Establish a robust product pipeline through the development of high opportunity products and intellectual property that supports Rhodes Pharmaceutical Strategic and Financial Goals. Develop both an internal Product Development Team and network of outside development organizations in support of this objective.
Oversight responsibility for Rhodes Pharmaceuticals' product development function, directing both internal and external development activities. Provide technical guidance in Formulation Science, Analytical Science, Technical Transfer and Scale-Up, as well as technical support of commercial products. Position will support the Company's product pipeline development effort and contribute to decisions regarding the Company's Business Development effort.
Principal responsibilities will include:
- Provide leadership in the area of dosage form development from pre-formulation to scale-up, manufacturing validation and commercial readiness.
- Work closely with senior management and lead the product development effort for pipeline products.
- Assist with product and technology evaluations, recommendations and acquisitions.
- Provide input to regulatory guidance decisions before and during product scale-up and technology transfer to commercial manufacturing organizations.
- Work closely with senior management to develop outsourcing strategies, and manage those relationships.
- Develop and execute of scientific programs that would lead to intellectual property for internally developed products.
- Provide supportive CMC documentation for ANDA's, IND's, NDA's, CBE's, 505(b)(2)'s.
- Provide leadership that ensures adherence to product launch timelines.
- Ensure compliance with cGMP, ICH, FDA, state and federal regulations.
- Support pre-approval and annual inspections by regulatory agencies.
- Provide life-cycle management.
- Support Company's resource and budget planning.
PhD with at least 15 years experience in generic product development. Some brand experience would be a plus.
Required Experience & Technical Requirements
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.
- Must have experience with various dosage forms including solids, semi-solids, capsules, injectables, and transdermals.
- Must have a strong analytical chemistry background with demonstrated expertise in basic pharmaceutics.
- Demonstrated leadership abilities to develop and operate within high performance teams.
- In depth knowledge of all applicable regulations.
- Hands-on experience with controlled substances preferred.
- Requires the ability to communicate with employees, vendors, and various levels within Rhodes Pharmaceuticals, Rhodes Technologies, and Purdue.Brief Description/Overview:
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. - 19 months ago