Director - R&D - Pharmaceuticals/Biotechnology/Clinical Research

The Director, R&D position will lead all research and development (R&D) activities at Cipla Therapeutics. In this role the Director will lead a team comprised of internal resources and contractors with a focus on synthetic organic small molecule active pharmaceutical ingredient (API), 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 Warren, NJ or 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 synthetic organic small molecule products via 505(b)(1) and 505(b)(2) new drug application (NDA) pathways.

- Responsible for all chemistry, manufacturing and control (CMC) activities on multiple projects.

- Manage a team of scientists (internal and contractors) focused on API, pre-formulation, formulation, manufacturing process development, technology transfer, established product support, analytical sciences.

- Lead technical deliverables as related to 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 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, Supply Chain Management, Procurement 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.

- Lead others in the team who are subject matter experts (SME) on analytical methods towards various internal and external projects. Broadly oversee development, assessment and/or verification and validation of 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.

- 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 NDA dossiers towards 505(b)(1) and 505(b)(2) 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

- Technical Troubleshooting

- Technology Transfer

- Process Validations

- Leading activities at CROs and CMOs

- Drafting new drug application (NDA) dossier supportive documents

- Drafting and responding to relevant requests from the US FDA or EU authorities

- Working with external partners on technical activities

- Technical Management

- 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 synthetic organic small molecule formulation and process development

- Minimum 10 years of industry experience with demonstrated expertise in relevant area is required.

- Experience with sterile injectable products is a must to have.

- Experience with development and registration of products through a new drug application (NDA; 505(b)(1) and 505(b)(2)) route is a must to have.

- Experience with complex, depot, long-acting injectables, infusions, is a plus.

- In-depth understanding of physical pharmacy, physical chemistry, thermodynamics, chemical reaction kinetics is a must to have.

- 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 to have.

- Experience with pilot-scale and manufacturing-scale equipment is a must to have.

- Experience with process analytical technologies (PAT) is a plus.

- Experience with basic analytical sciences as related to synthetic organic small molecules is a must and advanced knowledge if 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

- Relocation negotiable.

- Employment sponsorship negotiable.

- No remote work available.

- Must be willing to work some weekends based on a relevant business need, if required.