Principal/Sr Principal Scientist, Process Development

Rockville, MD, United States

Description

Our Mission: Changing the trajectory of autoimmune diseases.

Our Vision: Enabling patients to live their fullest life.

We are a dedicated team of experts committed to changing the trajectory of autoimmune diseases with unmet medical needs. We are relentless in our pursuit to provide transformative medical treatments. We are resilient. We Care.

Along with driving adoption of our approved therapy, LUPKYNIS, for appropriate people with lupus nephritis, we are pursuing a broader portfolio of innovative autoimmune disease therapies.

We provide high quality products to our patients, that are safe and effective. Each of us at Aurinia own Quality, and we proactively integrate Quality into everything that we do. Exceptional quality and regulatory compliance are essential to our business, and "We Care" so that patients can take our drugs with confidence.

Our strategy leverages the skills and knowledge of our expert team and our deep experience in principled drug development and commercialization. Aurinia's working environment enables every individual to thrive in a professional atmosphere guided by our Culture Values:

Achieve together

Collaborate

Explore & build

Act responsibly

Together, we drive to change the trajectory of autoimmune disease for patients in need.

Overview

The Principal, Process Development will provide both technical and strategic leadership for process development, scale-up and manufacturing activities, with specific focus on biologics. This role requires experience working in a fast-paced, high-growth environment and the ability to lead across functions and discplines, leveraging past leadership experiences.

As the leader of the function, this position represents a single point of CMC accountability for advancing biologics with Aurinia's pipeline. As a leader, it is expected that the Principal will be a part of highly collaborative cross-functional teams to advance protein therapeutic candidates from early development to commercialization and serve as the technical subject matter expert for the project team.

Responsibilities:

Sets the vision and direction and develops strategic plans for CMC process development for biologics at Aurinia.

Oversees development, implementation and maintenance of process methods and equipment for the production of process formulas, technologies, and products to ensure cost effectiveness and improved product quality.

Collaborates with internal and external teams to oversee and support biologic drug substance and drug product development and manufacturing activities.

Applies a fundamental understanding of mammalian cell culture operations to support upstream bioprocess development activities including technology development, yield and process optimization, and process characterization studies.

Leads the development, characterization, and optimization of drug substance manufacturing unit operations, such as cell culture fluid clarification, in-process holds, viral inactivation, and chromatographic purification.

Guides the design and execution of development studies to evaluate formulations and primary drug container closure systems, as well as in-use subcutaneous and intravenous (IV) delivery systems and conditions.

Conducts the development, characterization, and optimization of drug product manufacturing unit operations, such as bulk storage freezing/thawing, compounding/mixing, sterile filtration, vial or syringe filling, and lyophilization.

Collaborates with internal and external teams to support drug substance and drug product development and manufacturing activities.

Addresses the analysis and evaluation of process development procedures and practices to ensure compliance with regulatory, legal and good manufacturing procedures to attain corporate goals.

Works closely with CDMOs to identify potential risks and help formulate mitigation strategies to ensure regulatory success.

Responsible for the preparation of CMC contents for regulatory submissions and correspondences, in collaboration with CMC and Regulatory functional leads.

Works with the business development team in assessment of CMC packages of external biologic programs.

Ensures the organization is adequately staffed with the right team to build and brings on talent when needed.

Requirements:

PhD. plus 15+ years of experience in the pharmaceutical and/or biotechnology industry with 8+ years demonstrated leadership in biologics process development, preferably within a high growth environment.

Experience in drug substance and drug product process development, manufacture of clinical supplies, development of efficient and scalable manufacturing processes, and regulatory CMC (INDs, IMPDs, BLAs).

Working knowledge of the broad range of biologic CMC disciplines (upstream & downstream process development, purification, formulation & delivery technologies).

Experienced in managing CDMOs.

Working knowledge of cGMP and relevant regulatory guidance (i.e. ICH, FDA, and EMA).

Experience developing, implementing and executing strategic plans and objectives; ability to create strategies that show a clear connection between vision and action.

Experience participating in the development of corporate methods, techniques and evaluation criteria for projects, programs, and people.

Hands-on, roll-up-your-sleeves approach, with high sense of urgency and drive for results

Demonstrated communication, problem-solving, and negotiation/decision-making skills; an executive presence.

Ability to think outside of the box and challenge the status quo.

Desire to work in a fast-paced, innovative environment and develop a high-performance team.

Ability to comfortably manage the uncertainty of change.

A natural collaborator who enjoys working on cross-functional teams; is an influencer and leader.

Ability to consistently exhibit Aurinia's values at a high level.

Additional Information

All candidate information will be kept confidential according to EEO guidelines.

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