Biologics Development Scientist Process

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AbbVie Westport have a number of new openings in our Technical Operations Department for Biologics Development Scientists.

These roles are offered on a Fixed term contract basis initially of lengths varying between 9months to 2 years. 

The role of Biologics Development Scientist will work as part of our dynamic New Product Introduction team on site in Westport reporting to the Senior Manager.

The successful candidate will be a technical lead for projects and assigned NPI programs and represent the business to external stakeholders. This role involves providing technical support to the business as well as specific manufacturing process tech transfers (NPIs) for one or more products.

In this role you will also support dayday operations activities within the NPI function and involve in coaching manufacturing operations staff on the clinical and proposed commercial manufacturing processes.  

Other aspects of this role are QMS Instrument validation compiling and review of project documentation (e.g. SOPs methods Master records Batch Records Reports). The successful candidate will be coordinating with several departments to holistically develop technical and leadership skills.

This is an exciting opportunity to pioneer new and innovative ways to implement new products to site and improve existing processes which have a remarkable impact on patients lives

Responsibilities will include:

• Identification and smallscale/ atscale development of continuous improvement projects. Working closely with process engineers and other departments to deliver these continuous improvement projects
• Execution of process development on existing products or new latestage clinical products including scale up to plant equipment
• Work with multiple departments as a part of routine work especially QA PDS&T and validations.
• Provide onthefloor technical support to the Production Team Leaders for process/equipment optimization and troubleshooting
• Provide technical support to all manufacturing and chemistry related issues. Tasks include daily trouble shooting optimization cost reduction training and coaching of manufacturing personnel
• Development of process control recipes for NPIs and optimization of existing commercial process recipes
• Coaching and training of all manufacturing personnel on technical/ chemistry elements of department operations Maintains regular contact with the other departmental team leaders and management to ensure all site operations are operating effectively
• Adhere to and engage in all site Safety rules programs and initiatives.
• Authoring and reviewing batch records protocols and reports.
• Work in accordance with the AbbVie Ways We Work.

Qualifications :

• Graduate with 5 years GMP experience postgraduate with 3 years of  GMP experience or Ph. D with 2 years of experience in GMP manufacturing in relevant science field. Experience with aseptic fillfinish is required.
• Detailed Knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry and drug product manufacturing is preferred
• Ability to work seamlessly in a crossfunctional environment communicate and manage stakeholders and establish as a technical SME within the team.
• Demonstrated coordination skills including the ability to deliver projects on schedule within budget and meeting the predefined requirements are required
• Must be a selfstarter with the ability to work on own initiative.
• Flexibility of working hours may be required and shift work may be required upon request
• Excellent communication and interpersonal skills for interaction with internal departments (QA Validation PDS&T IS EHS)
• Good time management organizational and technical writing skills.
• Able to work in a fast dynamic environment whilst being able to adjust readily to meet competing priorities and deadlines

Additional Information :

Interested Apply today and be part of groundbreaking work that transforms lives.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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