Job Opportunity

Job Opportunity

Senior Process Scientist

Senior Process Scientist

Ireland Posted 2024-10-08

Senior Process Scientist (MFG 6.1 Upstream)

The Senior Process Scientist (MFG 6.1 Upstream) will play a pivotal role in establishing the Manufacturing Technology team, with responsibility for providing engineering support to the ongoing requirements for Manufacturing 6 and 7 as well as supporting any future tech transfer projects into MFG 6 & 7. With minimal supervision, this role focuses on process monitoring, troubleshooting, including leading/supporting major process investigations at the request of business, implementation of cost reduction projects, facility and equipment design specification. A core function of the role will ensure on-going optimization of the manufacturing process from ideation to execution whilst providing day-to-day support to the manufacturing shift teams to ensure manufacture of product in accordance with schedule, ensuring a supply of high quality biologic products meeting our company priorities.

The scope of this role will also ensure delivery of process excellence and reliability across all areas of the manufacturing process. The Senior Process Scientist will also provide input to ensure the facility design meets end user requirements.

Organization Description

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU and Asia. We currently employ over 10,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies.

Department Description

As Senior Process Scientist, you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you’ll be reporting to the MFG Technology Lead.

Your Responsibilities

Essential duties and responsibilities of this role include and are not limited to the following;

As project function lead (FL) or function sponsor (FS), providing support to FL) from the relevant manufacturing area
1. For new project introduction or feasibility fit assessment, work closely with MSAT, PM, BD and/or BDM department with minimal supervision from area AD and MFG lead.
2. Interface with the project teams / cross-function team to ensure the manufacturing facility will operate as per the user requirements.
3. Within the MFG department, lead the project related document preparation including, but not limited to MBR. Review all project related documents with cross-department, identify gaps and provide solutions.
4. Support cross-function (MSAT, SCM, etc.) for the introduction of new or alternate consumables or raw materials for project material readiness.
5. Provide expertise to the manufacturing area Associate Director (AD) and ensure all necessary plans are executed and delivered on time for all clinical and commercial stage production.
6. Participate in cross-functional project teams as applicable
7. Implement equipment CAPA’s and performance improvements, Conduct Investigation Trending as required
8. Provide input and work with the MFG leadership team to deliver the MFG objectives.

1. As Deviation owner or investigation lead, ensure investigations are closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented. Write equipment assessments to support investigation closure

1. Change Control write up and close out
2. Coach production personnel in manufacturing equipment as required for project or process related technical training.
3. Lead project summary or campaign summary, lesson learn & sharing.
4. Developing and maintaining a database for investigations, or other required department tracking and data analysis needs, as applicable
5. Provide equipment technical support and troubleshooting. Coordinate the delivery of a robust process and reliable equipment in support of a Right First Time Operating Unit.
6. Support audit preparation
Lead / provide Subject Matter Expert (SME) input into cross-functional teams investigating manufacturing process, environmental and water monitoring deviations including authoring investigation reports, technical assessments and summaries. She/he will work closely with the manufacturing area shift lead and team ensuring any actions and plans are clearly accounted for and carried out in alignment of plant operations plans. Provide coaching and support to manufacturing AD to develop process SME’s.
Ensure equipment is designed and tested to meet the requirements of the process, to ensure that the equipment continues to run as intended, that it is appropriately validated and maintained in that validated state.

Provide routine Automation support, troubleshooting and maintenance. Drive the use of PI to provide business efficiency.
Coach manufacturing team with manufacturing area AD’s supervision on OpEx tools and use OE systems as the basis for identifying improvements. Identify equipment improvement projects for Core Engineering Unit. Work with the portfolio management process to identify projects/support demands from the Core Units. Implement and support continuous improvements that reduce cycle times and operational costs
Champion and drive the implementation of Global Requirement Program tools and techniques within the Operation Unit. (for e.g. Operator Care, PdM, PMO, Work Management)
Champion and Support Energy saving programs/projects within the Operating Unit.
Complete biennial review and PQS updates.
Perform all duties in accordance with cGMP requirements, SOPS's and controlled documents.
Will be flexible to take on additional tasks and responsibilities at the discretion of the Technical Operation Lead (or Manufacturing area AD)
Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

Your Profile: The ideal candidate for this position will have the following:

Qualifications:

Third level qualification in a Science or Engineering related subject is preferable.
A postgraduate qualification in an engineering or science discipline would be advantageous.

Knowledge/Experience:

Minimum of 8 years’ experience in a large-scale in a Biopharmaceutical/pharmaceutical facility.
Ideally, experienced in establishing a Manufacturing Technology team in a ‘greenfield’ context of similar size and scale.
Excellent communication skills including computer literacy and ability to work independently and in a team.
Thorough knowledge of current Good Manufacturing Practices (cGMP).
Experience and knowledge of DeltaV MCS platform preferred.
Familiarity with Chromatography and Ultra filtration production operations is desired.

Behavioural Competencies

Strong leadership competencies with demonstrated management skills.
Excellent communication skills including computer literacy and ability to work independently and in team.
Strong leadership competencies with demonstrated management skills.
Ability to think critically and demonstrate troubleshooting and problem-solving skills.
Self-starter and self-motivated; organized with good attention to detail.
Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
Results oriented, with the ability to manage multiple priorities in a short period of time.
Collaborative and inclusive approach to work and colleagues.
Engage cross functionally in conjunction with a site-based team.
Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers’ expectations.

Other Requirements:

Must be willing to travel as required internationally to fulfil the responsibilities of the position.

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential!

If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission - Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now!

Would you like to know more before you apply? Please visit us at https://www.wuxibiologicscareers.ie or contact us via talentacquisition@wuxibiologics.com

WuXi Biologics is an equal opportunities employer.

Apply now