Job Description
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.
The New Products and Commercialization group within Organon Science and Technology has a position available for a Director for the development of packaging solutions to improve human health as a senior technical expert for new product packaging solutions. The candidate will:
Lead strategic initiatives for World Class Supply and Quality by Design for packaging development, including Packaging PQ right first time efforts, efforts to align packaging development to SKU harmonization, supply chain design functional work for packaging, and other efforts to improve the packaging development process.
The candidate will lead significant and complex packaging technical development projects as part of cross functional teams, integrated with packaging sites, supply chain organizations, and drug product development teams.
The position will lead the design and selection of container closure components used to deliver dosage forms to customers, to maintain the product integrity over the desired shelf-life while meeting customers’ use requirements.
Lead the design and selection of trays, cartons, shippers, security features, and thermal components to assure these new products are distributed throughout the supply chain robustly.
This position also includes development of primary, secondary and tertiary packaging solutions for upstream drug substance and key intermediates.
Fulfill these responsibilities through the design and execution of collaborative studies with formulation and analytical scientists, process development engineers, and packaging site operations engineers.
Have responsibility for new product packaging throughout the lifecycle of development, from clinical trials until commercial launch, including the preparation of relevant regulatory filing sections and responses that gain marketing approval of these new Organon products.
Lead and participate in cross functional teams in support of these efforts
Education Minimum:
Minimum of a Bachelor’s degree in mechanical engineering, chemical engineering, packaging science, biomedical engineering, or related disciplines.
Minimum of fifteen (15) years’ experience with B.S./M.S. or seven (7) years’ experience with Ph.D. in pharmaceutical development / engineering or medical device development
Required Experience and Skills:
Knowledge and understanding of dosage forms and delivery methods, including injection devices for self-administration, secondary packaging requirements, and cold chain distribution practices.
At least 7 years working on Integrated Development and Supply Teams (IDST) teams or new product development in drug product or packaging development.
Strong leadership skills including team facilitation across multiple functions
Ability to complete analysis of complex problems through critical analytical thinking and the design/execution of development plans for new products and new technology, including laboratory/pilot scale experiments
An enthusiasm for collaboration with a diverse set of business partners within research, development, and supply, at a variety of locations within and external to Organon.
Strong interpersonal collaboration and communication skills and the ability to manage projects and lead discussions with partners from other functional areas when conducting risk assessments, designing experimental test plans, and seeking to utilize materials and resources outside the control of New Product Commercialization.
Strong project and time management skills to allow for the ability to successfully track multiple project assignments at a variety of different stages of development.
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Employee Status:
RegularRelocation:
Domestic/InternationalVISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
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Hazardous Material(s):
Number of Openings:
1Requisition ID:R104914