Hikma Pharmaceuticals

Principal Scientist, QC Development – Life Cycle

Hikma Pharmaceuticals

full-time

Posted on:

Location Type: Office

Location: Columbus • Ohio • United States

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Job Level

Lead

About the role

  • Managing highly technical analytical projects in support of new products analysis, development and validation to facilitate a consistent and compliant approach.
  • Conducts analytical method development, testing and validation in support of regulatory submissions and new product launches.
  • Provides peer leadership, mentoring and decision-making for various laboratory studies in support of ANDA/NDA applications and/or application updates (validation, verification, equivalency, etc.).
  • Develops with little to no supervision and validates analytical procedures to meet SOPs, ICH, JP, EP, USP, EMEA, and FDA requirements; performs analytical transfers for multi-source and brand products internally and externally.
  • Organizes study data to assist/write technical reports.
  • Takes the lead on assigned highly technical projects with little to no supervision to facilitate analytical method development, testing, validation and project support for alternative API and business development projects.
  • Using project planning tools, identifies, offers, and implements contingency plans to prevent and overcome analytical issues and perform analytical procedure troubleshooting with little to no supervision.
  • Performs qualitative, quantitative, developmental, chemical and physical testing for highly technical projects as specified by compendia (USP, JP, BP), regulatory authority (FDA & ICH) for starting materials, packaging components, intermediates and finished products.
  • Follows work instructions, SOPs, company practices and regulatory guidances/regulations.
  • Documents analytical activities and results accurately, in a timely manner and right-first time.
  • Reviews and checks analytical data generated by peers and maintains integrity of data.
  • Supports activities to maintain the laboratory status of compliance to FDA/regulatory standards.
  • Proactively participates in activities in support of process changes (e.g. processes, procedures, etc...).
  • Suggests and leads process improvements to refine current systems and improve efficiency.
  • Mentors peers in method development, validation, troubleshooting, instrumentation, laboratory practices, and processes.
  • Conducts training on selected topics of interest for the department.
  • Communicates effectively with peers, supervisor, management and internal/external customers about project status.
  • Monitors project status and proactively communicate to supervisor potential delays and challenges, along with a path forward.
  • Participates and represents the department in cross-functional teams.

Requirements

  • B.S degree and Ten (10) years of laboratory experience in a pharmaceutical or highly regulated environment.
  • M.S. degree and Six (6) years of laboratory experience in a pharmaceutical or highly regulated environment.
  • For Ph.D. degree and Five (5) years of laboratory experience in a pharmaceutical or highly regulated environment.
  • Must possess specialized knowledge of ICH and FDA guidances, technology transfer requirements, method development and validation, technical writing and submission documents, and instrumentation with a GxP and regulatory emphasis.
  • Knowledge of Quality/GMP relevant regulations, ICH, and FDA guidances, method validation principles, and method development.
  • Knowledge in chromatographic applications such as HPLC, GC, and UV-Vis, as well as dissolution, laser diffraction particle sizing, and titrations.
  • Knowledge in support of NDA and ANDA regulatory submissions for multiple dosage forms.
  • Must possess excellent written and verbal communication skills, technical writing, organizational, leadership and presentation skills.
  • Demonstrated ability to develop and manage multiple short and long-term projects from start to completion.
  • Ability to plan short- and long-term capacity models to support project execution (preferably in an application such as Microsoft Project)
  • Experience with data acquisition software.
Benefits
  • Annual performance bonus, commission, and share potential
  • Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay.
  • Hikma will match 100% of the first 6% of eligible pay that you contribute
  • A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date).
  • Additional days granted upon reaching work milestone anniversaries
  • 3 personal days (prorated based on hire date)
  • 11 company paid holidays
  • Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
  • Employee discount program
  • Wellbeing rewards program
  • Safety and Quality is a top organizational priority
  • Career advancement and growth opportunities
  • Tuition reimbursement
  • Paid maternity and parental leave
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
analytical method developmenttesting and validationmethod validationchromatographic applicationsHPLCGCUV-Visdissolutionlaser diffraction particle sizingtitrations
Soft Skills
peer leadershipmentoringdecision-makingtechnical writingorganizational skillscommunication skillspresentation skillsproject managementprocess improvementtroubleshooting