Director – Pharmacokinetics; Regulated Bioanalytics – Exploratory Vaccines & Regulated Robotics – LIMS & Data Management
| Company | Merck |
|---|---|
| Location | North Wales, PA, USA, Ambler, PA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- B.A./B.S. in Biology, Chemistry, Biochemistry, Engineering, Data Sciences, Computer Science or a related discipline with at least 15 years, M.S. with at least 10 years, or Ph.D. with at least 8 years of related experience
- Extensive experience utilizing or implementing custom or commercial LIMS in a regulated bioanalytical laboratory
- Significant experience with software visualization programs
- Familiarity with computer control concepts to assist in troubleshooting and implementing computer-based lab automation and instrumentation
- Ability to lead, mentor, and inspire scientists at various levels; encourages curiosity in others and challenges the status quo to foster innovation
- Demonstrated ability for taking initiative, creativity, and innovation in problem solving
- Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment
- Experience in Agency inspections/audits
- Experience with regulatory submissions
- Experience working within a GLP, GMP, or other GxP laboratory
- Excellent oral and written communication skills
- Experience leading diverse teams and driving a collaborative and inclusive mindset
Responsibilities
- Provides leadership to individual contributors on LIMS & Data Management team
- Represents LIMS & Data Management in early/late vaccine development teams and influences data strategies together with stakeholders
- Provides oversight of development, testing, validation, and implementation of LIMS systems or related upgrades to meet the needs of various bioanalytical assays
- Provides oversight of strategy, development, and validation of IT solutions for visualization tools for the review of experimental data and for IT tools used to track material through automated systems
- Designs, assesses, and implements novel approaches and technology for data management
- Identifies opportunities for new internal and external collaborations, engages collaborators, identifies business needs and values, and proposes proper solutions
- Resolves complex technical, operational, and financial problems
- Reviews and approves data as needed
- Applies business and management expertise to set and achieve financial and operational objectives for the LIMS & Data Management team
- Influences others internally and externally, including senior leaders, internal customers, and external partners
- Develops relationships with key stakeholders, including science teams, IT, quality, and other partnering organizations to drive improved, quality operations
- Develops priorities and objectives for the LIMS & Data Management group to align with division scorecard
- Promotes our company’s scientific excellence and regulatory influence through leadership in the scientific community
Preferred Qualifications
- Strong external scientific reputation including publications, regulatory guidance documents, presentations at scientific meetings, membership on (or leading) cross-company working groups or consortia
- Experience working in a GLP bioanalytical laboratory
- Project management skills