CDS SPRAY DRYER COMMERCIALISATION & IPT TECHNICAL LEAD

Job Description

We have an exciting opportunity for SPRAY DRYER COMMERCIALISATION & IPT TECHNICAL LEAD to join our Ballydine team. Reporting to the Pharm Technical Head of Commercialisation Development and Supply (CDS), the incumbent manages the provision of technical support to the Ballydine Spray dryer facility. This includes the Commercialisation (new product introduction) and Commercial Supply of Spray Dried Intermediates (SDI) and the transfer of new or existing SDI processes and technologies to plants and external parties. The incumbent is also responsible for discovering, developing, and implementing, process improvements and for the provision of technical support to the Integrated Process Team (IPT).

Essential Duties and Responsibilities include, but are not limited to, the following:

• Technical Expertise: You will stay up to date with the latest developments in spray drying processes, both within our organization and externally. You are expected to use this knowledge to coach your colleagues and help achieve our overall divisional goals.
• Project Development: You will be responsible for creating and prioritizing development plans across multiple projects. This includes working proactively with leaders in other functions such as Quality, Analytical Development, and Integrated Process Team (IPT) to ensure our work is optimized across multiple groups to maximize our impact on the project portfolio.
• Technical Support: You will provide direct technical support to development, clinical, and commercial supply production for our spray dried processes, which involves evaluations of raw materials and the optimization of SDI processes. This extends to participation in campaign preparation and follow-ups, safety and environment reviews, batch sheet reviews, and more.
• Engineering Support: You will direct the technical support for process development activities associated with new processes in Development, Clinical Supply, and Process Performance Qualification through to Supply. This requires a full understanding of the process/formulation and engineering issues associated with new Spray Drying processes.
• Resource Management: You will provide the technical resources needed to support the IPT in achieving profit plan targets by meeting operational targets, managing the impact of changes, and ensuring a timely and compliant closure of process deviations and other process-related incidents.
• Safety and Compliance: You are responsible for ensuring that all work is conducted safely and in compliance with current Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements.
• Team Development: You'll also be expected to develop your team by delegating tasks, providing feedback, and offering opportunities for professional growth.
• Administrative Duties: As part of the administrative role, you will handle the compilation of various reports, budgetary considerations, and other administrative tasks necessary for the running of the department.
• Participation in HR activities: You will contribute to employee recruitment, development, and assessment programs, and directly input into the implementation of the site human resources plan and organizational development.
• cGMP Compliance: You will be accountable for ensuring assigned processes/systems managed are carried out in conformance with site divisional and corporate quality standards, and that all deviations from standards are thoroughly investigated and corrected. This includes being the Sub-System Owner for various Quality Management System sub-systems.

The ideal candidate will possess:

• Educational Background: We require a BSc/BEng or higher in Chemistry, Manufacturing, Engineering, or a Science discipline.
• Technical Knowledge and Experience: A minimum of 10 years of relevant industry experience, with a significant portion of that time focused on enabled formulations/spray drying, is a must. You should be well-versed in the processes and formulation development specific to spray drying and possess a deep understanding of the engineering principles involved in spray drying. Familiarity with process, equipment, and cleaning validation, as well as cGMP's and regulatory requirements, is required.
• Production Insight: You should have a thorough understanding of production operations, MBR Batch System and Recipes, Deviation Management, Change Control, and Procurement Systems.
• Business Acumen: Along with technical expertise, you should possess productive communication and interpersonal skills, demonstrated ability in strategic thinking and problem-solving, and have a clear understanding of financial management. Project management skills, customer service skills, and efficient time management will be value-adding traits.
• Leadership Qualities: You should have the ability to work in partnership with site functions and external partners, including PCT, and our Manufacturing Division groups in areas related to spray drying formulation, process development, process equipment, process operations and validation. We need someone who can communicate effectively, evaluate projects technically, and manage a diverse range of projects in a changing environment.
• Ethics and Integrity: Above all, we value honesty, respect for people, and commitment to ethical behavior. You should be able to demonstrate an ability to embrace diversity and inclusion, and always put patients first.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date: 06/10/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R294539