Manager, Product Development & Technology
Company: Horizon Therapeutics
Location: Buffalo Grove
Posted on: May 12, 2022
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Job Description:
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 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 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 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. The
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 Manager, PD&T 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 including engineering & validation protocols,
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. Experience with infusion or injection combination
products (pre-filled syringes, autoinjectors, and on-body
injectors), 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 and global 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 requires all U.S. employees to be fully vaccinated, as a
condition of employment, with either Pfizer (fully approved by the
U.S. Food and Drug Administration), Moderna or Johnson & Johnson
(currently granted emergency-use authorization by the FDA). "Fully
vaccinated" is defined as two weeks after your final dose of the
Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide
medical and religious accommodations as required by law.
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.
Keywords: Horizon Therapeutics, Buffalo Grove , Manager, Product Development & Technology, Executive , Buffalo Grove, Illinois
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