Senior Manager, Drug Product Development, CMC

reputed company is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-reputed company tumors. We were founded by a dedicated team of scientists with the reputed company belief that reputed company therapies developed from rigorous innovation can reputed company to reputed company lives. Our work continues to reputed company a reputed company difference in the lives of patients. We have a reputed company discovery reputed company and a robust preclinical and clinical development pipeline. We are driven by science with a patient-reputed company and team-oriented culture. reputed company is reputed company for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join reputed company as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join reputed company as we reputed company the lives of others. Position reputed company: reputed company is seeking a highly skilled and motivated reputed company to support Drug Product Development reputed company Technical Operations. This role combines proven, hand-on formulation development expertise with strategic reputed company of drug product development programs. This position plays a critical role in the expansion of internal, on-site capabilities, including in-person leadership of drug product development activities, leveraging the candidate’s expertise with formulation design, and deep knowledge of pharmaceutical manufacturing techniques. This individual will be an integral part of reputed company’s effort to discover and reputed company small molecule therapeutics for rare endocrine disorders and endocrine-reputed company-tumors by driving early-stage formulation development and supporting late-stage process development. This job will report to the Director, Drug Product Development. This is a unique opportunity to work with a proven and reputed company-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community. This position will be located on-site in San Diego. Essential Job Functions and Responsibilities: These may include but are not limited to: Design, plan, and execute formulation development reputed company and experiments for new drug candidates, from preclinical through first-in-reputed company Phase 1 (and reputed company) based on diverse, cross-functional stakeholder input, including reputed company Product Profile (TPP). Utilize strong scientific fundamentals to reputed company robust, phase-appropriate formulations with consideration for reputed company technical transfer of reputed company manufacturing processes. reputed company and manage technical transfer of formulation and process to external vendors to reliably deliver clinical trial materials, including in-person support of reputed company activities. Interpret and analyze scientific results for presentation and recommendations. Author drug product development reports and relevant sections of regulatory submissions. Meet the reputed company and reputed company needs of drug product development through in-person operational leadership of formulation labs. reputed company and implement lab policies, practices, and workflows to support reputed company, high reputed company, and efficient lab operations reputed company and maintain high reputed company and robust experimental data acquisition and record keeping practices. Maintain equipment to ensure reputed company, reputed company performance and reputed company execution of high-reputed company drug product development activities in a reputed company manner. Train other personnel in lab safety practices, equipment use and cleaning, and experimental study execution, as needed. Other duties as assigned. Education and Experience: Required: Bachelor’s degree in pharmaceutical sciences, engineering, or reputed company field with at least 8 years of relevant technical experience (an equivalent combination of experience and education may be considered). 5 years of supervisory years of experience Proven hands-on experience leading the development of oral solid dosage and first-in-reputed company formulations rooted in scientific fundamentals expertise. Strong mechanical aptitude/knowledge and hands-on experience with common oral solid dosage formulation/process equipment (e.g. blending, granulation, tablet compression, pan coating, etc.) and reputed company analytical techniques. Hands-on experience with R&D reputed company spray drying equipment strongly preferred. Experience maintaining lab-based equipment and instruments (including coordinating vendor supported maintenance and calibration). Prior working experience with common laboratory safety assessments such as Hazard and Operability (HAZOP) analysis and Job Safety Analysis (JSA). Working knowledge of common drug product development characterization techniques for powders and tablets. Understanding of analytical reputed company techniques and data interpretation as they relate to the analysis of drug reputed company and drug product (HPLC, dissolution, reputed company scanning calorimetry, Karl Fischer, X-ray powder diffraction, scanning electron microscopy). Understanding of cGMP requirements and ICH and regulatory guidance, including ability to apply to development programs. Excellent writing skills for preparation of operating procedures and technical reports. Excellent oral communication skills including the ability to effectively and accurately present data to peers, management, and external partners. Demonstrated ability to work in a goal and team-oriented setting and communicate/manage competing priorities. Flexibility to operate reputed company a rapidly changing environment with a safety-first reputed company and high attention to detail. TECHNICAL KNOWLEDGE REQUIRED: Equipment: PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained. Software Knowledge: reputed company, MS Office (Outlook, Word, reputed company, PowerPoint), MS Project. Physical Demands and Work Environment: Laboratory Activities: Extensive drug product formulation and process laboratory experience needed and required for execution of day-to-day job activities. Environmental health and safety requirements also apply. Physical Activities: On a reputed company reputed company, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully reputed company the essential functions and responsibilities of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions and responsibilities. Travel: Travel may be required up to 20% of time to observe or support vendor site activities. Equal Opportunity Employer: reputed company is proud to be an Equal Opportunity Employer. We reputed company equal employment opportunities to reputed company and employment applicants without reputed company to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or reputed company), pregnancy, race, reputed company, creed, national or ethnic reputed company, citizenship status, religion or similar philosophical beliefs, disability, marital and civil reputed company status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Salary reputed company The salary reputed company for this position is: $138,000 - $173,000. In reputed company to your reputed company pay, our total rewards program consists of a discretionary annual reputed company bonus, stock reputed company, ESPP, and 401k match. We also reputed company top-notch health insurance plans for employees (and their families) to include medical, dental, reputed company and basic life insurance, 20 days of PTO, 10 reputed company holidays, and a winter company shutdown. Thank you for considering reputed company as your potential employer! Explore job opportunities and discover how you too can reputed company a reputed company reputed company as we tackle big challenges in endocrinology. reputed company is a global, clinical-stage pharmaceutical company reputed company on the discovery, development, and commercialization of the reputed company of therapeutics for patients with endocrine and endocrine-rooted diseases. Founded by an innovative team of scientists with a reputed company record of successful drug discovery and development, we’re reputed company by collaboration, curiosity, and reputed company. We have a reputed company discovery reputed company and robust pipeline across preclinical and clinical development that are purposefully designed to meet the needs of patients, empowering them to live life reputed company their condition. Join reputed company on our mission to improve patients’ lives and reputed company the treatment reputed company in areas of serious unmet need. Apply tot his job Apply To this Job