What are the responsibilities and job description for the Associate Director of Analytical Development, Cleaning Validation position at Serán BioScience?
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.
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 processes
Represents the site in client interactions for all questions related to analytical cleaning and swab recovery methods
Represents the site in audits for all questions related to analytical cleaning and swab recovery methods
Provides general analytical chemistry technical support throughout Serán, as needed
Supervises cleaning validation team, acting as an advisor to team members when determining how to meet schedules or resolve technical problems
Demonstrates knowledge performing analyses used to assess the swab recovery of active pharmaceutical ingredients
Supports laboratory special projects, as appropriate
Ensure 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 necessary
Manages workplans & resources across multiple projects
Effectively communicates with clients, Project Manager, and internal teams on various projects, schedules, and resolutions
Fluently applies fundamental scientific principles to solve problems and guide decisions
Independently interfaces with project management & other departments to manage timelines and workplans
Appropriately interprets and communicates technical information
Stay current with industry practices and regulatory requirements
Identifies opportunities for improvement and proposes solutions
Provides data to Director and / or Executives to support capital equipment purchases and / or facility changes
Reviews technical protocols, executed validations, summary reports, and presentations for completeness and accuracy
Mentors / manages junior scientists, as needed
Adheres to consistent and predictable in-person attendance
Responsibilities 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 company
Demonstrated ability to collaborate and work in cross-functional teams
Strong organizational skills and attention to detail
Strong time management skills with a proven ability to meet deadlines
Strong analytical and problem-solving skills
Ability to prioritize tasks and to keep leadership apprised of performance to timelines
Multitasks and adjusts priorities in a fast-paced environment, while maintaining focus and managing disruption an / or unexpected needs
Accepts feedback from a variety of sources and constructively manages conflict
Ability to prioritize tasks and to delegate them when appropriate
Proficient 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 experience
Minimum 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 computer
Prolonged periods of sitting or standing in laboratory environment
Must be able to lift up to 15 pounds at times
Compensation 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.
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