Associate Director - Drug Substance Process Operations

MSD

Dunboyne, Co Meath
Permanent
Full-time

1 month ago

Job DescriptionA new opportunity has arisen for a Drug Substance Process Operations, Associate Director (DPSO AD) to join the team at our newly constructed state Biologics Innovation facility located at our company site in Dunboyne, County Meath, Ireland.The Biologics Innovation Xceleration facility, is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility supports seamless connection and collaboration within and across teams and functions. The site provides Biologics Drug Substance and Cell Banking manufacturing for Clinical Supply, Registration & Commercial Launch.The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change. A multi-product strategy for Technology Transfer and Facility Fit will enable the facility to adapt in a flexible and agile way for rapid product launch. The DPSO AD will be a member of the site Manufacturing Leadership team, reporting to the Head of Manufacturing. The successful candidate will be a key stakeholder in the deployment of the multiproduct strategy and will coordinate the introduction of new processes, materials, and technologies to the facility, as well as transfer of processes out. The successful candidate will be critical to the success of the facility to meet an accelerated Clinical Commercial-ready schedule.The Associate Director of Drug Substance Process has a variety of key responsibilities.

Leading a team engaged in both day-to-day production execution and strategic activities aimed at improving the time-to-market for future Clinical or Commercial campaigns.
Overseeing the coordination efforts for Drug Substance Manufacturing Execution (DS Process Operations) intended to meet the requirements of New Product Introduction (NPI) schedule.
Management of the Operations team, which includes hiring and building team capabilities to meet the operational requirements of the facility.
Embedding a culture that aligns with the Ways of Working and is committed to both the facility and site priorities.
Overseeing production planning and associated activities, integrated with the facility Multiproduct platform.
Championing the implementation of the lights-out manufacturing philosophy. Establishing a working rhythm that allows for agility and movement of staff between Cell Expansion, Process Platforms for Fed Batch and Continuous Manufacturing, and Solution Supply. This includes designing a flexible skill matrix for training aligned with the working rhythm.
Ensuring operational readiness in cross-functional partnership with other key stakeholders, as required by each Tech Transfer program to the facility. This involves engaging cross-functionally to deliver site-based activities related to the program. Designing a strategy for product-specific adjustments and participating in associated platform Quality Risk Assessments (QRA).
Accountable for the management of the Production Alarm System, Sample Management Processes (GLIMS), Change approver for MES, Delta V Recipes, and material BOMs, Manufacturing approver of process descriptions.
Deploying manufacturing and associated release standards in compliance with the company's Quality Manual and collaborating with network partners for a common approach.
Supporting the deployment of phase-appropriate Quality Management Systems (QMS) within the facility, including Change and Deviation Management.
Developing future breakthrough business solutions, initially leveraging existing resources in the company's network to reduce overall effort and risk and optimizing these solutions to facilitate rapid product launch.
Collaborating across the network on sharing best practices and lessons learned, embodying an enterprise mindset in looking at what can be leveraged across the network to reduce work that needs to be done locally.

The successful applicant will have the following education, skills, and experience:

Degree level qualification in science or engineering.
Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
Proven experience in a leadership role with technical transfer experience in the biotech sector in any/all the following: Clinical Supply, Registration & Commercial Launch.
Possess a deep understanding of a manufacturing/operational GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of both upstream and downstream processing being a significant advantage.
Delta V and MES (Manufacturing Execution System) knowledge and experience an advantage.

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.So, if you are ready to:Invent solutions to meet unmet healthcare needs, please apply today.Current Employees applyCurrent Contingent Workers applySearch Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation: InternationalVISA Sponsorship:Travel Requirements:Flexible Work Arrangements: Not ApplicableShift:Valid Driving License:Hazardous Material(s):

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