Experience : 10 - 15 Years

Annual Salary : Mid 100k-High 100k USD

Work Location : USA

Domain : Pharmaceuticals/Biotechnology/Clinical Research

Job Description :

The Company`s Therapeutics business offers an opportunity to transform a generics company into an innovation-driven specialty business. This role is a unique opportunity to build a business with the backing of an 80-year-old legacy of sophisticated dosage forms expertise, CMC expertise, large scale manufacturing, and drug delivery. Company has a proven performance track record in 100 countries with over 1000+ products across various therapeutic categories. 

Company is known for creating businesses that are sustainable with a high focus on continuous innovation in R&D (with 20+ world firsts so far). Company Therapeutics will focus on Anti-infectives, Pain, Neurology and Respiratory therapies and building out a Branded business. Its Neurology pipeline has two early-stage assets in Spasticity, while in Respiratory, it has a Phase 2 ongoing asset for Aspergillosis in Asthma patients. It also has a Phase 3 completed - opioid-sparing- program for mild to moderate pain in hospital patients. It recently acquired an approved new generation intravenous aminogly coside for cUTI.

JOB DESCRIPTION :

The Director, R&D, Synthetic Organic Small Molecule Analytical Sciences position will lead all analytical sciences research and development (R&D) activities at Therapeutics. In this role the Director may lead a small team comprised of internal resources and/or contractors. 

The focus is on all topics analytical chemistry as applied to synthetic organic small molecule active pharmaceutical ingredient (API), formulation, process development and technology transfer. 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 Analytical Sciences, 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.

- Manage a team of scientists (internal and/or contractors) on all topics Analytical Sciences as applied to API, pre-formulation, formulation, manufacturing process development, technology transfer, and established product support.

- Lead technical deliverables as related to API, excipients, intermediates and finished products.

- Spearhead and/or contribute towards internal pipeline projects and collaborations with development partners (strategic development partners, CROs, CDMOs etc.).

- Operate as the subject matter expert (SME) on analytical sciences including process analytical technologies (PAT). 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. 

- Lead and/or contribute towards 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.

- Generate, 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 analytical method transfers from R&D to commercial functions.

- Contribute towards 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 LC-MS/MS, NMR, SS-NMR etc.

- Act as SME on extractable and leachable strategies and methodology.

- Responsible to be 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 analytical method development and validation

- New Analytical Method Development

- Method Validations

- Technical Troubleshooting

- Technology Transfer

- 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

EDUCATION AND EXPERIENCE :

- Doctorate in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.

- Successful candidate may have specific background in synthetic organic small molecule analytical chemistry.

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

- In-depth understanding of UV-Vis, Liquid Chromatography (LC), Gas Chromatography (GC) and Spectroscopy techniques such that IR is a must to have. Experience with analytical techniques such as dissolution, differential scanning calorimetry (DSC), particle size analysis, dynamic vapor sorption (DVS), x-ray powder diffraction (XRPD), mass spectrometry (MS), nuclear magnetic resonance (NMR) etc. is a plus.

- Experience with extractable and leachable strategy and method development is a must to have.

- In-depth understanding of theoretical principles of laboratory analytical techniques is a must have.

- Application of analytical sciences towards development of sterile injectable products is a must to have.

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

- 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.

- 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 etc. is a must to have.

- Experience with complex, depot, long-acting injectables, infusions, 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 :

- Relocation negotiable.

- No remote work available.

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

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