5616 QC Scientist IV/Project Manager

Summary:
The QC Scientist/ Project manager will be a member of the Protein Analytical Chemistry Validation Department (PAC-V).
PAC-V is one of the seven departments that comprise Analytical Development and Quality Control (ADQC) organization within Process Research and Development.
PAC-V is responsible for the validation life cycle of quality control methods (covering a wide array of techniques) until established as part of a commercial control system.
PAC-V is responsible for both the development and execution of the strategies.
The candidate will provide practical guidance to ensure the appropriate and timely progression of acceptable validation activities across the IMP QC Network.

The QC Associate / Junior Project Manager duties:
Perform technical writing, review and editing.
Review of GMP documents and relevant testing.
Support staff with tracking and development of timelines and activities.
Support training and development of staff.
Draft minutes and support meeting logistics.
Creates validation project plan (i.e., timelines and resources) and provides status updates to management and leadership teams.
Support to coordinate work activities and aligns resources across functional areas to achieve goals.
Train personnel and internal customers on relevant business processes.

Skills:
Experience in QC lab or Analytical Development is highly preferred.
The position requires the ability to work independently as well as part of a team.
The successful candidate must have good communication skills (verbal and written), must be detail-orientated and have the ability to work effectively in a fast paced, multi-disciplinary team environment.
Experience in a GMP environment is a plus, but not a requirement.
Work with multifunctional teams.
Some project management capability.
Documentation, Science background, GMP, 2-5 year of experience.
Experience with method/assay development and analytical methodology.
Strong Quality orientation with attention to detail required.
Good communication skills, both written and verbal, with all levels of the organization, including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution.
Ability to create and manage work plans and timelines and independently manage competing priorities with limited instruction.
Highly motivated individual with good interpersonal skills that have proven effective in managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external.
Language expertise- in addition to being fluent in English, working knowledge of one other international language (in particular German, Japanese, Mandarin or Russian) is a plus.

Education:
A BS/MS in Analytical Chemistry or related field with 5-10 years of relevant work experience is required.