Methods Development Scientist

Company: Hologic, Inc.
Location: San Diego
Posted on: March 12, 2025

Job Description:

Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.We are seeking a highly motivated and experienced Scientist with a strong background in Analytical Method Development to join our dynamic team here in our Diagnostics division. The successful candidate will be responsible for leading the development, validation, and transfer activities of analytical methods for raw materials and oligonucleotides. The candidate will work with other senior level scientists to perform troubleshooting, failure investigations and/or method optimization and ensure that appropriate documentations are accurately completed.This is a fully onsite position in San Diego, CA.Key Responsibilities:

• Independently develops, troubleshoots, and optimizes methods with minimal supervision.
• Independently troubleshoots and qualifies analytical equipment.
• Provides technical leadership and training to junior development associates and QC analysts.
• Leads & designs method/equipment development and validations.
• Independently drives priorities and completes resource capacity planning as an independent contributor.
• Manages independent deliverables in the context of project timelines.
• Independently forms cross-functional relationships to achieve deliverables.
• Leads analytical specification development or change activities.
• Designs analytical methods, equipment qualification plans, & validations.
• Proposes and leads experimental test plans for analytical investigations.
• Designs and leads raw material qualifications.
• Leads quality investigations and documentation (e.g. NCEs, CAPAs, Investigation Reports).
• Engages with R&D for analytical method development and transfer activities. Reviews and contributes to analytical R&D transfer documents for subcomponents.
• Possesses knowledge of statistical methods and tools (e.g. JMP).
• Supports technical (method/product) and business improvement projects.
• Developing deeper knowledge of regulatory requirements for analytical methods (e.g. USP, FDA, ICH, ISO).
• Supports review of transfer documents with components for analytical testing.
• Authors and presents technical updates with minimal guidance.
• Authors product testing documentation with supervision.
• Authors analytical method SOPs with supervision.Required Education and Experience:
  • PhD in Chemistry, Biology, Biochemistry, Chemical Engineering, or related science, with at least 4 years of relevant industry experience.
  • MSc or BSc in Chemistry, Biology, Biochemistry, Chemical Engineering, or related science, with at least 5 - 7 years of relevant industry experience.
  • Previous management experience (highly desired).
  • Strong experience with product and/or method development and validations/qualifications (required).
  • Strong knowledge of analytical techniques and instrumentation.
  • Oral communication skills.
  • Strong interpersonal skills.
  • Strong technical writing and presenting experience.
  • Advanced technical and problem-solving skills.
  • Strong independence and multitasking skills.
  • Advanced understanding of cGMP/GLP, USP, FDA and ICH guidelines.The annualized base salary range for this role is $112,000 to $175,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.Why Hologic?We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.If you have the right skills and experience, apply today!
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Keywords: Hologic, Inc., San Diego , Methods Development Scientist, Other , San Diego, California