Sr Manager, Product Development & Technology

Location
Lake Forest, IL, United States
Posted
Oct 25, 2020
Ref
R0002132
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
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.

Position Summary:

Reporting to the Sr. Director, Product Development & Technology (PD&T), the Senior Manager, PD&T is responsible for providing technical expertise for the development, scale-up, transfer and optimization of drug product processes from clinical development through product launch stages. In addition, the Senior Manager PD&T will be responsible for the improvement of commercial processes, in conjunction with the Commercial Manufacturing group, as part of life cycle management activities including efforts to address corrective and preventative actions and deviation and complaint investigations. The Senior Manager, PD&T will lead efforts in the technology development, technology transfer, process validation and cGMP manufacturing of clinical supplies via identified contract development and manufacturing organizations (CDMOs). The Senior Manager, PD&T will engage with cross-functional departments, equipment manufacturers, material suppliers, contract development and manufacturing organizations to ensure that the technical needs of development and manufacturing operations are realized on a consistent basis. The Senior Manager, PD&T will ensure that development processes are robust, compliant, efficient and can be validated commercially.

Responsibilities:
  • Lead CMC developmental programs, manufacturing scale-up, validation, and technical transfers of the Horizon small molecule product portfolio.
  • Head the identification and evaluation of service providers (CDMO) to efficiently execute against Horizon objectives.
  • Project leader on cross-functional Technical Operations development objectives, including platform solutions; identification, process development and deployment of solutions to address development objectives.
  • Identify CQAs and develop and execute strategy to determine CPPs, KPPs, and non-critical process parameters for applicable manufacturing processes utilizing tools such as DOE and ANOVA.
  • Oversee and perform data collection, analysis, and trending of pharmaceutical unit operations including but not limited to: formulation, tableting, encapsulation, coating, packaging, and other operations for finished drug product & drug substance.
  • Drive completion of engineering/feasibility studies, process validations, and cleaning validations
  • Document generation, review, and approvals including engineering & validation protocols, master batch records, executed batch records, development reports, in process data, stability reports, investigations, deviations, specifications, change controls, and other documents as required
  • Participate in investigations for mechanical, process, and human failures in manufacturing/packaging and assess resulting impact to product/program; collaboratively resolve root causes of anomalies
  • Contribute to budget establishment and management of expenses in accordance with approved budget
  • Contribute CMC strategy and prepare technical content for regulatory submissions including INDs, IMPDs, NDAs, and other relevant regulatory submissions; represent company as product expert before U.S., European, and other global regulatory authorities


Qualifications and Skills Required:
  • BS in Chemistry, Chemical Engineering, Biotechnology or related field
  • 7+ years industry experience in pharmaceutical manufacturing technical operations with at least 3 years in leadership/project management roles. Experience with development and production of multiple dosage forms preferred (solid/oral tablet, topical, sterile injectable)
  • Must have prior experience working, negotiating, or managing external CDMO, CMO and/or consultants
  • Understanding and experience with drug development spanning bench top to commercial cGMP production inclusive of DOE, technology transfers, equipment qualification, process & cleaning validation, and regulatory submissions (IND/NDA/ MAA)
  • Thorough understanding of current Good Manufacturing Practices (cGMP) and regulatory compliance/documentation requirements
  • Exceptional organizational skills in handling multiple priorities/projects, and demonstrated ability to meeting required forecasts, budget objectives, and milestones
  • Proven record for leading successful implementation and optimization/continuous improvement efforts in a forward-thinking development environment
  • Excellent oral/written communication skills
  • Excellent leadership, managerial and communications skills in cross-functional environments
  • Ability to travel domestically and internationally

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.