacturing operation scheduling, planning, preparation and execution as well as supporting process scaleup. He/she will support process transfer and timely delivery of protein therapeutics to support toxicology studies and Research activities. This role will develop, coordinate and execute plans to improve pilot lab operation capability, capacity and efficiency.
**Key Responsibilities:**
+ Maintain a state-of-the-art biologics pilot lab for manufacturing process scale up and timely delivery of therapeutic proteins to support process development, toxicology studies and Research activities.
+ Coordinate, plan, execute and document therapeutic protein material generation runs. May lead projects in the biologics pilot lab.
+ Ensure pilot lab facility and equipment readiness in collaboration with site supporting functions. Procure and maintain chemical and consumable inventories.
+ Support process transfer into pilot lab and atypical process event trouble shooting in collaboration with key stakeholder functions including Cell Line Development, Cell Culture, Purification and Formulation Development.
+ Author and maintain GLP- and non-GMP technical documentation such as batch records, work instructions, guidance documents and reports.
+ Train and mentor pilot lab operation team members on authoring GLP documents, pilot scale cell culture and purification operations. Ensure safe pilot lab operations.
+ Plan and execute technology innovation and improvement projects as well as optimizing pilot lab operation efficiency.
+ Adhere to department budget and all training, compliance, and safety requirements.
**Basic Qualifications:**
Bachelor’s Degree with 6 years’ experience
OR
Master’s Degree with 4 years’ experience
OR
PhD/ PharmD
**Preferred Qualifications:**
+ Associate degree with 10+ or BA/BS with 6+ of relevant experience in biologics pilot plant/manufacturing operations.
+ Experience in biologics manufacturing equipment operations and single-use manufacturing technologies. Working knowledge in equipment automation and data management is a plus.
+ Hands-on experience in pilot scale media and buffer preparation, cell culture and/or purification unit operations.
+ Proven track records in pilot lab facility maintenance, raw material and consumable procurement and inventory management, equipment maintenance and troubleshooting. Experience in process transfer is a plus.
+ Experience in authoring and maintaining GLP batch records, BOMs, work instructions, guidance documents, production reports and pilot lab training program.
+ Excellent organization skills. Demonstrated ability to plan and coordinate pilot lab operation activities. Experience in mentoring and coaching junior staff is a plus.
+ Demonstrated experience in pilot lab operation efficiency optimization.
+ Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.
+ Demonstrated ability to collaborate and influence cross-functionally.
+ Passion for inclusion: knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he/she works.
**People Leader Accountabilities:**
+ Create Inclusion - knowing the business value of diverse teams, modelling 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, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $136,340.00 - $176,440.00. 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.
**For jobs in the United States:**
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.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
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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.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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