4159 Technical Scientist Project Manager

Summary:
The Contract Technical Project Manager will be a member of the Analytical Chemistry Validation and Method Transfer Department.
The Analytical Chemistry Validation and Method Transfer Department 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.

Duties:
Project management activities to support partners with project leaders and team members to ensure proper and timely execution of all aspects of the clinical analytical method life cycle across the company’s clinical product portfolio and testing sites (including CMOs and partners).
Evaluation of corporate and regulatory policies and coordination of activities for implementation of these policies.
Support authoring the contents of Analytical Method Validation life cycle documentation (including master plans, protocols, test methods, and reports).
Creates a project validation plan (i.e., timelines and resources) and provides status updates to management.
Utilize statistical tools for evaluation of method validation and trending data.
Additionally, the candidate is expected to identify, evaluate, and implement continuous business process improvements. Excellent communication and presentation skills are essential.

Qualifications:
Candidates should have a Ph.D. in Analytical Chemistry or other scientific fields with demonstrated experience in Quality Control laboratories for biotechnology products. B.A. or B.S. degree in analytical chemistry or other scientific field with 5-10 years’ experience in the areas of method development, validation and transfer and product management.
Good understanding of project management skills and tools.
Good knowledge in analytical chemistry across a wide range of technologies eg. HPLC, CE, etc.
Proficient knowledge and experience of QC assay development and validation, and cGMP.
Understanding of Quality systems.
Excellent 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 individuals 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.

The hiring range for this position is $65-$75 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, Sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.