The Associate Director, R&D position will lead all research and development (R&D) activities at Cipla NY (Invagen Pharmaceuticals Inc.). In this role the Associate Director will lead a team of scientists comprised of formulation, process development, technology transfer and analytical sciences. This position will report into the Senior Vice President and Head of R&D, North America. This position is based out of Long Island, NY.
The job duties for this position include but are not limited to the following:
Lead all R&D activities as related to development and registration of products via 505(b)(1), 505(b)(2) and 505(j) pathways.
Lead a team of scientists comprised of pre-formulation, formulation, manufacturing process development, technology transfer, established product support, analytical sciences with a focus on active pharmaceutical ingredient (API), excipients, intermediates and finished products.
Lead internal pipeline projects and collaborations with development partners (strategic development partners, CROs, CDMOs etc.).
Manage scope, cost, time of projects as related to delivery against business objectives.
Operate as the subject matter expert (SME) on pre-formulation and formulation, process development and technology transfer or analytical sciences as applied to development, 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 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.
Operate as the subject matter expert (SME) on analytical methods for various internal and external projects. Independently develop, assess and/or verify and validate analytical test methods for APIs, excipients, packaging components, devices 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. Techniques may include standard tools like HPLC, UPLC, UV, GC, LC-MS, Viscometer, Karl-Fisher, IR, Particle size analyses, XRPD, DVS, Rheometer etc. to more specialized techniques such as LS-MS/MS, NMR, SS-NMR, Synchrotron etc.
Act as single-point technical contact for contract research organizations (CROs) and/or contract development and manufacturing organizations (CDMOs). 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., CROs, CDMOs 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 staff, 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
New Analytical Method Development
Leading activities at CROs and CMOs
Drafting dossier supportive documents
Drafting and responding to relevant requests from the US FDA or EU authorities
Working with external partners on technical activities
Functional Group Management
EDUCATION AND EXPERIENCE
Doctorate in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.
Minimum 10 years of industry experience with demonstrated expertise in relevant area is required.
The successful candidate may have specific background in Formulation and Process Development and/or Analytical Sciences.
For a candidate from the Formulation and Process Development workstream, experience with sterile injectable products such as complex, depot, long-acting injectables, infusions, is a plus.
For the Formulation and Process Development workstream, in-depth understanding of physical pharmacy, physical chemistry, thermodynamics, chemical reaction kinetics is a must.
For the Formulation and Process Development workstream, 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.
For the Formulation and Process Development workstream, experience with pilot-scale and manufacturing-scale equipment is a plus.
Experience with process analytical technologies (PAT) is a plus.
For a candidate from Analytical Sciences workstream, experience with analysis of peptide, proteins, bio-physical characterization and techniques such as Bio-NMR, ITC, DSC, DLS, SLS, CD, Fluorescence, UV-Vis, SPR, HPLC, UPLC, MS is a plus.
For the Analytical Sciences workstream, in depth understanding of UV-Vis, Liquid Chromatography (LC), Gas Chromatography (GC) and Spectroscopy techniques such that IR is a must. Experience with analytical techniques such as dissolution, particle size analysis, dynamic vapor sorption (DVS), x-ray powder diffraction (XRPD), mass spectrometry (MS), nuclear magnetic resonance (NMR) etc. is a plus.
For the Analytical Sciences workstream, in-depth understanding of theoretical principles of laboratory analytical techniques 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. 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
No employment sponsorship.
No remote work available.
Must be willing to work some weekends based on a relevant business need, if required.
Additional Salary Information: Variable Pay/Bonus is 20%.
Internal Number: ADCiplaNY102019
About InvaGen Pharmaceuticals, Inc. (Cipla New York)
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 company is also referred to as Cipla New York.
The Cipla New York site consists of three manufacturing facilities and a diverse workforce performing a variety of roles such as senior scientist, quality control chemist, quality assurance associate, regulatory affairs analyst, manufacturing and production operators, and other business and technical positions.