Associate Director Drug Substance External Manufacturing
Cpl are delighted to work with our pharmaceutical client partner to source an Associate Director of Drug Substance for their External Operations team.
In this new and exciting role as the Associate Director of Drug Substance, you will be a key stakeholder in the External Operations Manufacturing team with a Global brand leader in outsourced Pharmaceutical R&D and Manufacture.
With an interesting portfolio of products both currently in the market and an extensive portfolio of products in the R&D and development stage, this is primarily a Fully Remote role offering a tremendous degree of flexibility and the External Ops division are working in a very close partnership model with several CMO partners across the EU and USA.
The Associate Director of Drug Substance will be required to support and lead the Active Pharmaceutical Ingredient (API) processes with their client CMO partners in the USA and EU
You will also provide Technical Leadership for the companys Drug Substance (small molecule) introductions, Tech Transfer, scale-up, process monitoring, process improvements and additional projects on behalf of the parent company.
As the Associate Director of Drug Substance, you will be the subject matter expert responsible for being the technical lead supporting Active Pharmaceutical Ingredient (API) manufacturing at Contract Manufacturing Organizations (CMOs) and Suppliers that provide API for subsequent processing in Drug Product (DS) processes across Oral Solid Dosage (OSD) and Injectables.
You will be required to provide technical leadership for Drug Substance (small molecule) for new product introductions, technology transfers, process scale-up, process monitoring and troubleshooting and improvement projects at CMOs on behalf of the parent company
Fostering a continued Business Partnership for the Associate Director of Drug Substance
- In your role as AD of Drug Substance, you will establish strong working relationships to build partnerships based on trust with CMOs through internally established communication forums.
- A key role for you will be to partner with Commercial Supply Chain, Supplier Relationship Management, Quality, EHSS, R&D and other functions as required across the internal network to deliver value for the pre-aligned business goal.
- As the AD, you will focus on developing strategic business decision recommendations for strategic/business decisions and you will also provide the wider management group with accurate and timely information necessary to make strategic, investment and operating decisions.
- One of your key tasks as Associate Director of Drug Substance will be to draft, review and prepare a range of CMO competency assessments to ensure robust decision-making processes when it comes to supplier selection and supplier optimisation discussions with senior management to continue to meet the business key directives and targets.
- You will help and support with facilitating the transfer of new products and development projects to sites through the development of effective business cases and management support.
- As the Associate Director, you will also be required to Preparation of credible and reliable business plans, budgets, and forecasts.
- Foster and promote a continued culture of External and Internal collaboration with all of the stakeholders in the business.
- Ensure support and integration of Technical Operations with relevant functions in order to achieve customer service objectives.
Key skills and requirement for this role
Ideally as the AD of Drug Substance, you will hold a Third Level qualification in chemistry/chemical engineering or relevant engineering/scientific discipline, preferably multi-disciplinary with a strong technical/scientific orientation.
You will be able to demonstrate a particularly strong understanding and experience of technical/scientific challenges in production processes ideally across both Drug Substance and Drug Product processes with proven track record demonstrating issue resolution.
A minimum career history of 8-10 years progressive career experience is essential
You will have at least 3 years in a Senior Manager or AD role within Pharmaceutical or Biotech manufacturing and preferably with CMO experience
Additional and ideally preferred skills could also include
Being familiar or having worked with and or alongside Process Safety in API environment.
Lean/Six Sigma qualification at Green Belt or above obtained and certified by an Internationally recognized body in a pharmaceutical / medical device setting.
The core personal traits and skills required
You have a proven ability and track record to foster and promote internal and external collaboration.
You have the proven ability to thrive in a virtual dynamic environment.
You are logical and problem-solving skills with a very high level of customer orientation.
Youre an accomplished senior Pharma or Bio Pharma professional who has a natural ability to balance team and individual responsibilities.
Although this is a primarily remote role, there is also a possibility of 20% of domestic / international travel associated with this role.
If you see this as either the next step in your career from Senior Manager or if you are already at an AD level, and youre interested in a career change to an extremely dynamic company who are a recognised heritage brand in the International Pharma industry and who have a manufacturing footprint in Ireland since the mid 1980s, then please send me your CV in complete confidence.
Ill review and respond to you within 48 hours and we can arrange a confidential call back at your earliest convenience.