Chemist - Analytical Development

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates.

Job Title: CMS Analytical Scientist


Division: Research & Development


FLSA Classification: Professional, Exempt


Work Location: Central Islip, NY


Work Hours: General Shift (8:30am-5:00pm)


Salary Range: $67,600 - $90,400


Report To: R&D Manager

Summary:


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.

Responsibility:

• 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

Qualifications:

• • 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.

PROFESSIONAL COMPETENCIES AND TECHNICAL SKILLS

• 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.
• Knowledge of statistical packages is a plus.
• Must communicate clearly and concisely across levels, both orally and in written

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

GLOBAL COMPANY


Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.


Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)


About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

Equal Opportunity Employer Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.

About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.