Sr. Specialist, Data Review - R&D

Hikma Pharmaceuticals; Cherry Hill Township (NJ); Sur place; USD 66 000 - 134 000; Plein temps

Avantages offerts par ce poste

Annual bonus

401(k) with company match

PTO 20 days

Personal days

11 company paid holidays

Health, dental, vision

Life insurance

Employee discount

Wellbeing rewards

Tuition reimbursement

Parental leave

Résumé du poste

Hikma Pharmaceuticals USA Inc. in Cherry Hill, NJ, seeks a Sr. Specialist, Data Review – R&D Injectables to lead the critical review of pre-submission data for regulatory filings. You will ensure Data Integrity, Reliability, Accuracy, and Traceability of submitted data under cGMP and SOP guidelines.

The role requires expert knowledge of FDA/ICH guidelines, AR&D data, and collaboration with scientific staff to resolve deviations and ensure timely, compliant submissions.

Qualifications

• Bachelor’s degree in chemistry or closely related field with 5+ years of FDA regulated cGMP analytical development experience.
• Master’s degree in chemistry or closely related field with 3+ years of FDA regulated cGMP analytical development experience.
• Ph.D. in chemistry or closely related field with 2+ years of FDA regulated cGMP analytical development experience.
• Knowledge of pharmaceutical cGMP requirements, ICH/US FDA guidelines, and analytical method validation.
• Knowledge of pharmaceutical analytical technologies.
• Proficiency in LIMS, Empower 3 CDS and Quality Management software packages.
• Strong communication skills and ability to manage multiple projects.

Responsabilités

• Ensures cGMP and good documentation procedure during the review process.
• Audits regulatory pre-submission documents from AR&D and quality.
• Performs AR&D technical, scientific, and compliance review of data for regulated studies.
• Identifies deviations, OOS and OOT in AR&D data.
• Issues AR&D review observations and coordinates with scientific staff to ensure data integrity.
• Informs the manager immediately of any critical data integrity issues.
• Completes audit tasks within the specified timeframe without compromising quality.
• Performs additional responsibilities as assigned by the manager.

Connaissances

cGMP compliance

Analytical data review

Regulatory knowledge (FDA/ICH)

Data integrity

Project/workload management

Communication skills

Microsoft Office proficiency

Formation

Bachelor’s degree in chemistry or closely related field

Master’s degree in chemistry or closely related field

Ph.D. in chemistry or closely related field

Outils

LIMS

Empower 3 CDS

Quality Management software

Description du poste

Sr. Specialist, Data Review – R&D Injectables

Location: Cherry Hill, NJ

Job Type: Full-time

About Us

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 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 global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

Description

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 Sr. Specialist, Data Review – R&D Injectables.

In this role, you will be responsible for and accountable for the critical review of pre-submission raw data and reports ready for regulatory submission to the US FDA.

Responsibilities include the review of assigned pre-submission data and reports by using department SOPs and analytical methods to ensure Data Integrity, Reliability, Accuracy, and Traceability of any submitted data.

Key Responsibilities

• Ensures compliance with cGMP and good documentation procedure during the review process.
• Audits regulatory pre-submission documents from the Analytical Research and Development (AR&D) and quality.
• Perform AR&D technical, scientific, and compliance review of data and documentation generated by the AR&D group in support of regulated studies.
• Identify deviations, OOS and OOT associated with AR&D data as applicable.
• Issue AR&D review observations and work closely with the scientific staff to ensure data integrity.
• Informs the manager immediately of any critical data integrity issues or data irregularity.
• Completes the audit tasks within the specified timeframe without compromising the quality of the audit.
• Performs any other responsibilities which are required as assigned by the manager.

Qualifications

• Bachelor’s degree in chemistry or closely related field and at least 5 years of FDA regulated cGMP analytical development or related laboratory experience, OR
• Master’s degree in chemistry or closely related field with 3 years of FDA regulated cGMP analytical development or related laboratory experience, OR
• Ph.D. in chemistry or closely related field and 2 years of FDA regulated cGMP analytical development or related laboratory experience.
• Knowledge in pharmaceutical cGMP requirements, ICH/US FDA guidelines, Laboratory test procedures, raw material analyses, method validation guidelines, analytical method transfers, finished products and stability testing procedures, method validation protocols/reports, COAs, product development reports, and Quality overall summaries.
• Knowledge in pharmaceutical analytical technologies.
• Proficiency in LIMS, Empower 3 CDS and Quality Management software packages.
• Ability to monitor, coordinate and prioritize work in an effective and efficient manner, with capacity to manage simultaneous projects within a set timeline; ability to continuously make an assessment of the workload and suggest any support required on need basis.
• Demonstrates excellent interpersonal communication skills: verbal, written and presentation skills.
• Expert computer skills with the ability to enter data into and retrieve information from various software programs such as Microsoft Office Suite programs Word, Excel, PowerPoint, and Outlook.

Compensation

Base Salary: $66,600.00 to $133,750.00 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

What We Offer*:

• 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
• Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Equal Opportunity Employer

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.