Inhalation Scientist, Analytical R&D

RXinsider LTD.; Piscataway Township (NJ); Hybrid; USD 80,000 - 90,000; Full time

Benefits offered by this job

Bonus potential

401(k) matching

Health benefits

Job summary

Amneal is seeking a mid-level Scientist-2 to support analytical development for oral dosage forms. The role involves method qualification/validation, analysis of APIs, excipients, and finished dosage forms, and maintaining analytical equipment in a cGMP environment.

The candidate should have 3+ years pharma experience with a Bachelor's degree or 1+ year with a Master's, plus experience with HPLC, GC, TLC, MS, and SOP writing. Strong communication and teamwork skills are required.

Qualifications

• Bachelor's degree in Chemistry or related science required.
• 3+ years of pharmaceutical experience with Bachelor's degree.
• 1+ year of pharma experience with Master's degree.
• Experience in cGMP laboratory testing is preferred.

Responsibilities

• Performs analysis and release of APIs, excipients, in-process materials, and finished drug products in support of formulation development.
• Develops and validates analytical methods for qualification and release testing.
• Provides timely responses to internal and external inquiries.
• Ensures deadlines and compliance with regulatory standards.
• Evaluates and implements new analytical technologies and instrumentation.
• Assists with training other members of the analytical development team.

Skills

Analytical techniques

Written communication

Organizational skills

Microsoft Office

Team player

Creative problem solving

Education

Bachelor's degree in Chemistry

Master's degree in Chemistry

Tools

HPLC

GC

TLC

MS

SOP writing

Job description

Job Description

The Scientist-2 is a mid-level analytical scientist opportunity supporting the analytical development of pharmaceutical oral dosage form. The individual in this capacity performs analytical methods qualifications/validations, analyzes active pharmaceutical ingredients, excipients, and finished dosage forms using appropriate analytical methods and maintains/qualifies analytical equipment.

Essential Functions

• Performs analysis and release of active pharmaceutical ingredients, excipients, in-process materials, and finished drug products to support the formulation development team, maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs.
• Develops and optimizes new and existing analytical methods for qualification and release testing of products. Develops stability indicating methods and performs methods validation.
• Provides timely responses to all internal and external inquiries.
• Ensures deadlines are met for product development schedules, and checks that technical and compliance requirements are met.
• Evaluates, recommends, and implements new analytical technologies and instrumentation for testing.
• Assists with training other members of the analytical development team.

Additional Responsibilities

• Stays abreast of new developments in analytical technologies. Contributes to improvement in laboratory operations to increase efficiency and GMP compliance.

Education

• Bachelors Degree (BA/BS) Chemistry or related science - Required
• Master Degree (MS/MA) Chemistry or related science - Preferred

Experience

• 3 years or more in pharmaceutical experience (with Bachelor's Degree)
• 1 year or more in pharmaceutical experience (with Master's Degree)

Skills

• Enthusiasm and dedication to learn and adopt new analytical techniques. - Intermediate
• Written and verbal communication and presentation skills. - Intermediate
• Ability to set priorities and to follow through on commitments utilizing organizational skills. - Intermediate
• Microsoft Office and ability to learn additional software/programs as needed. - Intermediate
• Meet deadlines under pressure. - Intermediate
• Able to work in a team environment. - Intermediate
• Creativity to solve technical and compliance problems. - Intermediate

Specialized Knowledge

• Broad knowledge of modern analytical equipment and techniques.
• Extensive experience in cGMP laboratory testing. Hands-on experience with HPLC, GC, TLC, and MS.
• Methods development experience.
• Experience writing the standard operating procedures (SOPs) and test methods.

The base salary for this position ranges from $80,000 to $90,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location, and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.

About Us

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.