Process Manufacturing Scientist

Our client, a mainstay in the biopharmaceuticals space is seeking to hire a Manufacturing Project Scientist/Engineer on an initial 12-month contract. Our client is seeking to hire a Manufacturing Process Scientist on an initial 12-month contract. If you have a knowledge of upstream bioprocessing, cell culture and a background in the biologics particularly in the area of technology transfer this could be your next move. Reach out today for more info.

Job Summary:

The contract Manufacturing Support Scientist/Engineer will report into the Associate Director for new product introduction within the Manufacturing group. The Manufacturing Support Scientist/Engineer for New Products role is a key contributor and part of the team for sustainable biologics manufacturing capacity to the network.

Key Responsibilities:

• Contributes to cross functional team (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

• Support product change over protocols to allow a smooth transition from sustaining to new product manufacturing

• Represent the Manufacturing at meeting to ensure the end user requirements are represented

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

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

• Work with sustaining team to understanding current issues and ensure impact of new products are defined, agreed and understood

• Write process impact assessments to support new product introduction

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

• Provide 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 .

• Work to implement a “Right-First Time Culture” and provide leadership in the use of OE principles.

• Support the disposition process when required

• Carry out organizational activities such as purchasing & co-coordinating communication information.

• Own & drive change controls, CAPA’s, investigations, improvement projects and operational safety.

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

• Departmental Approver of operations procedures, electronic batch records and other GMP documentation and provide technical training and knowledge transfer to the Operations team.

• Support sustaining operations when required to ensure product supply

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

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

Qualifications and Experience required:

• Ability to demonstrate proficiency communicating and collaborating at a variety of levels, coupled with excellent organization and planning skills.

• Must have proven success working in a team environment, as well as strong leadership & influencing skills, with flexibility to react to changing business needs.

• Problem solving and project management ability, as well as lean manufacturing experience is essential.

• Currently completing a Bachelors/Masters in Science, Engineering, or a related subject.

• 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.

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