Sr Manager, Product Development & Technology

Location
Lake Forest, IL, United States
Posted
Oct 30, 2020
Ref
R0002133
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 Director, Product Development & Technology (PD&T), the Senior Manager, PD&T is primarily responsible for providing technical expertise and leadership for the evaluation, development and LCM activities of medical devices and combination products. Secondary responsibilities may include providing technical expertise for the scale-up, transfer and optimization of development processes from clinical development through product launch stages. In addition, the Senior Manager PD&T may be responsible for the standardization and improvement of existing processes as part of life cycle management, corrective and preventative actions, deviation, complaint and failure investigations. The Senior Manager, PD&T will lead efforts in the Feasibility, Design Input, Design Output, Design Verification, Design Validation and Design transfer Design Control phases, internally or via identified contract development and manufacturing organizations (CDMOs) as needed. She/he 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. She/he will also ensure that development and/or modified products are robust, compliant, efficient and can be validated commercial medical products meeting regulatory requirements.

Responsibilities:
  • Provide technical ownership and project leadership to cross-functional teams for medical device and combination product projects from technology evaluation through clinical development, product registration, launch readiness and LCM
  • Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers that meet business needs
  • Establish and maintain medical device and combination product device constituent elements of the DHF and associated project plans
  • Identify and document technical risks and assumptions in plans and recommend / implement contingency plans
  • Development of drug-device and biologic-device combination products or companion diagnostic devices appropriate for use in clinical trials and ultimately commercially
  • Project leader on cross-functional Technical Operations development objectives, including platform solutions; identification, product/process development and deployment of solutions to address development objectives
  • Technology transfers, scale-ups, engineering/feasibility studies, process validations, test method development, and cleaning validations
  • Document generation, review, and approvals in support of regulatory submissions, including engineering & validation protocols, risk analysis, development reports, in process data, stability reports, investigations, deviations, specifications, requirements trace matrices, change controls, and other documents as required; Working in conjunction with QA as appropriate
  • 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
  • Lead the strategies, planning, management and execution to the completion of technology transfer in accordance with timelines, budgets and company objectives; contributes to budget establishment and manages expenses in accordance with approved budget


Qualifications and Skills Required:
  • BS in Biomedical / Mechanical / Chemical Engineering, Biotechnology or related field
  • 7+ years industry experience in medical device, combination product, and/or pharmaceutical manufacturing technical operations with at least 3 years in leadership/project management roles. Experience with reconstitution, infusion, injection, or companion diagnostic products strongly preferred
  • Must have prior experience working, negotiating, or managing external CDMO, CMO and/or consultants
  • Understanding and experience with FDA Design Controls, Design History Files (DHFs), Combination Products, cGMP drug development spanning bench top to commercial production inclusive of DOE, technology transfers, manufacturing, equipment qualification, process & cleaning validation, and regulatory submissions (IND/NDA/BLA/MAA)
  • Thorough understanding of good manufacturing/laboratory practices (GMP/GLP) 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.