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Associate Director, Formulation Development

Company: BioDuro
Location: San Diego
Posted on: February 24, 2021

Job Description:

Job Title: Associate Director of Formulation DevelopmentDepartment: Formulation DevelopmentReporting To: VP of PharmaceuticsClassification: ExemptWhat We DoBioDuro is a privately-owned Contract Research, Development and Manufacturing Organization (CRDMO) headquartered in San Diego, CA with more than 1,200 employees globally. Our four facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Discovery Chemistry, Biology and Animal DMPK services through our Chinese facilities, to Formulation Development and cGMP Manufacturing of oral solid dosages, nebulized and inhaled products, gels and topical ointments at our San Diego Headquarters, there is no surprise BioDuro is a leading partner of choice.Why BioDuro?Take the next step in your career and join BioDuro 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 strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.Job OverviewThe Formulation Director assists in the design and development of drug delivery systems and dosage forms. The Associate 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 Associate 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 Duties 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 a team of 3-5 members focused on the formulation development of solid oral drug candidates for preclinical and human clinical studies; prepare for continued growth to a larger team size through new hiring.* 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 to be presented at national/international meetings.* Supports Business Development team by presenting BioDuro's capabilities to prospect customers and assist with business growth.* Provide technical guidance internally to the formulation, analytical and manufacturing teams on the formulation methodologies and issues they face in their work. * 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.* 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;* 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.* Strong mathematic and chemistry skills* Has excellent verbal and written communication skills* Excellent organizational skills; Good troubleshooting and interpretation skillsPosition BenefitsBioDuro employment provides the opportunity to work in beautiful San Diego, California, with the possibility of international travel to our facilities in Jiangsu, Shanghai, and Beijing. We offer full health benefits, paid time off, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, BioDuro provides employees with daily free catered lunch, and a variety of engaging employee and community outreach events. We work hard to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity.EOE and AccommodationWe 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, national origin, disability, protected veteran status, sexual orientation or gender identity. BioDuro 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 careers@bioduro.com. 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 RepresentativesBioDuro is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any BioDuro employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of BioDuro. 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 JazzHRdPDifkIpN4

Keywords: BioDuro, San Diego , Associate Director, Formulation Development, Executive , San Diego, California

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