Associate Director, Liquid Handler Automation
Proclinical is currently recruiting for an Associate Director, Liquid Handler Automation with a pharmaceutical company located in Philadelphia, PA. Drives the automation and new technology efforts in Analytical Development. Leads team of scientists and engineers and partners with other technical staff within Analytical Development to onboard new instrumentation to deliver improved or new methods to Testing Operations. Serves as the resident expert in automation and provides guidance and direction to Analytical Development as well as cross functional automation teams. Ensures all new methods are compliant with current industry and regulatory standards. Oversees and manages collaborations and assay transfers to Testing Operations.
- Ensures user requirements for automation are clearly defined based upon existing methodology, when applicable, and new equipment is appropriately vetted prior to purchase.
- Builds and authors business case for automation. Partners with Finance to determine Return on Investment for equipment and presents to Management.
- Partners with Operations Specialist and vendor to procure and onboard instrument(s).
- Serve as owner of implementation of units.
- Programs methods, as needed, and oversees R&D studies to transfer manual methods to new instrumentation.
- Designs and authors bridging/comparability studies and oversees execution.
- Writes research and development reports and ensures data are reported clearly and accurately.
- Oversees assay transfers to Operations. Ensures clear project timelines and deliverables are set at the beginning of each project and communicates timelines and project progress to management routinely.
- May serve as trainer for inter- and intradepartmental staff when needed.
- Excels in method troubleshooting. Clearly communicates scientific knowledge internally and externally.
- Diagnose and troubleshoot equipment related issues. Partners with vendors to diagnose and correct mechanical issues.
- Champion and/or Lead projects related to Continuous Improvement of existing assays, processes and systems. Work cross-functionally with QA, Facilities, Metrology, Business Excellence, and Testing (Operations and Analytical Development) to support site-wide automation and innovation goals.
- Build, develop, coach and lead Automation and Innovation Team through supporting all aspects of automation and innovation initiatives.
- Assume responsibility for direct reports and team. Direct and lead team to stay on track to meet project deadlines. Communicate progress to manager regularly.
- Conducts regular staff meetings and one on one meetings with each direct report to provide appropriate team building and coaching.
- Assess team resourcing needs and communicates headcount justifications to manager.
- Assists senior management in Analytical Development with the departmental strategical planning and growth and success of their team.
- Serves as technical reviewer and LIMS tech manager, as needed. Drafts new test methods for automated assays when needed.
- Participates in client calls and face to face meetings as a subject matter expert, as needed.
- Completes all required training (i.e. safety, equipment etc.).
- Ability to work in a team environment and independently as required
- Maybe required to work Holidays and weekends
- Contributes to the overall operations and to the achievement of departmental goals
- Thorough understanding of Good Manufacturing Practices
- May be required to assist in other departments
Skills and Requirements:
- Bachelors' degree in Biological Sciences or science related field with 12 years of relevant automation experience or
- Masters' degree in Biological Sciences with 8 years of relevant automation experience or
- PhD in Biological Sciences with 5 years of relevant automation experience
- Experience introducing new automation and technology platforms in a GLP or GMP environment is required.
- Significant experience programing liquid handlers is required.
- Experience designing and conducting comparability studies between manual and automated methods is required.
- Experience implementing systems under GAMPs 4 and 5, 21 CFR Part 11, and other related regulations is required.
- Previous experience managing technical staff is required.
- Experience with advanced therapies is highly desirable.
- Proven troubleshooting skills.
- Ability to evaluate technical data and write complex technical documents.
- Ability to use judgment as dictated by complexity of situation.
- Ability to work under limited supervision and to handle problems of a difficult nature.
- Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
- Ability to lead a productive team, work effectively as part of a team, and to exhibit effective interpersonal skills.
- Ability to effectively manage staff and deliver clear instructions and feedback routinely and as part of the review process.
- Excellent Oral & Written communication skills
- Need to be able to read, write and understand English
- Proficient in Microsoft (Excel, Word, Outlook)
- Travel may infrequently be required.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.