In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. We articulated our 2022 winning aspiration to double the number of patients we serve and hence, double the impact we create as a global pharmaceutical company. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division. We at Cipla are inspired by our purpose of 'Caring for Life' and strive to extend this philosophy to our associates and their families. We are looking for talented individuals to grow their careers while growing our business.
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 Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.
The ‘ Senior R&D Scientist, Sterile Injectable / Parenteral Formulations’ position is an individual contributor role and reporting to the Associate Director of Research & Development (R&D) at InvaGen/Cipla New York. The job duties for this position include but are not limited to the following:
Operate as the subject matter expert (SME) on pre-formulation and formulation, process development and technology transfer as applied to sterile injectable / parenteral formulations. Products may range from vials, ampoules, infusion bags, pre-filled syringes etc.
Lead formulation and process development, product characterization, process analytical technologies (PAT) and incorporation of active pharmaceutical ingredients (APIs), excipients, packaging material and devices to develop finished products. Products may range from internal product development projects, products that are commercialized, products that are in-licensed from external entity or products that are co-developed with a development partner.
Conduct API, excipient, packaging or device characterization; excipient compatibility and forced degradation studies. Recommend stage appropriate acceptance criteria for vendor and regulatory specifications. Utilize relevant theoretical modeling and statistical tools, as required.
Develop robust lab-scale, pilot-scale and commercial-scale manufacturing process based on Quality by Design (QbD) principles using design of experiments (DOE). Recommend stage appropriate acceptance criteria. Utilize PAT where feasible. Utilize relevant statistical tools, as required.
Review and analyze relevant stability data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction. Develop and implement strategies to control related substances, where applicable.
Work with relevant cross-functional stakeholders (e.g., Commercial Operations, Quality Control, Quality Assurance etc.) on scale-up and technology transfer of processes from R&D to commercial functions.
Lead and/or participate in activities related to process development, process verification/qualification, process pre-validation, process validation, site and equipment qualification in collaboration with relevant stakeholders.
Act as single-point technical contact for contract development and manufacturing organizations (CDMOs) or contract research organizations (CROs). Collaborate with project management (PM) function to lead execution of activities against approved plan.
Provide relevant subject matter expertise in collaboration with external partners in the form of participation in technical strategy discussions; consultation on technical studies; hands-on characterization and/or third-party interface (e.g., CDMOs, CROs etc.)
Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).
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.
Independently draft and/or review standard operating procedures (SOPs).
Maintain effective and pro-active communication and coordination of activities with multi-functional stakeholders.
Draft and/or participate in drafting relevant sections of dossiers towards 505(b)(1), 505(b)(2) or 505(j) submissions. Lead studies in support of responses to United States Federal Drug Administration (FDA) information requests or deficiency letters for various dossiers.
Train peers and junior staff members on new techniques.
TYPICAL DAY-TO-DAY ACTIVITIES
New product development
R&D activities such as pre-formulation, formulation, process development or analytical method development
Primary Packaging development and optimization
Leading activities at CDMOs
Drafting dossier supportive documents
Drafting and responding to relevant requests from the US FDA or EU authorities
Working with external partners on technical activities
EDUCATION AND EXPERIENCE
Doctorate in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.
Four (40 years of experience with basic concepts of sterile injectable / parenteral products is a must.
In-depth understanding of physical pharmacy, physical chemistry, thermodynamics, chemical reaction kinetics is a must.
In-depth understanding of various pre-formulation and formulation studies including excipient compatibility, forced degradation studies and unit steps in formulation manufacture is a must.
Experience with pilot-scale and manufacturing-scale equipment is a plus.
Experience with process analytical technologies (PAT) is a plus.
Experience with drug-device combination basics and operational aspects in a plus.
Experience with selection of primary packaging options is a plus
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. Past publication experience 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.
OTHER JOB INFORMATION
Employment sponsorship negotiable.
No remote work available.
Must be willing to work some weekends based on a relevant business need, if required.
Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.
GLOBAL COMPANYCipla 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, anti-depressants. The company was founded in 2003 and is based in Hauppauge, New York and Fall River, MA. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.