Associate Director, Drug Product Development

Associate Director, Drug Product Development

Overview:
The Associate Director of Product Development will oversee Civica’s pharmaceutical product development for the various dosage forms in Civica portfolio. This role will be a hands-on technical leadership on a cross-functional project team for drug development from the early phase, scale down batch process, through scale-up including technology transfer activity support to commercialization. The responsibilities include the establishment of a development plan with strategic CMC and providing technical direction for successful product development.

The position will plan, execute drug product development, and collaboratively perform CMC strategies across internal disciplines and external partners, including contractors. Additionally, the position will manage the preparation of the Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA) and Biologic License Applications (BLA) to support regulatory filings. This candidate will guide the formulation, process development, verification, and validation of pharmaceutical products in support of Civica’s R&D portfolio of sterile injectables, oral solid dosages, and drug delivery devices as necessary.

• Lead the design and execution of drug product formulation and process development, characterization and robustness studies.
• Lead scale-up and technology transfer activities of products for internal and external manufacturing sites.
• Translate product development project requirements into a robust, scalable technical design.
• Resolve complex problems by applying sound engineering and product development principles, including Quality by Design (QbD) and Design of Experiments (DoE), utilizing experimental, and analytical methods to support technical product development challenges over a range of products from simple sterile injectable vial products, oral solid dosage forms to more complex pre-filled syringe – disposable auto-pen injector combination products.
• Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management.
• Understand the scientific principles for manufacturing parenteral drug products, device assembly and packaging, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
• Deliver Technology Transfer Plan through product life cycle of technology transfer, engineering, clinical, PPQ, and process validation, and control strategy development.
• Participate in and lead the development and implementation of product FMEA, risk assessments, investigations, process development and implementation, Master Batch Record preparation, filtration and filling assemblies, root cause analysis for investigations and troubleshooting.
• Support product regulatory complete response letters, preapproval inspections, and other audits from outside agencies. The role interacts with regulatory agencies during site inspections.
• Understand and implement manufacturing control strategy for various product unit operation areas.
• Review and approve cGMP documents such as New Product Introductions to site, Product Development Reports, engineering protocols, batch records, technical reports, change controls, validation protocols, and summary reports.
• Represent the organization to support establishment of an R&D laboratory near the Civica manufacturing site including hiring of R&D process scientists as necessary.
• Mentor and motivate team members and junior associates while coaching them through activities such as bench studies, pharmaceutical product development data analysis, FMEAs, combination product development, QbD, DoE, validation requirements, vendor interactions, material, and component specifications.
• Work closely with both functional and project managers to identify and mitigate technical issues and manage project milestones to adhere to project timelines. Serve as designated representative for pharmacy license.

• Bachelors, Masters, or PhD degree in pharmaceutical sciences, chemical engineering, or related disciplines with a minimum of 12 years in…