The Associate Director, R&D (Solid Oral Dosage Form Product Transfer) position will lead all research and development (R&D) activities at Cipla NY (Invagen Pharmaceuticals Inc.). In this hands-on role the Associate Director, Technology Transfer, Solid Oral Dosage Forms (OSD), will be responsible for and provide technical leadership as related to technology transfer of product from Cipla network of manufacturing facilities to another internal facility or to an external partner (e.g., CDMO/CRO). 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:
Hands-on leadership of all R&D activities as related to product transfer of solid oral dosage form (OSD) products via the 505(j) pathway.
Provide technical leadership as related to 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.
Single point accountability to lead a team of 1-3 scientists to implement technology transfer projects in a time bound manner to achieve business objectives.
Manage scope, cost, time of projects as related to delivery against business objectives.
Assess product characteristics and specific technologies associated with the products that are required to be transferred to ensure success at the receiving site.
Assess equipment train associated with the approved products that are required to be transferred and use creative approaches to ensure product is successfully transferred with equipment train differences between transferring and receiving sites.
Assess analytical methods associated with the approved products and proactively plan and implement analytical method transfer, verification or validation, as required.
Assess strategy, plan and lead stability studies required to submit regulatory documents as related to qualification of second site.
Work with Cipla global Regulatory Affairs to identify and draft strategy for product transfer; conduct relevant studies; provide and compile data for submission of regulatory approvals as related to qualification of second site.
Work with Cipla global Supply Chain to proactively identify and troubleshoot supply chain topics to meet product transfer business objectives.
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.
Maintain effective and pro-active communication and coordination of activities and deliverables with multi-functional stakeholders across geographical locations.
Maintain effective working relationship and 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.
Train staff, peers and junior staff members on new techniques.
TYPICAL DAY-TO-DAY ACTIVITIES
Equipment train assessment
Analytical method assessment
Consultation with supply chain
R&D activities such as pre-formulation, formulation, process development or analytical method development
Leading activities at CROs and CMOs
Stability study management
Drafting dossier supportive documents
Drafting and responding to relevant requests from the US FDA or EU authorities
Functional Group Management
EDUCATION AND EXPERIENCE
Doctorate in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.
Successful candidate may have specific background in Formulation and Process Development of solid oral dosage forms (OSD e.g., Tablets, Capsules etc.).
Minimum 10 years of industry experience with demonstrated expertise in relevant area is required.
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.
In-depth understanding of pilot-scale and manufacturing-scale equipment is a must.
Experience with process analytical technologies (PAT) is a plus.
Experience with Analytical Sciences 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
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: ADRDExelan102019
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 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.