Associate Director, Technical Development – Biologics

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

The Position:

Reporting to the Vice President, Biologics and Development, the successful candidate will bring scientific and technical knowledge to the organization.

This position will be a key player in the tech transfer and subsequent implementation of a cell culture process producing the companies most critical flag-ship product. A key participant in risk assessments and gap analyses associated with the transfer as well as execution of development studies, development of validation packages and subsequent execution of feasibility, engineering and validation batches.

This position will support an ongoing validation at another West Coast site, PAI and subsequent transition to commercial manufacturing. This role involves close interaction with CMOs and CROs including person-in-plant.

Responsibilities:

The role will involve significant interaction with other Technology Operations team members including quality assurance (QA), manufacturing, supply chain and project management to support tech transfer and process implementation at the receiving site. You will also interact closely with the CMC regulatory team for submission of regulatory documentation and commitments.

This role will require an ability to manage a substantial tech transfer program with a large emphasis on communication of progress, identification and resolution of issues and management of timelines. It also requires a technical excellence in both upstream and downstream processing with a key emphasis on quality. This role will evolve into a manufacturing support role for the manufacturing of DS at our CMO's two US sites.

Primary responsibilities include:

• Provide engineering and technology support for development activities, technology transfer and commercial production of Drug Substance.
• Ensure assigned technology transfer and development project activities are completed in a timely manner.
• Communicate status of project, identify risks and propose solutions. Bring teams together and work collaboratively with quality and supply chain stakeholders.
• In collaboration with contractors, collect and trend process, analytical and stability data and ensure discrepancies are investigated.
• Support external Product/Process Development and Manufacturing functions to ensure a smooth transfer of technologies and products between sites.
• Collaborate with contract manufacturers during development, production and testing of product.This may include scheduling and running teleconferences, generation and distribution of meeting minutes to project team. If necessary, debottleneck and rationalize processes to optimize processes consistency, yield, and robustness
• Assist in preparation of documentation to support BLA, CBE and PAS submissions and fulfilment of post marketing commitments.
• Support a culture of collaboration, participation and knowledge development among the team.
• Bring scientific and technical expertise to the organization as well as remaining current with latest technologies.

Qualifications and Skills Required:

Working with bioreactors/fermenters and downstream technologies in a manufacturing setting is necessary for this position. Experience scaling up upstream and downstream processes and an understanding of the critical elements associated is also key.

The successful candidate will have completed tech transfers, have familiarity with gap analyses and risk assessments. An understanding of IQ, OQ, facility as well as cleaning and process validation is also important.

A deep understanding of biological processes that includes critical and key process parameters, process and product based impurity generation and removal in support of scale-up and technology transfers is required.

A working knowledge of process development and/or manufacture of biological products using microbial and/or mammalian expression systems that includes hand-on experience with fermenters (lab-scale and/or manufacturing scale) as well as familiarity with analytical techniques is necessary. The successful candidate will also have a working knowledge of downstream technologies and understanding of chromatography dynamics and purification principles.

• Be able to demonstrate expertise in technology transfer and/or scale-up/down of processes.
• Have a familiarity with quality systems and both FDA and EU regulations as they relate to process / product development and manufacture of biologics.
• Knowledge of process characterization activities and Quality by Design (QbD) principles.
• A demonstrated track record of delivering timely and consistent results and familiarity with project management skills for technical programs.
• Bachelor's degree in engineering or an applied science is required.An advanced degree is preferred.
• Over five years of relevant pharmaceutical development and manufacturing experience in Biologics.
• Travel is an important feature of this role. It will be required for the candidate to be flexible to locate at our CMO site in Colorado periodically for example, when a manufacturing campaign is underway.

Horizon Core Values & Competencies:

Growth

• Manages Ambiguity
• Strategic Mindset
• Demonstrates Self-awareness
• Cultivates Innovation
• Develops Talent

Accountability

• Drives Results
• Ensures Accountability
• Decision Quality

Transparency

• Courage
• Collaboration
• Instills Trust

Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.