Biologics Development Scientist (Process)

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

Job summary

Join a forward-thinking organization where your expertise as a Biologics Development Scientist can significantly impact patient lives. This role offers the chance to lead innovative projects within the Technical Operations Department, focusing on new product introductions and continuous improvement initiatives. You will collaborate with cross-functional teams, providing essential technical support and coaching to manufacturing staff. With a commitment to fostering a supportive environment, this opportunity allows you to grow your career while making meaningful contributions to the health care industry. If you're ready to make a difference, this position is for you.

Qualifications

• 5+ years of GMP experience or equivalent in a relevant science field.
• Knowledge of cGMP and regulatory requirements in pharmaceuticals.

Responsibilities

• Lead technical support for NPI projects and manufacturing process tech transfers.
• Develop and optimize manufacturing processes and recipes.

Skills

GMP experience

Aseptic fill-finish

Project coordination

Technical writing

Communication skills

Time management

Education

Graduate degree in relevant science field

Post-graduate degree

Ph.D. in relevant science field

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and Tik Tok.

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 9 months 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-to-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 troubleshooting, 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, serving our community and embracing diversity and inclusion. It is AbbVie’s 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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https://www.abbvie.com/join-us/reasonable-accommodations.html.