PLS Senior Scientist

This is an onsite full-time Senior Scientist position located in San Diego, CA Monday - Friday, from 8:30 a.m. - 5:00 p.m.

SUMMARY

The Senior Scientist will lead the development and optimization of long-acting injectable formulations at Pace Analytical Life Sciences in San Diego CA with minimal supervision. This role requires a deep understanding of pharmaceutical sciences, drug delivery systems, and biopharmaceuticals such as peptides, proteins and antibodies. The ideal candidate will possess a proven track record of successful product development, a passion for advancing therapeutic solutions, and will leverage their network to support new business development opportunities. This role will provide feedback and guidance to clients regarding the analysis of materials, products and/or devices utilizing complex to specialized professional and technical knowledge of chemistry/biochemistry/formulation development or related equipment, testing, and procedures.

ESSENTIAL FUNCTIONS

• Serves as a lead to staff to include providing work direction, guidance, and training.
• Designs experimental procedures to define objectives and execution of long acting injectable formulation studies based on industry guidelines.
• Leads research and development projects, tracks progress to ensure on-time completion, within budget, and high-quality results.
• Provides advanced to expert analysis in support of various testing materials, products and/or devices utilizing various analytical instrumentation; follows Standard Operating Procedures and methods to perform testing.
• Develop validate and transfer analytical methods. Provide routine and non-routine analysis using instruments such as HPLC, GC, LC-MS, and FTIR, among others.
• Design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products.

• Design and conduct experiments to optimize drug release profiles and stability.

• Collaborate with cross-functional teams including regulatory affairs, clinical development, and manufacturing.

• Analyze and interpret data, and present findings to stakeholders.

• Provides advanced to expert review, analysis, interpretation, and documentation of testing results. Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.
• Provides training and guidance on analytical tests, methods, and instrumentation, as required. Provides training and guidance on analytical tests, methods, and instrumentation, as required.
• Provides advanced to expert analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change.
• Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.
• Assists with developing or participating in chemistry/biochemistry/formulation or cross functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management and/or clients.
• Ensure all activities adhere to SOP's, regulatory guidelines, GLP and GMP standards.
• Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
• Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.

QUALIFICATIONS

Education and Experience

• Bachelor's degree in chemistry/biochemistry, or a closely related field.
• Twelve (12) years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience. A Master's or Ph.D. degree is strongly preferred.

• Minimum of 8 years of experience in drug delivery or pharmaceutical development, with a focus on long-acting injectables.

• Demonstrated expertise in formulation development, analytical techniques, and biocompatibility assessment

Required Knowledge and Skills

Required Knowledge

• Expert in formulation development with small molecules and peptides, specifically around long-acting injectables and sustained release

• Lead client formulation development projects from concept to GLP readiness

• Demonstrated expertise in formulation development, analytical techniques, and biocompatibility assessment.
• Advanced to expert principles, practices, and techniques of chemistry/biochemistry and formulation development/
• Broad understanding of the administration and oversight of chemistry/biochemistry programs, policies, and procedures.
• Advanced to expert methods to resolve chemistry/biochemistry problems, questions, and concerns.
• Broad understanding of applicable chemistry/biochemistry laws, codes, and regulations.
• Understanding of broad testing tools, equipment, and calibration.
• Computer applications and systems related to the work.
• Principles and practices to serving as an effective project team member.
• Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
• Correct business English, including spelling, grammar, and punctuation.

Required Skills

• Performing advanced to expert professional-level chemistry/biochemistry duties in a variety of assigned areas.
• Overseeing and administering broad and varied chemistry/biochemistry/formulation functions.
• Ability to operate and train others in analytical instruments and manufacturing equipment.
• Training others in policies and procedures, and innovative practices related to the work.
• Serving as a leader in the design, development, and management of projects.
• Operating in both a team and individual contributor environment, as well as project leader.
• Interpreting, applying, and explaining applicable laws, codes, and regulations.
• Preparing advanced to expert functionals reports, correspondence, and other written materials.
• Using initiative and independent judgment within established department guidelines.
• Using tact, discretion, and prudence in working with those contacted in the course of the work.
• Performing effective oral presentations to large and small groups across functional peers and the department.
• Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.
• Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.

PHYSICAL/MENTAL REQUIREMENTS:

The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.

WORKING ENVIRONMENT:

Work is performed in a lab and office setting. Work is subject to chemicals, fumes, gases, noxious odors, and related items in a lab setting.

Pace Life Sciences

Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations.