Covance Study Director-QC Scientist II-BioCMC in Greenfield, Indiana
Are you looking to join an expanding team with scientific leadership opportunities? Does the field of cell and gene therapy pique your interest? Do you enjoy a variety of scientific methodologies and bringing medicine to patients? If so, then we might have the right career opportunity for you!
Our Greenfield Covance site is currently recruiting for a QC Scientist to join the Biopharmaceutical Chemistry Manufacturing Controls (CMC) division. The CMC division provides end-to-end analytical solutions and testing services to ensure quality control of our clients manufactured drug products. We work with leading pharmaceutical and biotech clients to ensure that their manufactured drug product or API (Active pharmaceutical Ingredient) passes all quality testing. Once this testing is complete, it brings our clients one-step closer to successfully launching that drug product on the market.
The QC Scientist will join the expanding Biodistribution/Molecular Biology team in the CMC division and will be responsible for managing and directing studies on behalf of our Clients for analytical testing of key cell and gene therapy molecules. Job responsibilities are similar to that of a Study Director (GLP) or Responsible Scientist (GCP), and the appropriate candidate would be expected to deliver results in a fast paced environment. The team works on all aspects of the drug life cycle, from research and development through to commercial release material. We support biodistribution, persistence and shedding studies, clinical trials and stability material for our Clients in our dedicated PCR and virology suites. The ideal candidate should have a good working understanding of GLP and GCP regulations within this field and 5 years’ experience within industry or a CRO would be preferred.
ESSENTIAL JOB DUTIES:
With appropriate levels of support, apply critical thinking and application of knowledge to discuss techniques/procedures within team and externally (e.g. during cross training, with clients and during QA inspections)
Draft answers to study related audit comments
Actively participate in client discussions around technical aspects of studies
Through active mentoring, learn to:
Manage more complex client requirements to rapidly on board new client projects
Design standard protocols
Perform scientific review and approval of complex study reports and analytical data
Be a credible resource for scientific escalation of analytical techniques
Through active mentoring, gain confidence leading scientific discussions with the client
Document work and maintain study documentation and laboratory records.
Recognizes deviations from expected results and recommends appropriate action.
Plans and implements method development projects and studies in compliance with appropriate SOPS and regulatory guidelines. Develops, modifies, validates, and performs
methodology for routine and/or non-routine analyses.
Identifies and takes appropriate action with problems or potential problems with multiple technical assays in technical area of responsibility.
Ability to develop and implement an action plan for solving project or technical problems as they occur.
Support the implementation of startup priorities, systems and SOPs for the Biodistribution group.
Promotes a cohesive team environment.
Leads project meetings - Plans, monitors and guides the project work.
Lead and develop others in the duties to ensure study related activities are completed on time by:
Leading effective and concise communication and lead study start up meetings and ongoing study meetings with team members
Have the ability to listen and discuss ideas in an open and professional manner
Support resolution of escalated operational issues
Able to communicate project/study specific requirements to ensure understanding by all team members
Provide constructive feedback
Independently reviews scientific content accuracy and study validity in protocols and reports prior to Sponsor review
Write, revise, and review complex, technical SOPs and methods for compliance with regulatory guidelines.
Trains and may oversee less-experienced staff in aspects of operation of area of technical responsibility.
Participates in client visits as needed, assists in communicating technical information.
Able to review work of others for overall accuracy, timeliness, completeness, and soundness of technical judgment.
Assists in evaluation of data for incorporation into written reports.
Participates in process improvement initiatives.
BS/BA degree in science or related field
Graduate degree strongly preferred
Strong ability to learn is required
Demonstrates excellent oral and written communication skills
Strong interpersonal skills
3+ years of experience in the biotechnology, biopharmaceutical or pharmaceutical industry
6+ years of scientific experience relevant to the technical area of responsibility
Broad based technical experience and demonstrated ability to learn is required
Experience with equipment and analysis related to technical area of responsibility is required
Experience in a high throughput regulated environment strongly preferred
GLP compliance experience preferred
CLIA compliance experience would be a plus
GMP compliance experience would be a plus
Experience with laboratory-related computer systems is preferred
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.
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