Research Scientist specializing in Generative AI at Adobe. Conducting innovative research and technology development for Adobe products.
About the role
- Principal Scientist managing analytical projects for Hikma Pharmaceuticals focusing on compliance and validation in pharmaceutical development. Overseeing technical projects and mentoring team members.
Responsibilities
- 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
Job title
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