Biologics Development Scientist (Process)

TN Ireland; Westport (CT); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Biologics Development Scientist to join their dynamic New Product Introduction team in Westport. This role offers an exciting opportunity to lead technical projects and support innovative manufacturing processes that significantly impact patients' lives. With a focus on continuous improvement and cross-functional collaboration, you will play a crucial role in optimizing operations and ensuring compliance with GMP standards. If you're passionate about making a difference and thrive in a fast-paced environment, this position is perfect for you.

Qualifications

• 5+ years of GMP experience required.
• Experience with aseptic fill-finish is essential.
• Excellent communication and interpersonal skills needed.

Responsibilities

• Identify and develop continuous improvement projects.
• Provide on-the-floor technical support to production teams.
• Author and review batch records and protocols.

Skills

GMP experience

Aseptic fill-finish

Communication skills

Project coordination

Technical writing

Education

Bachelor's degree in relevant science

Post-graduate degree

Ph.D. in relevant science

Job description

Social network you want to login/join with:

Biologics Development Scientist (Process), Westport

col-narrow-left

Client:

AbbVie

Location:

Westport, Ireland

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

43473d3aaa7f

Job Views:

3

Posted:

25.04.2025

Expiry Date:

09.06.2025

col-wide

Job Description:

Job Description

If you want to be a difference maker our people are waiting. See the difference you can make at AbbVie.

Working at AbbVie is more than a job. It’s a career with meaning. A chance to make a difference, in the world and in your life. We make sure you have everything you need to reach higher ground in your career. From growing and learning together to fostering a supportive space for you to thrive—at AbbVie and beyond.

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 day-day 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 small-scale/ at-scale 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 late-stage 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 on-the-floor 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, post-graduate with 3+ years of GMP experience or Ph. D with 2+ years of experience in GMP manufacturing in relevant science field. Experience with aseptic fill-finish 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 cross-functional 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 self-starter 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html