Neurocrine Biosciences
Sr. Scientific Director, Parenteral Product Development
Neurocrine Biosciences, San Diego, California, United States, 92101
About the Role
Recognized as a strategic internal and external scientific expert and leader. Develops innovative methods for the development and testing of new process formulas, technologies and parenteral products. Involved in implementing a new product scale-up, formulation, drug product process optimization, technology transfer and process validation activities. Drives the development of parenteral formulation procedures and product specifications. Maintains substantial knowledge of start-of-the-art principles and theories and contributes to scientific literature and conferences. Advises Sr. Technical Leadership and executive management on parenterals development and manufacturing, interfaces heavily with device/combination product development efforts, and coaches and mentors members of the product and formulation development group. Your Contributions (Include, But Are Not Limited To):
Direct CMC formulation and drug product process development for clinical candidates Implement innovative approaches in pharmaceutical development projects Lead cross-functional teams and provide strategic guidance on development programs Supervise laboratory personnel and mentor scientists Solve complex technical challenges in pharmaceutical development Present research findings to internal and external audiences Requirements:
BS/BA and 15+ years of experience OR MS/MA and 13+ years of experience OR PhD or equivalent combination of education and work experience and 10+ years of experience Recognized thought leader with deep expertise in biochemical formulation science Applies creative problem-solving to complex pharmaceutical development challenges Proven ability to translate strategy into tactical plans and drive outcomes Influences industry issues impacting Neurocrine Expert in pharmaceutical drug product process development Current with biochemical formulation science and techniques Advanced understanding of cGMP, regulatory requirements, and process validation Parenteral drug manufacturing experience including on-site production support Demonstrates cross-functional drug development knowledge Proven team leadership and research program management Strong mentoring skills Excellent laboratory skills and productivity Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. The annual base salary we reasonably expect to pay is $219,700.00-$318,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
Recognized as a strategic internal and external scientific expert and leader. Develops innovative methods for the development and testing of new process formulas, technologies and parenteral products. Involved in implementing a new product scale-up, formulation, drug product process optimization, technology transfer and process validation activities. Drives the development of parenteral formulation procedures and product specifications. Maintains substantial knowledge of start-of-the-art principles and theories and contributes to scientific literature and conferences. Advises Sr. Technical Leadership and executive management on parenterals development and manufacturing, interfaces heavily with device/combination product development efforts, and coaches and mentors members of the product and formulation development group. Your Contributions (Include, But Are Not Limited To):
Direct CMC formulation and drug product process development for clinical candidates Implement innovative approaches in pharmaceutical development projects Lead cross-functional teams and provide strategic guidance on development programs Supervise laboratory personnel and mentor scientists Solve complex technical challenges in pharmaceutical development Present research findings to internal and external audiences Requirements:
BS/BA and 15+ years of experience OR MS/MA and 13+ years of experience OR PhD or equivalent combination of education and work experience and 10+ years of experience Recognized thought leader with deep expertise in biochemical formulation science Applies creative problem-solving to complex pharmaceutical development challenges Proven ability to translate strategy into tactical plans and drive outcomes Influences industry issues impacting Neurocrine Expert in pharmaceutical drug product process development Current with biochemical formulation science and techniques Advanced understanding of cGMP, regulatory requirements, and process validation Parenteral drug manufacturing experience including on-site production support Demonstrates cross-functional drug development knowledge Proven team leadership and research program management Strong mentoring skills Excellent laboratory skills and productivity Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. The annual base salary we reasonably expect to pay is $219,700.00-$318,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.