The Multi-Product Cell Culture (MPCC) Facility 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.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance and Manufacturing
Industries
Pharmaceutical Manufacturing
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