Director R&D Analytical Lab Services

Job Title: Director, Analytical Lab Services

Department/Division: R&D Analytical Lab

Reports To: VP – R&D

Positions Supervised: Analytical Lab Services Manager

FLSA: Exempt

About LTS:

LTS Lohmann is a premier, global Contract Manufacturing and Development Organization (CDMO) and partner the pharma industry trusts most to deliver innovative oral, transdermal, and intradermal drug delivery systems. From concept to market, launch to lifecycle management, we deliver single source oral and transdermal drug delivery solutions that power partners’ market advantage. Every one of our 1,000 plus members of the LTS family, across three continents, is focused on utilizing our collective strength and innovation to explore new therapeutic opportunities, maximize partner value and improve patient outcomes.

We Care.

We Create.

We Deliver.

Job Summary:

As the Director, Analytical Lab Services you’re highly motivated to lead an analytical development group responsible for rapidly advancing analytical method development and method qualification for LTS’ innovative drug delivery programs. You’ll be accountable for method development/validation/transfer of the methods for use in quality control testing of GMP clinical trial and full production batches.

Duties/Responsibilities:

• Act as a to-go person for the Analytical Development team and demonstrate technical expertise on the development of analytical methods and phase-appropriate control strategies for API and DP.
• Lead day-to-day analytical activities to support the development and manufacturing of API and DP and participate in cross-functional PDM project team meetings.
• Author and review Quality sections and respond to queries from regulatory agencies.
• Prepare, review, and approve study protocols and reports.
• Apply high quality standards/ principles during the different stages of product development, including review of drug product & API characterization, raw material quality attributes, design of experiments, stability testing, analytical methods development & validation/optimization, and statistical evaluation of data.
• Compile and challenge project schedules with the project team, manage timelines through critical path analysis, monitor completion of key development tasks through milestone completion, quality gates, and stage gating processes
• Develop and maintain project plans for internal and external analytical resources, timelines, and budgets
• Develops robust and validatable analytical methods.
• Evaluates and implements advanced tools and technologies to improve speed, quality, and output of analytical development work.
• Creates high-performance teams, mentors staff, and provides a learning environment to the team.
• Acquires advanced technical knowledge from external sources and implements best practices within the team.
• Travel within the United States and internationally may be required.
• Engage directly with client technical and project management staff as needed to collaborate and drive projects to successful and timely completion.
• Ensure that Analytical Lab capabilities and equipment are fully capable of meeting department objectives.
• Plan and manage annual expense and capital budgets for Analytical Department

Experience, Education, & Preferred Abilities:

• Bachelor’s degree in Biochemistry, Biology, Biotechnology, or a closely related field.
• Master’s degree or Ph.D. in Biochemistry, Biology, Biotechnology, or a closely related field preferred
• 8-10 years of experience in leading analytical method development for GMP regulated products
• Knowledge and expertise with analytical instrumentation such as HPLC/UPLC, Mass Spectrometry, Dissolution, GC
• Experience of leading teams, managing staff with diverse skills sets and backgrounds, developing, coaching and mentoring technical staff, performing reviews and creating appropriate performance metrics.
• Strong critical thinking and problem-solving skills.
• Strong teamwork across departments and with discovery and research functions.
• Expertise in phase-appropriate small molecule analytical method development and validation
• Excellent written and verbal communication skills, organization, and planning skills and a high level of technical aptitude and creativity
• Ability to multi-task and thrive in a fast-paced innovative environment
• Excellent scientific and business communication skills (verbal, written, and presentation), strong. interpersonal/collaboration skills, and planning skills, as well as people management skills.