The applicant will be responsible for cell-based characterization assays, including dose-response potency methods for commercial protein drugs in the Rockville MSAT analytical team. You will provide testing and scientific analysis for comparability studies and for analytical investigations. The applicant will be the MSAT subject matter expert for cell based bioassays and represent MSAT in meetings with other GSK departments.

You will transfer-in characterization methods from Research & Development / Clinical departments to implement and execute them. You will also utilize your expertise to lead method troubleshooting root cause analysis for issues arising in our or other departments. Cell-based methods will be carried out in a BSL2 and GMP environment. You will provide testing and scientific analysis for comparability studies and for analytical investigations. In addition, you will have the opportunity to participate in non cell-based characterization analytical methods for process residuals or protein quality.

To achieve your objectives, you will work closely with the QC Bioassay and R&D departments. For the MSAT analytical department, this will be an expansion of scope and the team will rely on your expertise to cover bioassays.

Accountability:

Key accountabilities of the role are:

• Serve as a project lead for DS and DP cell-based characterization assays within MSAT: Method transfer and execution
• Primary contact and subject matter expert for cell-based bioassays in MSAT
• Strong working relationship with QC Bioassay leadership and personnel
• Represent MSAT Analytical group in matters of cell-based assays in meetings and documentations
• Working in a GMP and BSL2 environment
• Adhere to documentation rules when working with GMP equipment
• Be able to work independently without direct supervision
• Flexibility to learn/execute non-bioassays, primarily process residuals
• Strong oral and written communication skills

Documented experience with the development and execution of reporter-based assays using luciferase or other similar systems to measure the response in cell systems

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• BS with a minimum of 8 years, MS with a minimum of 6 years, or PhD with a minimum of 2 years industry experience
• Experience in GMP environment

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Understanding of the mechanism of antibody drugs
• Experience in method troubleshooting
• Experience in method development, qualification, or validation.

Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Get Ahead Together.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Rockville, MD 20850: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Biopharmaceutical: 8 years (Required)
• CGMP: 5 years (Required)

Work Location: In person

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