Manufacturing Support Scientist

My client is seeking to recruit a contract Manufacturing Support Scientist, reporting into the Associate Director for new product introduction within the Manufacturing group. This role is a key contributor to ensuring sustainable biologics manufacturing capacity within the company's network.

Responsibilities:

• Contribute to cross-functional teams (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain, etc.) for process improvement implementations, new product start-ups, or other process changes.

• Support new product introduction risk assessments to ensure the appropriate controls are in place to enable manufacturing.

• Assist in product changeover protocols to allow a smooth transition from sustaining to new product manufacturing.

• Represent Manufacturing at meetings to ensure end-user requirements are met.

• Support process technology transfer and preparation of manufacturing documentation for development, engineering, and PPQ batches.

• Identify process improvement projects for New Product Introduction and support them to completion.

• Collaborate with sustaining teams to understand current issues and ensure the impact of new products is defined, agreed, and understood.

• Write process impact assessments to support new product introduction.

• Provide SME input into cross-functional teams investigating and optimizing new manufacturing processes, procedures, and documentation.

• Deliver training to BPAs on new procedures.

• Support external and internal audits.

• Work with cross-functional teams on the introduction of consumables and raw materials to support New Product Introduction.

• Promote a "Right-First Time Culture" and provide leadership in the use of Operational Excellence principles.

• Support the disposition process when required.

• Manage organizational activities such as purchasing and coordinating communication information.

• Own and drive change controls, CAPAs, investigations, improvement projects, and operational safety initiatives.

• Minimize human error and work with operations to remove sources of error.

• Act as a departmental approver for operational procedures, electronic batch records, and other GMP documentation, while providing technical training and knowledge transfer to the Operations team.

• Support sustaining operations as needed to ensure product supply.

• Develop strong working relationships with Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources, and Finance.

• Support and implement new technology solutions such as Single-Use technology.

Qualifications and Experience Required:

• Strong communication and collaboration skills at various levels, coupled with excellent organization and planning abilities.

• Proven success in a team environment, with strong leadership and influencing skills, along with flexibility to adapt to changing business needs.

• Problem-solving and project management abilities, with lean manufacturing experience.

• Bachelor's or Master's degree in Science, Engineering, or a related field.

• In-depth theoretical knowledge of GMP biologics manufacturing equipment and process automation.

• Proven ability to support the closeout of complex technical investigations.

• Strong working knowledge of systems such as Delta V, MES Syncade, and SAP.

• Excellent presentation skills.