Organon - Associate Director, Pharmaceutical Commercialization Technology ( MERCUSR103340ENUS)
This position is for Associate Director (P4) of Pharmaceutical Commercialization Technology (PCT) in the New Products organization. PCT is responsible for pharmaceutical process development of oral solid dosage forms and sterile/liquid large molecule drug products from Phase IIb through regulatory filings, process performance qualification, and into the first years of commercial launch. This work will primarily be executed via external partners/CDMOs with oversight from PCT.
The Associate Director is a key technical leader and directs process development activities associated with a portion of the late stage pharmaceutical project portfolio. This role oversees the efforts for creating and executing process development plans, aligning with the clinical supply strategy, developing and documenting the knowledge base needed for regulatory filings, and managing the project through early launch and supply. The Associate Director ensures that relationships with relevant partner groups - upstream, downstream, and parallel - are managed collaboratively, efficiently, and effectively.
The Associate Director will lead high impact, complex, cross-functional divisional teams and initiatives.
Creates, maintains, and supports processes for sharing and making decisions vertically and horizontally for development candidate projects and technology
Development plans and outcomes for Final Market Formulations and commercial processes across the portfolio
Escalates issues appropriately for visibility and resolution within Tier structure
Anticipates and adjusts or redefines goals and plans across teams in response to changes in business needs
Build Capability and Strategic Thinking
Influences departmental strategy and tactics.
Makes informed cost/ benefit decisions based on analysis of inputs, risk and likely return, and takes ownership of the outcomes.
Leverages communication mechanisms and business processes for technical and business topics to facilitate decision making and leverage the collective experience of the organization.
Influences interactions with key partner groups, and helps to set strategy and tactics across functions.
Directs departmental and cross-functional strategic initiatives and demonstrates the necessary collaboration skills to integrate input and perspective from various sources, and demonstrates ability to explain the decision and its implications to key stakeholders.
Mentors and coaches staff within the organization. Uses feedback to improve self and others, and to ensure that customer/stakeholder needs are the cornerstone of decisions, expectations are met on a consistent basis, and works with a long-term perspective in addressing customer problems.
Participates in performance management
Technical Expertise | Contribution | Development
Has fluency of scientific/technical concepts and techniques, applies and furthers those concepts and techniques in pursuit of resolving scientific/technical issues
Ensures technical capability build and maintenance of expertise within organization
Wide depth and breadth in all aspects of solid dosage form or sterile/liquid large molecule drug product process development, including standard and enabled formulations and processes, characterization techniques, and experimental data analysis and modeling, including statistical and first-principle approaches
Leads application of Quality by Design (QbD) development in regulatory filings, with an emphasis on process robustness and flexibility with business benefits using enhanced and traditional control strategies
Education and Experience Minimum Requirements
Bachelor of Science in Chemical Engineering, Pharmaceutical Sciences or a related field with a minimum of eight years industrial experience, including development of solid dosage forms or sterile/liquid large molecule drug product
Master of Science in Chemical Engineering, Pharmaceutical Sciences or a related field with a minimum of six years industrial experience, including development of solid dosage forms or sterile/liquid large molecule drug product
Ph.D in Chemical Engineering, Pharmaceutical Sciences or a related field with a minimum of four years industrial experience, including development of solid dosage forms or sterile/liquid large molecule drug product
Residents of Colorado
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Who we are … Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion. At Organon, we all belong. We embrace diversity and give it a voice. Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.
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