For the safety of our employees and communities in response to COVID-19, Acadia has implemented a temporary work from home policy. As a part of this shift, we have migrated all interviews to virtual interviewing via phone and video.
Responsible for oversight of the outsourced analytical development activities associated with the method development, validation, and technology transfer of drug product. Manages multiple contract service providers (CSPs) to deliver comprehensive, consistent, and compliant analytical results.
M.S. in Chemistry or related field. Ph.D. preferred. An equivalent combination of relevant education and applicable job experience may be considered. A minimum of 7 years' experience in progressively responsible roles with a focus on analytical development techniques for finished drug products with 3 years' in a leadership role required.
Experience authoring technical reports and CMC sections for regulatory filings. Related experience should include hands on experience in at least one of the following analytical chemistry techniques - chromatography, dissolution and/or spectroscopic techniques. Experience with oversight management of CSP analytical laboratory preferred.
Provides direction to and review of, managers, supervisors, or employees in a segment of a functional area and/or manages segment to achieve goals in accordance with established policies, meet schedules and resolve problems. Develops, modifies, and implements policies that affect immediate operations and may also affect overall functional area. Works on abstract problems that may cross functional areas. Identifies and evaluates fundamental issues for functional area through assessment of intangible variables. Contributes to the planning of, and implements, department budget. Regularly interacts with senior management and executives on matters concerning functional area, division and/or customers. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations. Erroneous decisions will have a serious impact on the overall success of functional area and may impact overall company operations.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.
Acadia is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity