Senior/Director Formulation Development

Job Title: Sr./Director of Formulation Development Department: Formulation Development Reporting To: VP of Pharmaceutics Classification: exempt, full-time What We Do BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees. Our US operations are US headquartered in San Diego, CA. Our 10 facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects . With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice. Why BioDuro-Sundia? Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success. Job Overview/Summary The Formulation Development Director leads the team in the design and development of drug delivery systems and dosage forms . The Director of Formulations will work closely with a wide variety of global pharmaceutical clients, with the major focus on the design and development of drug delivery systems and dosage forms, including technologies such as spray drying and HME. They will drive processes and projects from the bench all the way up to 100+ kg scale, managing these key pipeline projects to the point of providing impactful pre-clinical drugs for BioDuro clients. The Director will utilize critical project management skills to make important decisions and reach/hit deadlines to ensure the ongoing service operations and continued success of the business. This individual will also mitigate risk and help clients map out important timelines for their project execution and completion. Overall, this is an opportunity to truly help grow a formulations team and a business in an influential role, take ownership of this important job, and work on a wide variety of exciting projects in the early-stage Drug Discovery field. Essential Functions and Responsibilities Lead client projects by assigning lead formulation and analytical scientists, coordinating kick off meeting presentations, reviewing timeline creations from project management ensuring milestones match proposals and customer required timelines are achievable. Supervise 10-12 team members focused on the formulation development of solid oral drug candidates for preclinical and human clinical studies. Mentor scientists within formulation development and create individual development plans for direct reports. Develop timelines and plan series of experiments as required by service agreements. Coordinate and delegate responsibilities to meet Client''s expectations. Coordinate investigations of aberrant results, determination of root causes and recommends action plan. Review and approve scientific reports, experimental protocols and batch records. Provide technical guidance internally to the formulation, analytical and manufacturing teams on the formulation methodologies and issues. Coordinates idea generation for scientific posters and publications Supports Business Development team by presenting BioDuros capabilities to prospect customers and assist with business growth Represent BioDuro at conferences, trade shows and scientific forums Comply with BioDuro SOP and cGMP practices in documentation and equipment operation. This job description is subject to change at any time. Required Qualifications Ph.D. in Pharmaceutics, chemistry or related scientific discipline with 8+ years (PhD), 12+ years (MS), or 15+ years (BS) of relevant industry experience Hands-on experience with spray drying, hot melt extrusion and functional coating (DR, SR, timed and enteric) is preferred. Proven scientific leadership in multiple areas of formulation chemistry in CMC drug development Successfully lead technical teams in developing and commercializing pharmaceutical drugs in one or more industry organizations. Demonstrated ability to establish new capabilities and innovate strategies in pursuit of scientific excellence. Experience with supervision, mentorship, or management of other team members. Proven talent development skillsets Ability to work in a well-lit heated and/or air-conditioned indoor office and occasional laboratory setting with adequate ventilation. Light physical activity performing non-strenuous daily activities of a productive/technical nature. May require long periods of standing/sitting. Preferred Qualifications Previous development experience with oral dosage forms (capsules, tablets, mini-tablets, granulations, suspensions, solutions, amorphous intermediates, taste-masking, ) is desired. The individual must have demonstrated proficiency in the development of one or more drug product dosage forms. Strong mathematic and chemistry skills Has the discipline to stay focused and complete specific tasks Has excellent verbal and written communication skills Excellent organizational skills Good troubleshooting and interpretation skills Strictly follows the company policy on client confidentiality Position Benefits BioDuro-Sundia employment provides the opportunity to work in beautiful San Diego, California only 5 minutes from the nearest beach. We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, BioDuro-Sundia provides employees with free catered lunch Monday through Thursday, and a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity. EOE and Accommodation We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. BioDuro-Sundia provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing [Click Here to Email Your Resumé]. If you are selected to interview for a position, you may also request an accommodation with our team directly. Notice to Agency and Search Firm Representatives BioDuro-Sundia is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any BioDuro-Sundia employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of BioDuro-Sundia. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Powered by JazzHR

Created: 2026-04-04