Chemist - Analytical Development

Cipla • Central Islip, NY

7h • Onsite

About The Position

Cipla (InvaGen) Pharmaceuticals Inc. is looking for an Analytical Chemist position in CMS group (Chemistry, Manufacturing, Science) in Research & Development at our US facility in Central Islip, New York. Cipla Pharmaceuticals is a Generic Business focused on products in a wide range of therapeutic interests. The CMS Analytical Chemist position is an individual contributor role and hands-on role reporting to a Manager of Research & Development (R&D) at InvaGen/Cipla New York. If you are an individual with domain expertise who enjoys working in a laboratory with various analytical instruments, this position will be a perfect fit for the joy of work. Cipla (InvaGen) Pharmaceuticals offers an opportunity to work in Generic Products business. This role is a unique opportunity to build a business with the backing of a 90-year-old plus a legacy of sophisticated expertise in dosage forms, CMC, large scale manufacturing, and drug discovery. Cipla has a proven performance track record in 80 countries with over 1000+ products across various therapeutic categories.

Requirements

• Master’s Degree in Analytical Chemistry/Pharmaceutical Sciences or relevant field is required.
• Minimum of 2+ years of experience in respective areas is preferable.
• Able to work both independently and in a project team environment.
• Show initiative and interest in professional development.
• Possess good written and verbal communication skills.
• Basic knowledge in computer programs, word, excel, PowerPoint and Minitab.
• In-depth understanding of analytical methods, theoretical principles of laboratory analytical techniques, physical chemistry is a must.
• Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.
• Strong command over written and verbal English is a must.
• Must be able to work under minimal supervision and able to work independently and in a team environment.
• Must be able to exercise appropriate professional judgment on matters of significance.
• Must be proficient in computer skills and software applications such as Microsoft Office tools.
• Must communicate clearly and concisely across levels, both orally and in written

Nice To Haves

• Knowledge of statistical packages is a plus.

Responsibilities

• Independently develop, assess and/or verify and validate analytical test methods for APIs, excipients, packaging components, and drug products using industry standard methodologies including QbD principles for analytical methods; US FDA or EU guidance’s and requirements; United States Pharmacopoeia (USP) guidelines; International Council for Harmonization (ICH) guidelines
• Operate as the subject matter expert (SME) on analytical methods for products that are under development, site transfer, Alternate Vendor Development (AVD), new product launches, trouble shooting for commercial products
• Conduct routine and non-routine analyses of raw materials, in-process materials, stability and finished drug products
• Lead analysis of samples for various R&D and GMP stability studies
• Lead drafting of product specifications and analytical procedures
• Draft high-quality documents in support of dossiers (protocols, reports, technical memos)
• Lead investigation for quality events (planned and unplanned deviations) with appropriate justifications
• Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).
• Develop efficient and selective analytical procedures and draft/review laboratory SOP’s
• Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to line functions.
• Identify discrepancies, initiate, and investigate OOS/OOT results
• Independently draft and/or review standard operating procedures (SOPs)
• Skilled and hands-on experience in ICP-MS, ICP-OES, Malvern Particle sizer, DSC, TGA, UV, HPLC, GC, IC & Dissolution instruments
• Operate computer and analytical instrument software, including Empower, Mass Hunter, Chromeleon, Lab solutions and LIMS
• Perform a timely and accurate peer review of analytical test results report/document in notebooks
• Maintain QC lab related system audit trail to ensure compliance with industry standards
• Support equipment validation, calibration, maintenance and troubleshooting
• Collaborative team player with excellent communication skills working in a highly dynamic, cross disciplinary environment
• Flexibility, ability and commitment to work on multitask projects to meet expected deadlines
• Basic knowledge of cGMP, GLP, ICH, USP and FDA quality guidelines
• Participate in internal assessments and audits as required
• Train peers and junior staff members in new techniques

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level