Senior R&D Scientist (LC-MS)

About LabCorp Drug Development:

As a leading contract research organization, LabCorp provides comprehensive drug development solutions for a range of industries. We are a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Together with our clients, we support the development of innovative, life-changing treatments.

The Role:

Our US site in Greenfield, IN is currently recruiting for a Senior Assay Development Scientist, specializing in LC-MS techniques, to join the CMC (Chemistry Manufacturing Controls) team.

The CMC business unit provides dedicated release and stability testing from preclinical phases through the commercial life of a product. The CMC team support method development, transfer, phase appropriate validation & assay establishment of large molecules. We structure ourselves to deliver scientific expertise to our clients; collaborating closely with them to support the development of medicinal products through the drug development process and onto market.

Key job responsibilities include:

• Development and establishment of LC-MS assays (QToF) for use within BioPharm CMC lab operations in a GMP environment, in addition to completion of non-regulatory characterization and internal innovation projects

• Development, transfer and optimization of analytical methods, in accordance with client requirements and associated protocol and procedures

• Acting as a Subject Matter Expert in LC-MS methods

• Having a comprehensive understanding of routine use, maintenance and trouble-shooting of Waters Vion IMS LC-MS system and engaging with representatives of instrument, software and consumables suppliers

• Assisting in equipment and software purchases and subsequent evaluation, installation and qualification processes

• Managing the scientific process associated with studies assigned to them, including review and approval of data and documentation where relevant

• Liaising with clients, QC operational teams, project managers and GMP Quality Assurance to ensure client studies are carried out to proposed timescales and regulations

• Managing the scientific discussion with clients and providing advice on scientific escalation and assay troubleshooting where necessary

• Prepare and present scientific posters, manuscripts and papers that demonstrate expertise and enhance the reputation of Labcorp in the scientific and client community

• Proposal and implementation of innovation projects for the strategic and scientific growth of the business

Education/Experience:

• Educated to BSc/MSc/PhD in an appropriate scientific field

• A minimum of 4 years proven experience in the development of LC-MS assays for the characterization and analysis of proteins and mAbs and their associated Critical Quality Attributes (CQAs)

• You will be able to clearly demonstrate your skillset and success in the development of fit-for-purpose LC-MS methods for multiple therapeutic product types, including peptide mapping, intact mass and middle-up methods

• Excellent communication skills, with the ability to work with individuals in wide ranging teams at all levels and the ability to lead and influence

• In depth knowledge of GMP regulatory guidelines applicable to analytical methods

• Experience in LC-MS analysis for one or more of the following therapeutic areas is a distinct advantage: Forced Degradation, Formulation Development, Adeno-associated virus (AAV), Gene and Cell Therapies, Oligonucleotides or mRNA vaccines

What Labcorp Drug Development can offer you:

• A comprehensive onboarding training plan covering laboratory, technical and regulatory training packages.

• Unsurpassed career development opportunities, with the ability to develop your technical and managerial skills.

• Ability to work with a variety of different clients on wide ranging projects.

• Competitive salaries and a comprehensive benefits package including health cover and contributory pension.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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