Sr. Scientist

RXinsider LTD.; Cherry Hill Township (NJ); On-site; USD 67,000 - 134,000; Full time

Benefits offered by this job

Annual bonus

401(k) matching

PTO 20 days

Personal days

11 holidays

Health, dental, vision benefits

Tuition reimbursement

Parental leave

Employee discount

Job summary

Hikma Pharmaceuticals USA Inc. in Cherry Hill, NJ seeks a Senior Scientist to support parenteral manufacturing through RMQ/qualification and validation of materials and processes. You will handle protocols, reports, investigations, and process improvements, with potential involvement in FDA audits.

Mentoring staff and leading complex projects are expected. Education requires a BS in Engineering or Pharmaceutical Sciences with 5+ years (or 4+ with an advanced degree) of related experience.

Qualifications

• Ability to communicate effectively at all levels in verbal and written form.
• Proficient in Word, Excel, Visio and in technical writing.
• Familiar with FDA guidelines for JOS and RMQ documents.
• Proficient in writing Change Controls, CAPAs, Investigations, Protocols, Reports and Deviations.
• Able to identify process optimization opportunities and work independently or in teams.
• Willingness to walk long distances, lift 10–40 lbs, and work varying shifts.

Responsibilities

• Applies thorough understanding of cGMP, SOPs, project procedures and management.
• Performs RMQ/Qualification studies for API, excipients, and components.
• Leads complex projects, prioritizes tasks and manages budget/time constraints.
• Writes/reviews RMQ protocols, sampling reports, and change controls.
• Provides mentoring and leadership to less experienced staff.

Skills

Communication

Technical writing

Project management

Problem solving

Autonomy

Team collaboration

Education

BS in Engineering/Pharmaceutical Sciences

Tools

Microsoft Word

Excel

Visio

Job description

Job Title: Senior Scientist

Location: Cherry Hill NJ

Job Type: Fulltime

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.

Summary: This position supports the parenteral pharmaceutical manufacturing facility through the qualification and/or validation of raw materials, components and manufacturing processes. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of manufacturing challenges are conducted, and process improvements are evaluated/ implemented. Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA, MHRA, and client/customer compliance audits.

Essential Duties and Responsibilities:

• Applies thorough understanding of cGMP, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
• Performs a variety of projects/studies in areas that include Raw Material Qualification (API and Excipients), Components Qualification (Primary & Secondary Components), as well as projects/studies to support implementation / filling.
• Handles projects that are more complex and broader in scope, such projects require team leadership, task prioritization, and management of budget and/or time constraints. Must demonstrate competent and effective planning, coordination, and organizational skills.
• Writes/Reviews RMQ / Sampling protocols, reports, Change Controls. Conducts Studies/Executes protocols.
• Provides mentoring and leadership to less experienced staff.

Qualifications:

• Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
• Proficient in Microsoft Word and Excel, Visio. Proficient in technical writing.
• Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in various disciplines including RMQ stream.
• Knowledgeable of FDA guidelines for Justification of Specification (JOS) and RMQ documents.
• Proficient in writing Change Controls, CAPAs, Investigations, Protocols, Reports and Deviations.
• Must be able to identify opportunities for optimization of processes within the department or the plant.
• Ability to work independently or in teams.
• Ability to walk some distance 1-3 miles, stand for 3-6 hours and lift 10 - 40 lbs. during the course of a work day as required.
• Ability to work any shift (1st, 2nd, or 3rd) and any day of the week (7 days) as duties require.

Education And/or Experience:

• BS preferably in the Engineering/Pharmaceutical Sciences (other degrees accepted provided the individual has relevant equipment validation experience) having a minimum of 5+ years related experience or 4+ years related experience w/ an advanced degree.

Compensation:

Base Salary: $66,600 to $133,750 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 3% 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.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

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.