Description

Pharmaceutical Development & Manufacturing (PDM) Rotational Development Program
United States - California - Foster City

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. Gileads 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 companys five core values. Thats 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 #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.


Job Description


Pharmaceutical Development & Manufacturing (PDM) Rotational Development Program

With an eye for increasing diversity in our workforce, Gilead employees are headed to the classroom to help teach and train the next generation of professionals. Members of the Gilead Pharmaceutical Development & Manufacturing (PDM) organization have spent more than a year developing an advanced and first of its kind undergraduate course designed to introduce students to a career in pharma and to offer opportunities to apply lessons learned in the classroom to job rotations at Gilead.

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Required Qualifications:

• Bachelor's or Master's degree
• Completed Pharmaceutical Development Coursework (preferred)
• Relevant laboratory experience for lab-based role
• GPA> 2.8
• Authorized to work in the United States without Sponsorship
• Must be a Senior in undergrad or a Graduate or Doctoral Student
• Must show proof of full COVID-19 vaccination*

Preferred Qualifications:

• Proficiency with MS Office Suite
• Ability to identify issues and seek solutions
• Ability to work both independently and collaboratively
• Demonstrated commitment to inclusion and diversity in the workplace
• Efficient, organized, and able to handle short timelines in a fast-paced environment

Gilead Core Values:

• Integrity (Doing What's Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)

As an equal opportunity employer, Gilead Sciences has a strong commitment to diversity and inclusion. 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 careers@gilead.com for assistance. For more information about equal employment opportunity protections, please view the EEO is the Law poster.

We are an equal opportunity employer. Apply online today at www.gilead.com/careers.

Location & Department Details

Location: Foster City, California

Drug Substance Materials Sciences & Process Safety and Engineering

The mission of this group is to identify and to design the best materials and solid-state processing techniques and technology that can enable robust drug substance properties for the life cycle of all Gilead compounds. Our commitment is to utilize effective technologies and predictive tools in material selection and performance evaluation, and to develop material options through innovative process design and optimization to support these efforts. There are three main areas of focus: 1) Solid-state chemistry and materials characterization; 2) Application and development of analytical tools, process analytical technology (PAT), and chemometrics for process understanding, safety evaluation, and process development; and 3) Chemical process engineering to support process robustness and scale-up performance optimization. In this role various analytical techniques are utilized including thermal and bulk properties characterization methods. Scientists in this role design and execute experiments, applying knowledge from organic and analytical chemistry and/or chemical engineering courses. Scientists from this team collaborate closely with colleagues from Drug Substance Process Chemistry team, Formulation and Product Development, and Analytical Chemistry team to inform and select the appropriate drug substance form for product development. This is predominantly lab-based work focused on drug substance testing, characterization, and documentation.

Drug Substance Process Chemistry Development

Process Chemistry Department is responsible for the design and development of chemical processes for the synthesis and manufacturing of drug substances. Scientists in this group work in teams to perform chemical reactions, workups, and crystallizations for the conversion of reactants to products in a synthetic route. Chemical processes are developed to optimize the yield and purity of products, chemical safety, greenness and environmental sustainability, and overall robustness and efficiency. Scientists use analytical tools to evaluate the performance of their reactions and the quality of their isolated products. Processes developed in the laboratory may be scaled in kilo lab or pilot plant for the manufacturing of compounds to support the delivery of drug substances for animal studies and clinical trials. This is predominantly a lab-based function focused on drug substance process development, scaleup, technology transfer, and documentation.

Product Development - Formulation and Process Development

The mission of the Product Development team is to develop a product that is appropriate for the targeted patient population that is convenient and can be reproducibly manufactured to consistently deliver the desired dosage strength, and the intended performance of the product. The Product Development team consists of two key functions, the formulation and process development team and the Device Development and Clinical Packaging Engineering team, which work collaboratively to design and develop the final product configuration.

The Formulation and Process Development team supports activities related to product development and includes preclinical- and/or clinical-stage projects. This team is responsible for design and execution of preformulation and formulation development of small molecule drug products, irrespective of route of delivery (oral, injectable, inhalation, topical, etc.). Individuals within this team design and execute experiments to determine chemical and physical stability of the active ingredient (pre-formulation), identify an appropriate formulation composition, develop the manufacturing process to produce the formulation (formulation and manufacturing process), and address scaleup considerations. The role utilizes practical application of knowledge gained from organic and analytical chemistry, pharmaceutical chemistry, chemical engineering, and packaging engineering. This team interacts closely with the DDCPE team to determine the best container closure and packaging components. This is predominantly a lab-based function focused on drug substance preformulation, formulation design, product manufacturing process, scaleup, technology transfer, and documentation.

