Associate Director/Director

Associate Director/Director, Pharmaceutical Development About the Position This position, in collaboration with and through active management Contract Development and Manufacturing Organizations (CDMOs), ensures that drug product supplies are available in a timely manner at various stages of clinical development and commercialization. This position also designs and develops drug products for new chemical entities with focus on formulation, manufacturing process development (oral solid dosage form), scaling-up, technology transfer and validation for commercial manufacturing. Essential Duties/Responsibilities: Manage drug product CDMOs and collaborate with internal stakeholders in the development and optimization of drug products, including technical, logistical and project management aspects to ensure program timelines are met. Develop and implement comprehensive strategies for process development including solid form characterization, evaluation of multiple formulation options, process design and optimization, scale-up, and manufacturing of drug product (DP) under both non-GMP and cGMP to enable pre-clinical and clinical studies, respectively. Provide in-depth technical expertise in support of CMC regulatory submissions, due diligence, and other appropriate regulations and guidelines, and active participation in establishment and justification of specifications. Contribute to company strategy by formulating appropriate CMC objectives and priorities in collaboration with the team and drive these objectives and goals through a superior level of scientific knowledge and innovative technical skills. Research and identify new opportunities outside of assigned work that augment the company's mission, vision, values, and goals Communicate professional insight and company's position on CMC issues to internal stakeholders and external partners Influence collaborators and consultants by demonstrating a deep understanding of all aspects of the company's projects, data, results, and objectives Critically review and challenge the work of CMC team members while offering discerning input and solutions Accept ownership for accomplishing new and different requests; explore opportunities to add value to job accomplishments Improve quality results by studying, evaluating, and re-designing processes and implementing changes Work across internal departments to maintain credibility, trust, and support of employees and other stakeholders Demonstrate leadership and professionalism to build external relationships crucial to the success of the organization Maintain scientific records in clear required form Take a leadership role in intellectual property efforts Update job knowledge by participating in educational opportunities; reading professional publications; maintaining professional networks; and participating in professional organizations Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures Perform other duties as assigned by supervisor Requirements: Education, Experience, Skills Ph.D. in Pharmaceutics or scientifically related field or M.S. with additional professional experience 10+ years of related pharmaceutical development and manufacturing experience in CMC/cGMP environment 3+ years of management and oversight of CDMOs for non-GMP and cGMP activities from preclinical through Phase 3. Experience with NDA-related filing activities is desired, but not essential. Ability to navigate and craft global regulatory CMC documents. Subject matter expert with exceptional command of scientific literature in the field and related disciplines Familiarity with safe and efficient laboratory practices General and scientific computer and software application proficiency Salary range: $130,000-$200,000, title and salary commensurate with experience Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan. Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.