Associate Director, Process Technologies and Development

Arbeitsbeschreibung

Associate Director, Process Technologies and Development

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.

Qualified candidates will be part of the process technologies and development group, acting as an interface between formulation scientists and manufacturing operations. The individual will lead the development of processes for both small molecule and large molecule (biologics) parenterals. We are seeking a creative, highly motivated, detail oriented individual to contribute in a cross-functional team setting. The candidate must demonstrate independent critical thinking, have scientific curiosity, be open minded and have an appetite for learning.

Specific Job Responsibilities

• Apply fundamental engineering principles to the design, development, scale-up, and validation of processes for sterile drug product unit operations (e.g., refrigerated/frozen storage and handling of bulk solutions, dissolution of APIs, pooling and mixing, sterile filtration, filling, pre-filled syringe processing, lyophilization, and vial capping) for both small molecule and large molecule parenterals

• Support extremely complex technical problems related to sterile processing engineering that advance Gilead portfolio priorities

• Execute studies and author reports related to container closure system compatibility and manufacturing process development

• Play a key role in the establishment of a state-of-the-art sterile process engineering lab

• Evaluate new/novel technologies relevant to parenteral drug product manufacturing

• Represent sterile processing engineering in cross-functional project teams

• Author regulatory filings (IND, NDA, BLA) to support global regulatory submissions

• Serve as a subject matter expert for development and commercial sterile processing operations

• Share expertise and provide guidance/mentorship to support the growth and development of talented junior team members

Knowledge & Skills:

• Excellent verbal, written, and interpersonal communication skills are required.

• Must be able to write clear, concise, and error-free documents.

• Expert knowledge of FDA and cGMP standards and sterile processing.

Required Education & Experience

• A Bachelor’s Degree in chemical engineering or a related scientific field and a minimum of ten (10) years of relevant industry experience

OR

• A Master’s Degree and a minimum of eight (8) years of relevant industry experience,

OR

• A Ph.D. Degree and a minimum of two (2) years of relevant industry experience.

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.