Job description

R&D Inhalation Chemist

Central Islip, New York

Experience: 2 - 5 Years

Full Time Position

Job Description

· Possess good understanding of the analytical techniques for inhalation products like metered dose inhaler (MDI) and dry powder inhaler (DPI) etc.

· Operate as the subject matter expert (SME) on analytical methods for inhalation products that are under development and site transfer or products that are commercialized.

· Operate as the subject matter expert (SME) on inhalational 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.

· Conduct preformulation studies for orally inhaled drug products following regulatory guidelines, industry best practices, US FDA cGMPs.

· Perform analytical techniques like APSD using ACI/NGI, DUSA, Particulate matter, Spray pattern, Plum geometry, HPLC, UPLC, UV, GC, LC-MS, Viscometer, Karl-Fisher, IR, Particle size analyses, XRPD, DVS.

· Evaluate material from new vendors for suitability of material based on physico-chemical properties and perform studies in support of vendor qualifications.

· Conduct characterization studies and analysis of material in the laboratory.

· Lead drafting of product specifications and analytical procedures.

· Lead analysis of samples for various R&D and GMP stability studies.

· 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.)..

· Independently draft and/or review standard operating procedures (SOPs).

· Maintain effective and pro-active communication and coordination of activities with multi-functional stakeholders.

· Lead studies in support of responses to United States Federal Drug Administration (FDA) information requests or deficiency letters for various dossiers.

· Write reports for US FDA submissions such as a Quality Overall Summary.

· Train peers and junior staff members on new techniques.

Education and Experience

· Doctorate in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry with inhalation knowledge.

· Masters in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry with at least one (1) year of inhalation experience

· Bachelors in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry with at least 3-5 years of inhalation experience.

· In-depth understanding of inhalation analytical methods, theoretical principles of laboratory analytical techniques, physical pharmacy, physical chemistry, thermodynamics, chemical reaction kinetics is a must.

· 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.

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

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

Other Job Information

· Relocation negotiable.

· Employment sponsorship negotiable.

· No remote work available.

· Must be willing to work some weekends based on business need if required.

Must-Haves

Education/qualification:

· Doctorate, Masters or Bachelors in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry with inhalation knowledge.

· Top 3 Mandatory Skills: In-depth understanding of inhalation analytical methods, theoretical principles of laboratory analytical techniques, physical pharmacy, physical chemistry, thermodynamics, chemical reaction kinetics is a must.

· In depth understanding of UV-Vis, Liquid Chromatography (LC), Gas Chromatography (GC) and Spectroscopy techniques such that IR is a must.

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

· Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices

· No Poach Clients (Plus other Strict No-Nos)

· Candidate must have inhalation experience.

Nice to Haves

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

· Target Companies

· Additional Guidelines

· Relocation negotiable.

· No remote work available.

Job Type: Full-time

Pay: $75,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Evening shift
• Monday to Friday
• Night shift
• Overnight shift

Supplemental pay types:

• Signing bonus

Ability to commute/relocate:

• Central Islip, NY 11722: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• inhalation: 4 years (Preferred)
• HPLC: 4 years (Preferred)
• Gas Chromatography: 3 years (Preferred)

Work Location: In person

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