QC Scientist II-Cell Based Assays

The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job.

Job Summary:

Working as part of the QC Laboratory Operations Group, the QC Scientist routinely manages a number of assays pertaining to common techniques. Typically, the QC Scientist will be responsible for single projects (for one or several related techniques), may be part of a larger cross-sectional team leading small to medium multi-technique projects (as a molecule lead), or be part of a larger cross-sectional project working in conjunction with a more experienced QC Scientist or Lead Scientist.

Project requirements may include, but are not limited to; assay transfer, validation, sample analysis, batch/release testing, and stability studies. They will write protocols and reports, prepare and review analytical procedures, and be accountable for the approval and integrity of data and associated quality documentation.

The QC Scientist has knowledge within a relevant field and is able to troubleshoot techniques in the area of their expertise. The management and approval of assay data by the QC Scientist forms a large area of responsibility for GMP projects.

They may also be required to act as a Study Director or Principal Investigator for GLP projects, or Responsible Scientist for GCP projects. The QC Scientist is therefore required to adapt to changing regulatory requirements, depending on project types.

In this role, the QC Scientist will provide internal customers with a central scientific point of contact for techniques within their area of expertise, or for external Clients where the QC Scientist is not the molecule lead. The individual is accountable for effective communication either directly with the Client or via the molecule lead to ensure that Client requirements and project deliverables are met. This includes discussion with the Project Management Office (PMO), molecule lead if applicable, and communication with QC Section Managers, as well as other scientific and analytical staff. The QC Scientist has scientific oversight of relevant techniques in order to ensure the successful initiation, planning, execution, monitoring and completion of projects.

The QC Scientist is required to have good working knowledge of the GMP/GLP/GCP and regulatory guidelines as they ensure that projects are carried out to the required standards, and that work is conducted in compliance with applicable regulatory requirements.

The QC Scientist will be responsible for overseeing the work of other QC Scientists where appropriate. They will be expected to train, coach and mentor members of the team and across functions as required.

The individual will work with more experienced QC Scientists or molecule leads to identify and communicate scientific and regulatory developments within their field of expertise, to include QA, management, Lead Scientists, QC Scientists and Laboratory Analysts. The QC Scientist may represent Covance internally or externally by preparing and/or giving presentations, writing or supporting the preparation of scientific papers and/or posters, in order to communicate the work of Covance QC laboratory operations.

The QC Scientist will be required to perform lab work as required, and provide support with regards to general laboratory operations and processes, leading by example to members of the QC operations team.

The post holder will adhere to the BiopharmCMC SOPs and will be responsible for completion of all relevant documentation.

People Responsibilities:

The position may be associated with line management responsibilities. Additionally, project specific supervision will be required as appropriate.

Essential Job Duties:

Initiation

• In support of project initiation and proposals, participate in conference calls and Client visits as required.

Planning

• Perform and review gap analysis for Client methods being transferred in your area of expertise.
• Knowledge of the client requirements and plan accordingly to meet Client deadlines.
• Ensure Health and Safety information (including GMO risk assessments if applicable) are in place and are readily accessible.

Execution

• Participate in and/or conduct project meetings.
• Attend client conference calls and meetings for specific technical requirements arising during projects.
• Work across all operational sections and other departments/sub-contractors associated with a specific project to achieve overall milestones.
• Prepare and approve project protocols and amendments. Ensure that the required regulatory, scientific and client requirements are captured.
• Perform content review of standard protocols for all assay types e.g. development, validation, sample analysis, release testing etc.
• Ensure assays are performed in accordance with the protocol, Client requirements and Covance Standard Operating Procedures (SOP).
• Complete test schedule (where appropriate).
• Coordinate or facilitate the scheduling or management of lab work, where necessary.
• Where appropriate, write or manage validated Analytical Procedures (AP), Client Methods, Working Documents (WD) and/or Workbooks, and competently review these documents.
• Perform lab work as required.
• Review and approval of regulatory (GMP/GLP/GCP) data.
• Write (where appropriate) assay based quality documents - Quality Events, Risk Assessments, CAPAs, Change Controls, Out of Specification (OOS).
• Perform tracking/trending and subsequent interpretation of assays and feedback to Operations and Clients as appropriate. When acting as molecule lead on more complex study types, review tracking and trending and feedback any potential issues to Operations and Client as appropriate.
• Identify and communicate adverse events to management and seek and find solutions to problems.
• Ability to problem solve unexpected analytical events within projects/assays, and issues within the wider group.
• Prepare project reports and Certificates of Analysis (CofA), and approve these documents where necessary.
• Accountable for QA and Client comments on Protocols and Reports where necessary.
• Ability to make decisions on assay results/data.
• Write and approve assay investigation reports.
• Adhere to Quality Agreements and be aware of QC Scientist and Covance responsibilities.

Monitoring and Controlling

• Be aware of the study or assay status at all times and anticipate issues which may affect, quality, time lines etc. To be responsible for communication of the issues to all parties internally and to take appropriate action to resolve.

Closing

• Ensure all studies are archived in accordance with the current SOP.

General

• Manage batch testing, release testing, sample analysis, stability, assay development, establishment and/or validations/transfers
• Good working knowledge of relevant scientific and GMP/GLP/GCP guidelines.
• Act as a Subject Matter Expert (SME) within a QC Section.
• Knowledge of standard and non-standard study designs and the ability to draw scientific conclusions.
• Working method knowledge e.g. instruments used within the laboratories.
• Assist in the preparation/review of training modules in area of expertise.
• Mentors and develops others in the group through continuous and consistent feedback.
• Write and review Analytical Procedures, Polices, SOPs and Guides where appropriate.
• In-depth knowledge of study process from award to finalisation, archiving and amendments to final reports.
• Employ effective general management, communication and interpersonal skills to work within the project teams, with the Client and other project stake-holders e.g. supporting functions at Covance.
• Participate in client and regulatory audits when required.
• Perform revenue recognition where required.
• Responsible for on-time delivery of data, project documents, and quality documents.
• Ability to make decisions on assay results, suggest assay/technique advancements/improvements to the client, and follow through with the client as necessary

Travel Requirements

The role will be primarily office based. It is anticipated that Client visits / meetings will constitute approximately 10 to 20% of the time in this role. Client visits and conferences including possible weekend travel.

Language Skills Required

Excellent verbal and communication skills with all principal contacts on a regular basis. Required to communicate with Clients on a regular basis.

Experience

The post holder should typically have:

• Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project).
• An in-depth understanding of health and safety policies, Company policies and procedures, and a good understanding of GMP/GLP/GCP.
• The post holder should be able to communicate effectively at all levels with other Covance employees, as well as external clients, suppliers, etc.
• The ability to get things done by influencing others (both internal and external).
• Knowledge of capabilities and expertise of the Covance organization and companies that may provide support services.
• An up to date knowledge of regulatory guidelines.
• Commercial awareness, interpersonal and negotiating skills.
• Learn and maintain knowledge of process excellence processes, tools and activities.
• Experience will have been gained in similar types of study management (either internal or external).
• Experience of Client Management.
• Technical expertise in an appropriate scientific discipline.

Education/Qualifications/Certifications and Licenses

The post holder should ideally have a relevant degree and/or 5-6 years industry experience.

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