Senior Manager, Process Development
Location: Rockville - Remote - Rockville, United States
Date Posted: Jul 15, 2024
Requisition ID: AR1475
Job Type: Full-time
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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.
Position: Senior Manager, Process Development
Department: CMC
Location: Remote
Overview
The Senior Manager, Process Development will provide technical 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 disciplines, leveraging past experiences.
As the technical lead of the function, this position represents a single point of CMC accountability for advancing biologics with Aurinia’s pipeline. As a technical leader, it is expected that the Senior Manager 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.
Primary Responsibilities
- Work with the CMC Leader and develop 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, 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 with emphasis to drug product formulation development.
- 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.
- Guides the design and execution of development studies to evaluate drug product 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.
- 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.
Qualifications
- BS/MS plus 5+ years of experience in the pharmaceutical and/or biotechnology industry with demonstrated experience in biologics process development, preferably in downstream process
- PhD preferred but not required
- 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 working with and managing the relationship with 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
- 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 team
- Ability to travel to CDMO sites as needed.
Additional Information
All candidate information will be kept confidential according to EEO guidelines.
All candidate information will be kept confidential according to EEO guidelines.
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