Quality Assurance​/Document Control

Senior Formulation Scientist

Overview: Senior Scientist in Formulation must be able to work independently from bench‑top development through successful submission and approval of ANDA and NDA (505(b)(2)). This role should also assist in supervising, guiding, and following up junior scientists to achieve their respective goals.

Job Type: Full‑time

• Design and perform experiments leading to the development of rational, scientifically sound formulations and manufacturing processes.
• Provide leadership to scientists when appropriate.
• Support regulatory submissions as needed.
• Review compendial requirements for the use of excipients and patent literature.
• Write master formulas, manufacturing procedures, stability reports, SOPs, and product development reports.
• Write specifications for finished products and packaging components.
• Design and initiate stability studies on selected batches of products.
• Evaluate relevant characteristics of raw materials and experimental batches in an effort to develop robust manufacturing practices.
• Oversee the manufacturing of products using production equipment, such as batches for ANDA submissions, bio‑equivalent studies, and/or process scale‑up studies.
• Perform product/process validation when required; including designing procedures, overseeing batch sampling, and analyzing data.
• Coordinate with the Analytical Department for completing testing of new drug products in a timely manner, and developing appropriate controls.
• Coordinate scheduling and production of pilot‑scale and submission batches with Manufacturing Operations and Quality systems.
• Support qualification, calibration, and maintenance of R&D instruments/equipment.
• Responsible for documentation of all activities as per cGMPs and cGLPs.
• Develop and maintain knowledge pertaining to cGMP documents and guidance, other FDA/ICH guidance, and SOPs.
• Perform other tasks as assigned by the supervisor.

Requirements:

• Ph.D. in Pharmaceutics, Materials Sciences, or related discipline with a minimum 2 years’ experience (or MS with 5+ years’ experience) in Drug Product development of small molecule oral liquid dosage forms (solution/suspension/powder for oral suspension). Experiences in emulsion, nano/micro suspension, and micro‑encapsulation are preferred but not required.
• Strong oral and written communication skills, and possessing good interpersonal and team‑working skills.
• Demonstrate skill for problem‑solving, prioritizing objectives from multiple projects, and meeting scheduled timelines while maintaining attention to detail.

Overview: The Analytical R&D laboratory supports development and validation of analytical test methods, evaluation and testing of raw materials, and testing of non‑commercial materials to support product development. All activities are performed in accordance with specifications, standard operating procedures, approved test methods, and/or protocols, regulatory requirements.

Job Type: Full‑time

• Analysis of finished products, in‑process materials, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods, and protocols.
• Preparation of reagents/standards/media needed for analysis according to established methods.
• Disposal of hazardous waste by following environmental regulations and company/departmental procedures.
• Tabulation and interpretation of results of analysis as recorded in notebooks, reports, and logbooks.
• Assure right‑first‑time execution of departmental methods and SOPs.
• Audit and verify results, including but not limited to calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data.
• Write and review analytical methods, deviations, protocols, SOPs, and any other technical documents.
• Provide support for ordering and maintaining inventory of laboratory materials and equipment.
• Perform other miscellaneous duties as required.
• Work flexible hours including weekends and evenings to accommodate the production/validation schedule.

Qualifications:

• Bachelor’s degree from a four‑year college or university in any of the following disciplines:
  Chemistry, Biology, Microbiology, or related sciences (as applicable).
• M…