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Associate Director/Director of Formulation Development

Company: Ascent
Location: South San Francisco
Posted on: June 8, 2021

Job Description:

Associate Director/Director of Formulation Development
South San Francisco, CA

Seeking an exceptional and highly motivated individual to lead the Formulation Development group. The individual will lead formulation activities across a dynamic development and discovery space, develop reliable & cost-effective outsourcing strategies for drug product development from concept to CTM supply. The successful candidate will be flexible, have strong leadership skills, and is well versed in formulation design and pharmaceutical development for both small molecules and biologics.

Responsibilities

  • Develop phase appropriate sterile liquid, suspension, and lyophilized formulations for parental and ocular clinical administration
  • Perform pre-formulations experiments in-house and work closely with internal discovery organization to develop appropriate GLP formulations for IND enabling tox studies
  • Work closely with other senior members of the Technical Operations group to evaluate and select pharmaceutical development and manufacturing CROs and CMOs that are well aligned with the development strategy
  • Project leadership and management of multiple drug product CMOs/CROs, including technology transfers and person-in-plant as part of outsourcing oversight,
  • Serve as relationship manager for drug product CMOs/CROs to insure appropriate resources dedicated to projects on an on-going basis
  • Lead contract negotiation for drug product development activities at CMOs/CROs to insure cost projection well aligned with budgetary estimates
  • Serve as the Operations group representative on internal multidisciplinary project teams
  • Review and approve master batch records, stability, and development reports for GMP activities
  • Authorship of regulatory documents, including IND and IND amendment and technical reports
  • Development of immediate release and controlled release PLGA formulations and work closely with DMPK in evaluating these formulations in appropriate animal models
  • Ability to coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or deviations
  • Alignment and understanding of phase appropriate analytical and quality requirements for GMP drug products
  • Up to 15% travel to foreign and domestics contractors for scientific project management and monitoring of critical project activities

Qualifications
  • Ph.D. in pharmaceutical sciences, chemical engineering, or chemistry with a minimum of 12 years of pharmaceutical industry
  • Successful track record of developing clinical formulations. Commercial experience not necessary but desirable
  • Experience with and first-hand use of common pharmaceutical and analytical equipment
  • Extensive understand of GMPs, GLPs, ICH guidelines, and industry best practices
  • Experience with lifecycle product management
  • Strong verbal communication, written communication, and organizational skills
  • Ability to work collaboratively on multiple projects with numerous stakeholders in and outside of the Technical Operations group
  • Familiar with the overall drug development process beyond pharmaceutical development


Company Description:

About Ascent:

Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascents fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.

If you are ready to propel your career to new heights read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

Keywords: Ascent, South San Francisco , Associate Director/Director of Formulation Development, Other , South San Francisco, California

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