Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Pre-formulation Scientist in Analytical Development in our San Diego, CA labs.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission.
Primary focus will be on enabling the transition of traditional synthetic molecules, Oligonucleotides and Lipid Nanoparticles (LNP) formulations from Discovery into Development, with a focus on physicochemical assessment and development of formulations to support non-GLP/GLP in vivo and early clinical development across a range of therapeutic areas. This will involve Cross functional interactions with Research Teams: Drug Safety, DMPK and close collaboration with Process Chemistry Development and Drug Product Development to achieve project goals.This position reports into the Analytical Development function in Pharmaceutical Sciences.
·Independently designs and executes detailed studies on new development candidates and platform technologies to elucidate fundamental physicochemical properties and behaviors that enable lead candidate selection and downstream CMC development.
·Responsible for significant or sole technical leadership within a project and provides theoretical/conceptual input across multiple projects within the department or Pharmaceutical Sciences Division
·Contributes to a cross-functional Pharmaceutical Sciences team responsible for overseeing API salt and polymorph selection and subsequent development activities
·Develops non-GLP, GLP and Phase 1 formulations based on the physical chemical properties of compounds or drug delivery systems and their route of delivery to support pre-clinical and clinical studies.
·May conduct biorelevant in vitro studies to assess potential in-vivo performance/impact of drug substance and drug product during development lifecycle
·Interfaces with individual Pharmaceutical Science colleagues and cross functional project teams to ensure that ongoing development activities are aligned with project timelines and strategy
·Represents functional area on cross functional teams communicating Pharmaceutics Research activities and milestones
·Participates on Discovery Teams and collaborates with Drug Safety and DMPK to evaluate the developability of molecules in late Lead Optimization.
·Collaborates with Drug Safety to transfer formulations to CRO’s for non-GLP and GLP toxicology studies
·Responsible for integrating scientific/technical efforts around cross functional issues
·Plans and implements resolutions to technical problems/issues
·Supports local and global initiatives which may include leading initiatives or work streams
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
Knowledge and Skills:
·Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems and determine causes and possible solutions.
·Preference may be given to applicants with hands on experience with analytical method development techniques using LC, GC, GCMS and LCMS along with troubleshooting skills for such methods, instrumentation, or software issues
·Someone who can recommend systems, processes, or changes within project scope to meet objectives and timelines
·Teamwork -- Ability to work well in highly cross functional team environment and across global line functions.
·Communication Skills -Able to expresses oneself clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates issues to supervisor; technical writing skills to support authorship of internal technical documents
·Organization – Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously
·Knowledge Sharing - Ability to capture organizational knowledge; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use
·Resource Management -Ability to manage one’s time within individual, departmental, and corporate goals, and timelines; management of internal and external resources (vendors)
·Technical - Proven knowledge in development of Oligonucleotides and/or Lipid Nanoparticles (LNP’s) required. Strong knowledge of physicochemical and preclinical formulation theory along with experience in multiple analytical techniques (DSC, TGA, HPLC, XRPD, Raman, PAT tools etc.) and proven ability to work in a lab setting. Experience in developing enabling formulations, such as SDD, nano-suspensions, lipidic formulations. Working knowledge of traditional synthetic small molecule development and in silico predictive tools/modeling is advantageous.
Education and Experience Required
- PhD degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science with 2+ years relevant experience, or
- MS degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science with 6+ years relevant experience, or
- BS degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science with 8+ years relevant experience
- Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events
Location: San Diego, CA - Hybrid
·May require approximately 5-10% travel.
Base Salary Range: $150,000 - $186,000Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.Locations
San Diego, CAWorker Type