Sr. QC Chemist

Sun Pharmaceutical Industries Limited; New Brunswick (NJ); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a seasoned analytical chemist to join their dynamic team. This role involves performing critical analytical testing on drug substances and products, ensuring compliance with GMP, ICH, and FDA guidelines. You will leverage your extensive experience with advanced analytical instrumentation and contribute to the preparation of submission documents. The company is committed to fostering a culture of innovation and integrity, providing a supportive environment that values professional growth and collaboration. If you are passionate about advancing healthcare and have a strong background in analytical chemistry, this opportunity is perfect for you.

Benefits

Medical Benefits

Dental Benefits

Vision Benefits

Health Savings Account

Flexible Spending Account

Short Term Disability Benefits

Long Term Disability Benefits

401k Company Match

Wellness Programs

Corporate Discounts

Qualifications

• 10+ years in pharmaceutical analytical lab with expertise in instrumentation.
• BS in Chemistry required; MS preferred for advanced roles.

Responsibilities

• Perform analytical testing for drug substances and products.
• Compile ANDA submission documents and support lab investigations.

Skills

Analytical Testing

Wet Chemistry Techniques

Communication Skills

Project Management

Problem Solving

Education

Bachelor's Degree in Chemistry

Master's Degree in Chemistry

Tools

HPLC

UPLC

GC

UV/VIS Spectrophotometer

FTIR

Dissolution Apparatus

Particle Size Analyzer

Microsoft Office (Excel)

Job description

COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!

• Medical, Dental, Vision Benefits
• Health Savings Account (HSA), Flexible Spending Account (FSA)
• Prescription Drug Coverage
• Telehealth and Behavior Health Services
• Income Protection – Short Term and Long Term Disability Benefits
• Retirement Benefits - 401k Company Match on Day One (100% vesting immediately)
• Group Life Insurance
• Wellness Programs
• Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods!

Sun Pharma Vision: Reaching People And Touching Lives Globally As A Leading Provider Of Valued Medicines

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility. Integrity. Passion. Innovation. It represents our promise to all stakeholders including patients, physicians, and employees.

Our Code of Conduct

Our Global Code of Conduct governs every aspect of our operations. Sun Pharma is a family of thousands of people, working across many countries, speaking multiple languages, and all united, with one common purpose: to make good health accessible and affordable to local communities and society at large. Through active fieldwork, dedicated research teams, and in recognition of the efforts who work behind the scenes to combat illness and disease, the Sun Pharmaceutical Group helps as many people as possible, to secure their right to good health. The way we work every day is important to us.

DOWNLOAD OUR CODE OF CONDUCT

Perform analytical testing for drug substances and various drug products such as tablets and capsules. Analyze exhibit batches, process validation batches, related stability testing. Perform method transfer and validation. Support lab investigation. Compile ANDA submission documents.

• Performs routine analytical tests of pharmaceutical raw materials, in-process samples, blends, finished products, and stability samples using instrumentation such as HPLC, UPLC, GC, UV/VIS, FTIR, dissolution apparatus, particle size analyzer, etc.
• Responsible for the timely execution of lab analysis and related documentation.
• Concurrent documentation of all the raw data, observations in the worksheets/templates/notebooks.
• Compile the analytical data and notify the results to supervisor.
• Perform QC testing of exhibit batches.
• Perform the testing of process validation/characterization batches and stability samples.
• Compile the data for ANDA submission and provide to RA/ODR.
• Perform the tracking and trending of lab data.
• Perform training of junior chemist.
• Support Manager for daily laboratory operation and planning.
• Adhere to safety, DEA procedures, and department SOPs.
• Perform calibration of analytical instruments.
• Perform qualification of working standards.
• Execute method transfer and method validation.
• Keep the working place clean and tidy.
• Create and maintain clear and concise lab records and documentation (notebooks and computer-based).
• Perform routine maintenance of lab equipment as needed.

Qualifications

• Minimum of ten (10) years of experience in pharmaceutical analytical laboratory.
• Experience with analytical instrumentation, theory and practice.
• Experience with wet chemistry techniques.
• Excellent written and verbal communication skills.
• Minimum BS or equivalent degree in Chemistry or related discipline, MS preferred.

• Understanding of GMP, ICH and FDA guidelines.
• Proficient with Microsoft Office applications such as Excel.
• Excellent project management and problem solving skills.
• A self-starter with a hands-on approach and a can-do attitude.
• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

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