Serán BioScience is looking for an experienced leader to fill the role of Associate Director of Analytical Development, Cleaning Validation. This role will provide technical support and leadership for cleaning validation throughout the Company. Responsibilities include being the subject matter expert and technical resource in cleaning validation and swab recovery methods throughout laboratory and manufacturing environments. Situated within Serán's Quality Organization, this position will lead a small team in the development and growth of a cleaning validation program with the support of the Analytical Development department.
\n Supervisory Responsibilities Provides leadership to the Cleaning Validation Program Oversees workflow of the Cleaning Validation teams Develops personnel to ensure functionality across teams, high performance, and talent retention Integrates with the Quality Leadership Team to develop personnel and organizational effectiveness Duties and Responsibilities Provides technical expertise and support (SME) in laboratory HPLC cleaning validations and swab recovery processesRepresents the site in client interactions for all questions related to analytical cleaning and swab recovery methodsRepresents the site in audits for all questions related to analytical cleaning and swab recovery methodsProvides general analytical chemistry technical support throughout Serán, as neededSupervises cleaning validation team, acting as an advisor to team members when determining how to meet schedules or resolve technical problemsDemonstrates knowledge performing analyses used to assess the swab recovery of active pharmaceutical ingredientsSupports laboratory special projects, as appropriateEnsure that cleaning validation protocols and reports meet regulatory standards and support product quality and safety Works with larger, internal cleaning verification team to optimize and adjust program as necessaryManages workplans & resources across multiple projectsEffectively communicates with clients, Project Manager, and internal teams on various projects, schedules, and resolutionsFluently applies fundamental scientific principles to solve problems and guide decisionsIndependently interfaces with project management & other departments to manage timelines and workplansAppropriately interprets and communicates technical informationStay current with industry practices and regulatory requirementsIdentifies opportunities for improvement and proposes solutionsProvides data to Director and/or Executives to support capital equipment purchases and/or facility changesReviews technical protocols, executed validations, summary reports, and presentations for completeness and accuracyMentors/manages junior scientists, as neededAdheres to consistent and predictable in-person attendanceResponsibilities may increase in scope to align with company initiatives? Performs other related duties as assigned. Required Skills and Abilities Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the companyDemonstrated ability to collaborate and work in cross-functional teamsStrong organizational skills and attention to detailStrong time management skills with a proven ability to meet deadlinesStrong analytical and problem-solving skillsAbility to prioritize tasks and to keep leadership apprised of performance to timelinesMultitasks and adjusts priorities in a fast-paced environment, while maintaining focus and managing disruption an/or unexpected needsAccepts feedback from a variety of sources and constructively manages conflictAbility to prioritize tasks and to delegate them when appropriateProficient with Microsoft Office Suite or related software Education and Experience BS in Chemistry or equivalent plus 1 year of relevant experience; MS in Chemistry or equivalent plus 7 years relevant experience; PhD in Chemistry or equivalent plus 5 years relevant experienceMinimum of 3 years of GMP experience, five years of GMP experience preferred Experience in both clinical and commercial manufacturing environments Physical Requirements Prolonged periods of sitting or standing at a desk and working on a computerProlonged periods of sitting or standing in laboratory environmentMust be able to lift up to 15 pounds at times
\nCompensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees' wellbeing and pet insurance.