Product Development - Device Development and Clinical Packaging Engineering (DDCPE)

The mission of the Product Development team is to develop a product that is appropriate for the targeted patient population that is convenient and can be reproducibly manufactured to consistently deliver the desired dosage strength, and the intended performance of the product. The Product Development team consists of two key functions, the formulation and process development team and the Device Development and Clinical Packaging Engineering team, which work collaboratively to design and develop the final product configuration.

The Device Development and Clinical Packaging Engineering group is responsible for (1) development of drug delivery devices, (2) evaluation of parenteral container closure systems, and (3) development of primary, secondary, and tertiary pharmaceutical packaging. Activities include authoring and execution of test protocols and reports, design and manufacture of fixtures that support testing, authoring of specifications, support for human factors studies, partnering with suppliers and contract manufacturers, and collaboration with internal Gilead stakeholders. The role is a mixture of office and lab-based work focused on device, parenteral container closure system, and package development, testing, and documentation.

Analytical Operations (AO)

Analytical chemistry is the science of characterizing and communicating information about the composition and structure of matter. Analytical chemists in this role use their knowledge of science, instrumentation, and statistics to provide information on drug substance and drug product development that ensures drug product quality, performance, and safety. Through the lens of AO, analytical chemist supports clinical and commercial activities by collaborating across functional areas such as Formulation Development, Process Chemistry, Quality Assurance and Regulatory Sciences. This is predominantly a lab-based work focused on applying analytical skills to method developments, pharmaceutical compound characterization, and documentation.

Quality Assurance

This team is responsible for quality operations, quality systems and cGMP regulations to ensure compliance of clinical and commercial products. Candidate(s) will have the opportunity to put the knowledge acquired from chemistry, statistics, engineering, math and biology classes into practice to help provide QA oversight in the development and commercialization of pharmaceutical products. This team supports clinical and commercial stage activities and collaborates across Gilead (internal) functional areas (ex. Formulation Development, Process Chemistry, Analytical Operations, Supply Chain, Commercial Manufacturing, Packaging Engineering Regulatory Sciences), and partners (external). Candidates may interact with multiple QA functional units such as Supplier Oversight, Audits & Inspections, Quality Engineering, Quality Systems, QA Operations, Document Control and QA Program Management. This is predominantly an office function focused on documentation and supporting GMP plant operations.

Regulatory Affairs Chemistry and Manufacturing Controls (RA CMC)

Prepares and maintains regulatory submissions for investigational and commercial products for all modalities including small molecules, biologics, and devices, and including manufacturing site registrations. RA CMC team prepares the Chemical Manufacturing and Controls (CMC) sections of the Investigational New Drug (IND), New Drug Application (NDA), or Biologics License Application (BLA) for the US and all other global markets. RA CMC team interacts with Drug Substance, Drug Product and Analytical Regulatory Strategy teams to align on the regulatory filing strategy and to compile and include necessary information for the regulatory submissions. The RA CMC team maintains the registered details for all global licenses in Gilead's Product Information Docket system (GPID) to ensure conformance of lots released. The team also manages regulatory updates to Annual Reports, Development Safety Update Report (DSURs), Annual Product Quality Review (APQRs), and product/GMP license renewals via collaboration across functional areas such as Formulation Development, Process Chemistry, Analytical Science, and Quality Assurance. This is predominantly an office-based work focused on documentation and document submissions.

Global Supply Chain

Global Supply Chain manages the supply chain from clinical development to commercial production working cross-functionally with Technical Functions, Quality, Development and Commercial. Roles in this group include clinical and commercial supply planning, logistics and distribution, supply chain strategy, CXO network management including clinical and commercial site selection and supplier management, commercial launch readiness and optimization of business processes. Candidates can expect to gain valuable experience in supply planning, supplier management, external contracting and partnerships and drug manufacturing processes. This is predominantly an office-based function focused on documentation and document submissions.

Project Management

Chemistry, Manufacturing, and Controls (CMC) Project Manager supports the CMC programs by overseeing the drug development process throughout its lifecycle (research, development and commercial). Responsibilities may include managing cross-functional development or commercial teams, CMC related initiatives, and/or managing the business relationships of our contract manufacturing/testing sites. Project Managers are expected to work cross-functionally to set detailed timelines, track major deliverables, identify barriers and find ways to remove them, facilitate team meetings, set meeting agendas, capture meeting minutes, create reports, and draft presentation slides. Project Managers are expected to partner with the Project Leader to lead the collaborations to create and maintain a dynamic team environment that enables innovations.

The salary range for this position is: $83,895.00 - $108,570.00. 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:

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 careers@gilead.com 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.

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

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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 log onto your Internal Career Site to apply for this job.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Pharmaceutical-Development---Manufacturing--PDM--Rotational-Development-Program_R0035501







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