Covance Senior Lead Scientist II in Greenfield, Indiana
The Senior Lead Scientist ensures that the studies are carried out to the required standards and that all work is conducted in compliance with applicable regulatory requirements and specifically those regulations (GxP) specified in the study plans, protocols, or work agreements governing the work in which they are involved. The Senior Lead Scientist serves as the main point of contact for analysts and clients and ensures that client deadlines are met. They are also responsible for providing guidance to both the clients and laboratory operations as it relates to the analytical strategies and experimental design. The Lead Scientist is the primary point of study control and has overall responsibility for the scientific, technical and regulatory conduct of studies allocated to him/her as well as for the approval of study data, interpretation, documentation and reporting of results. Close and regular liaison with the client is of primary importance. In addition to the items mentioned above, the Senior Lead Scientist will lead the identification and implementation of new technologies that will drive growth in Biopharmaceutical CMC Solutions. Furthermore, the Senior Lead Scientist will drive scientific excellence throughout the organization by disseminating information that they gather from attendance at conferences, symposiums, and consortiums to the rest of the organization.
The duties of the Senior Lead Scientist in our Biopharmaceutical CMC Solutions team include:
Lead the identification and implementation of new technologies that are critical to the growth of the Biopharmaceutical CMC Solutions team
Serve as a thought leader in the Large Molecule CMC space by actively participating in conferences, symposiums, and consortiums.
Provide consultation to clients as it pertains to the design of analytical strategies needed to support development of Biologics
Work closely with laboratory personnel to ensure that the study is performed in accordance with the study protocol and the Covance standard operating procedures to ensure that the study is performed to the required scientific and regulatory standards.*
Serve as an expert in a relevant field and design and troubleshoot assays and perform hands-on activities as needed.
Design study protocols and write study reports to meet client and regulatory requirements.*
Provide in-depth and up to date knowledge of GMP regulations as applicable; coordinate and manage organization of multi-site studies.*
Hold ongoing study meetings and provide client feedback to team. Be aware at all times of study status and anticipate problems that may affect timing, quality, etc. and work with operations taking appropriate action to resolve such problems and prioritize analysis for clients.
Be responsible for on time delivery targets (protocols/results/reports).
Constructively participate in departmental meetings, team meetings, scheduling etc.*
Ensure that all study communication is documented and maintained and carried out to meet client requirements.
Proactively manage client and study changes to meet timelines and ensure all changes (timelines/costs etc.) are captured and communicated to business development and project management.
Provide in-depth knowledge of relevant assays, advise internal / external clients on standard and novel study designs
Provide training to junior Lead Scientists as assigned.
Author and approve analytical methods as needed
Technically review analytical data
Approve GMP / non-GMP data reports, CofAs, etc.
Author and approve validation protocols & reports
Author and approve Stability protocols & reports
Perform study related GMP investigations, LIR, DEV, etc.
Perform study related CAPAs
Oversee development of novel assays
- B .S. or M.S.with 10 years of relevant experience or a PhD with 5 years of relevant experience. Relevant experience will have been gained in directing studies within the department or within a similar role external to Covance. In addition, client management experience and technical expertise in the relevant business line will have been gained prior to this role. The job holder will have developed skills and competencies in the basic study types.
The Senior Lead Scientist shows proficient computing skills, including word processing and use of spreadsheets (e.g. Word, Excel). Previous experience with statistical software, project management software, and sample management system is preferred. Experience with Covance internal system, such as eQA and CMS, is a plus
The Senior Lead Scientist should possess an in depth understanding of Health and Safety policies, Company Policies and Procedures, and GxPs.
The post holder should be able to communicate effectively with other Covance employees, as well as external Clients and suppliers etc
Expertise in Gene and Cell Based Therapies and/or Cell-based Assays
Job Number 2018-18804
Job Category Scientific Advanced Degree
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.