Principal Scientist, QC Development & Life Cycle

Hikma Pharmaceuticals USA Inc.•Columbus, OH

17d

About The Position

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them. We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Scientist IV, QC Development & Lifecycle to join our team. In this role, you will be responsible for Managing highly technical analytical projects in support of new products analysis, development and validation in order 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.).

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 a 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.
Possess excellent written and verbal communication skills, technical writing, organizational, leadership and presentation skills.
The candidate must have the ability to work with minimal supervision using scientific judgment and professional competency.
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.

Nice To Haves

M.S. or Ph.D. degree in a scientific discipline such as chemistry, pharmacy.
In-depth knowledge of the critical functions/variables of the analytical techniques, and proven ability to troubleshoot analytical procedures.
In depth knowledge of current FDA/ICH guidances, national pharmacopoeias, cGMP regulations and analytical regulatory requirements for ANDA/NDA submissions.
Experience working in a team environment approach to accomplish tasks assigned using proven coaching skills.
Experience working on multiple tasks in a fast pace environment.
Project management and organizational skills are required.
Experience in mass spectrometry applications.
Experience in nasal spray dosage forms, including actuation performance tests such as pump delivery, spray content uniformity, spray pattern, plume geometry, actuation force, etc.

Responsibilities

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 trouble shooting 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 trainings 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.

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