Associate Director of Product Development

Job Description

A leading company in the pharmaceutical industry is currently seeking an Associate Director of Product Development to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Key duties include:

1) Lead R&D activities for developing products to support BLA enabling product development.

2) Translate product development project requirements into a robust, scalable technical design

3) Resolve complex problems by applying sound engineering principles, utilizing experimental, and analytical methods to a range of technical product development challenges over a range of products from simple sterile injectable vial products to more complex pre-filled syringe disposable auto-pen injector combination products

4) 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

5) Support R&D leadership to build a diverse and capable product development team, supporting the areas of formulation, fill and finish, filtration and filling assembly build-up, device assembly, and inspection parenteral operations

6) Deliver technology Transfer Plan through product life cycle technology transfer, engineering, clinical, PPQ, and process validation, and control strategy development

7) Participate in and lead the development and implementation of product failure modes effect analysis, particle investigations, filtration and filling assemblies and root cause analysis

8) Support product preapproval inspection

9) Understand and implement manufacturing control strategy for various unit operation areas

10) Define BLA-enabling studies necessary for product submission and conduct those internally and externally with collaboration from different departments.

11) Review and approve cGMP documents such as product development Reports, batch records, technical reports, change controls, validation protocols, and summary reports

12) Represent the organization to establish an R&D laboratory at the Civica manufacturing site including hiring of R&D process scientists

13) Oversight and management of the development of Biosimilar aseptic products at the Civica site.

14) Work closely with both functional and project managers to identify and mitigate technical issues, manage project milestones to adhere to project timelines

15) Improve product development cycles and quality via the application of Quality by Design and Lean Product Development Tools

16) Guide multi-function teams comprising QA, Regulatory Affairs, Hospital network partners, Contract Development and Manufacturing operations team members by facilitating effective communication and engagement

17) 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, validation requirements, vendor interactions, material, and component specifications

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the pharmaceutical industry is strongly preferred

4) Preference will be given to candidates with recent experience in research and development

If you are qualified and looking to work with a well-established company – one of the top names in the industry – you should not let this opportunity pass by. However, for this Associate Director of Product Development role, you must be someone who is experienced and passionate about research and development.

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience