Lab Information Systems Specialist

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

Job summary

Join a forward-thinking company as a Laboratory Information Systems Specialist, where you will leverage your pharmaceutical chemistry expertise to lead the implementation of cutting-edge laboratory systems. This role involves optimizing processes, ensuring compliance with industry regulations, and collaborating with a dynamic team to enhance laboratory operations. With a commitment to innovation and quality, this opportunity offers a chance to make a significant impact in the pharmaceutical sector. If you are passionate about improving healthcare through technology and have a strong background in laboratory systems, this position is a perfect fit for you.

Benefits

Medical, Dental, Vision Benefits

Health Savings Account (HSA)

Flexible Spending Account (FSA)

Prescription Drug Coverage

Telehealth Services

Income Protection Benefits

401k Company Match

Group Life Insurance

Wellness Programs

Corporate Discounts

Qualifications

• 8+ years in the pharmaceutical industry with a focus on laboratory systems.
• Experience with HPLC, GC, and LIMS implementation is essential.

Responsibilities

• Lead LIMS implementation and optimize laboratory systems.
• Ensure compliance with FDA guidelines and maintain document integrity.

Skills

Pharmaceutical Chemistry

Project Management

Problem-Solving

Communication Skills

Intermediate English Proficiency

Education

Bachelor's Degree in Chemistry or related discipline

Degree in Computer Software

Tools

LIMS

SAP

HPLC

GC

UV-VIS

Microsoft Office

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

Job Title: Laboratory Information Systems Specialist

The Laboratory Information Systems Specialist is a person with pharmaceutical chemist experience, who will act as SME, and will play a key role in the implementation of LIMS and other laboratory systems. This position will also be responsible for creating specifications masters in the SAP system and creating specifications and methods in LIMS.

• Lead implementation of laboratory Information Management System (LIMS) and other laboratory systems in QC Laboratory.
• Act as LIMS Subject Matter Expert and provide training to users.
• Optimize laboratory systems to align with LIMS practices and create/modify Laboratory SOPs accordingly.
• Transfer laboratory specifications and methods from DCM system to LIMS.
• Ensure that the integrity and accuracy of all laboratory documents are maintained; must assess overall document compliance with protocols, SOPs, company policies, and applicable regulations.
• Create new and update current methods and specifications in the LIMS.
• Create specification masters in SAP system and create different quality views.
• Act as writer of technical documents such as methods, specifications, and department SOPs.
• Generate change requests required for analytical documents, and route documents for review and approval. Maintain hard copies and electronic files of technical documents.
• Timely provide the QC documents required for CBE, PAS, and ANDA submission to RA.
• Collaborate with colleagues and external partners to achieve individual and department goals.
• Ensure continuous laboratory compliance by adopting best industry practices and complying with procedure requirements.

Qualifications

• Minimum BS or equivalent degree in Chemistry or related discipline.
• Minimum of eight (8) years of experience in the pharmaceutical industry.
• Degree in computer software is preferred.
• Experience as a chemist with hands-on experience with HPLC, GC, UV-VIS, dissolution, etc.
• Advanced computer skills, and competence with Microsoft Office (Word, Excel, PowerPoint) and Access.
• Must have an understanding of FDA guidelines, ICH guidance, and DEA regulations. Ensures compliance with cGMPs, DEA regulations, safety, and site operating procedures under the direction of Management.
• Must be familiar with proper cGMP practices for analytical laboratories and have working knowledge of basic laboratory instrumental analysis and wet chemistry skills.
• Demonstrate strong communication: verbal, written, and presentation skills.
• A self-starter with a hands-on approach and a can-do attitude.
• Excellent project management and problem-solving skills.
• 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).