19 days old

Senior Scientist - CMC Analytical Development

Takeda California, Inc.
San Diego, CA 92101
  • Job Code
    R0014376

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Scientist - CMC Analytical Developmentin ourSan Diegooffice.

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.

POSITION OBJECTIVES:

Takeda California is searching for an experienced, highly motivated pre-formulation/formulation development scientist to work in a dynamic, cross functional, and fast paced environment in support of the discovery and development of novel medicines targeting indications in neurosciences and gastrointestinal diseases. The ideal candidate will be responsible for leading such pre-formulation/formulation and drug product development activities with emphasis on small molecule oral drug product formulations supporting pre-clinical toxicology studies, IND filings, and first-in-human clinical trials. This includes the design and conducting of laboratory experimentation, the independent analysis and interpretation of related data, and providing risk-adjusted recommendations to cross-functional project teams.

ACCOUNTABILITIES/RESPONSIBILITIES:

  • Work collaboratively with discovery project teams, medicinal chemistry, DMPK, toxicology, pharmacology and clinical development to develop and deliver appropriate drug products to enable preclinical studies and support clinical studies
  • Represent the functional line on CMC team and ensure the alignment of functional line deliverables with project objectives
  • Act as a subject matter expert, lead drug product development activities from preclinical stage to Phase 1 clinical studies
  • Guide CROs to design formulations and conduct the related development appropriate for the stage of development from pre-clinical stage through Phase 1
  • Lead internal and external activities to identify and understand the development form and physicochemical properties (salts, polymorphism, co-crystal, solubility, and stability, etc.)
  • Serve as a scientific/technical leader in support of functional line strategy and priorities
  • Establish/manage aggressive timelines (i.e. via Gantt charts), identify key risks and critical path activities, propose pertinent risk mitigation strategies
  • Manage external CROs/CDMOs to prepare drug product intermediates, e.g. SDD, and drug products under GLP and cGMP regulation to support toxicology studies and clinical trials
  • Authoring of formulation development reports and drug product sections in regulatory filings with health authorities (IND, IMPD, etc.)

EDUCATION, EXPERIENCE AND SKILLS:

Education and Experience Requirements:

  • PhD, in pharmaceuticals, chemistry, material science, chemical engineering, biomedical engineering, or related discipline with at least 5 years of relevant industry experience preferred; MS in pharmaceuticals, chemistry, material science, chemical engineering, biomedical engineering, or related discipline with at least 15 years of relevant industry experience
  • Profound and comprehensive scientific knowledge in pre-formulation and formulation development
  • Ability to independently and effectively manage work conducted at CROs and CDMOs
  • A proven track record of successful development of oral dosage formulations
  • Expert in the design and development of drug products as extemporaneous preparation for clinical studies
  • Experience to draft drug product sections of INDs and IMPDs
  • Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP regulations
  • Basic understanding of Microsoft Project
  • Effective oral and written communication skills
  • A desire to be part of a highly innovative company, helping patients with serious diseases of unmet medical need
  • Ability to travel both internationally and domestically, driven by project need (approximately 10-15%)

Preferred Qualifications:

  • Ability to develop and implement control strategies for drug product development and manufacturing
  • Experience with controlled release formulation development and manufacturing
  • Experience with small molecule oral and injectable formulation development and manufacturing
  • Development of dissolution enhancing formulations (SDD, micro or nano particles, etc.) for Biopharmaceutics Classification System (BCS) Class II compounds, and extemporaneous formulation preparation for FIH clinical trials
  • Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP regulations
  • Ability and track record of successfully leading CMC function and representing CMC function in cross-functional teams to progress projects
  • Ability to navigate and be successful in a fast-paced, highly-matrixed work environment

TRAVEL REQUIREMENTS:

  • 10-15%

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

    Empowering Our People to Shine

    Discover more at takedajobs.com

    No Phone Calls or Recruiters Please.

#LI-KS1

Locations

San Diego, CA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2019-11-25 Expires: 2019-12-24
Sponsored by:
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Sponsored by:
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Senior Scientist - CMC Analytical Development

Takeda California, Inc.
San Diego, CA 92101

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