Act as a project lead in developing a core technology for Tamper- Resistant Immediate Release Platform Technology of Opiates, for RP/Purdue organization starting from literature/patent research, idea- forming, proof of concept, and lead the formulation, process and analytical development activities. Under limited direction and supervision, carries out design and development of formulations and processes by QbD through filing and/or product launch. Develops and executes formulation strategies related to product development, e.g. project planning and timelines, experimental design, data evaluation, formulation of relevant and scientifically based conclusions, coordinates studies with other technical groups (Analytical Sciences, Legal, and Regulatory & Pharma Tech). Maintains a high level of expertise within the field and develops new technologies and concepts to be applied in the development of NDA/ANDA products. Identifies, analyzes and suggests corrective actions to optimize R&D processes, technology and regulatory compliance issues.
- Project Lead in pharmaceutics and formulation science and responsible for Abuse-Deterrence Platform Technology for Opiates.
- Designs experimental plan; performs pre-formulation, formulation development work and optimize formulation and process by QbD.
- Involved in development of product / raw material specifications including evaluation of physicochemical properties and compatibility of raw materials. Reviews analytical data to support the product development work.
- Plans appropriate analytical testing and stability studies on pivotal batches.
- Writes protocols and batch records to carry out process development and evaluation work, scale up and pivotal batch manufacturing for NDA / ANDA's submission to regulatory agency.
- Prepares pharmaceutical product development report (PDR), Quality overall Summary (QOS) and other necessary documents to support regulatory filing.
- Surveys the scientific literature and performs patent search to remain current with recent developments in generic pharmaceutical research and regulatory area and novel drug delivery systems.
- Plans bioequivalence studies on drug product and evaluates the bioequivalence data to recommend changes in formulation, if needed.
- Maintains appropriate documentation of primary data records, report sheets and laboratory notebooks as required by Standard Operating Procedures.
- Performs related duties as assigned.
MS or PhD in Pharmacy or Pharmaceutical Technology or chemistry with eight plus years of experience for MS and five plus years experience for PhD in developing various dosage formulations.
Required Experience & Technical Requirements
- Advanced knowledge of theories, practices and principles of physical pharmacy, pharmaceutics, pharmacokinetics, biopharmaceutics and statistical designs.
- Product formulations, product stability, packaging, and FDA submission methods and practices.
- Product design of controlled release dosage forms, working knowledge of multiparticulate systems, matrix systems, diffusion controlled and osmotically engineered pharmaceutical dosage forms.
- Experience with other dosage forms is a plus.
Purdue Pharma L.P. and its associated U.S. companies are known for pioneering research on the principal cause of human suffering: chronic pain. Headquartered in Stamford, Connecticut, it is one of the fastest-growing pharmaceutical companies in the world today. Purdue Pharma has led the battle against inadequate treatment of pain by developing long-acting pain-control medications that are prescribed by healthcare professionals around the world. As the sponsor of Partners Against Pain, the company provides community outreach and educational programs to encourage the therapeutic alliance of patients, their families, caregivers, and healthcare professionals.
Benefits: Purdue offers a wide range of competitive benefits to all full-time employees. Our benefit package includes a variety of benefit programs to provide for the health, welfare and financial security of our employees and their families.
We are an Equal Opportunity Employer committed to a diverse workforce, M/F/D/V. Corporate standards require pre-employment drug testing and background investigation.
If you are interested in a specific open position, you must apply online by visiting our website at www.purduepharma.com . No hard copy resumes will be considered.
Purdue Pharma L.P. - 30+ days ago