Associate Director at Apex Systems, Inc. in Livermore, CA

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Description

The Associate Director Product Dev & Tech Transfer is responsible for the overall coordination, execution and management of the Research and Development Department in support of company goals. The R&D Department functions in support of company (1) product development which includes, creation of new formulas/ modification/duplication formula troubleshooting, (2) Dealing with clients for technical issues (3)Technical Transfer, Process improvements, operations and product quality objectives (4) Stability studies in-house and as well as with third party (5) Preparation of GMP batches for clinical studies (6) Coordinating for SPF studies Domestic/international, CW, HRIPT, Epi-Ocular studies (7) Qualifying alternative raw materials

Job Responsibilities:

  • Manage R&D projects to meet company goals and deadlines. Projects includes new product development and others
  • Organize R&D projects, work load, equipment and personnel to align with company goals
  • Lay-out plan for work to employees and insure work is completed timely and properly
  • Supervising preparation of GMP batches for clinical studies
  • Trouble shooting production batch issues
  • Maintaining project update data sheet
  • Increase efficiency in department
  • Implement Formulator Software
  • Oversee Creation of RM folders which includes issuing RM codes, providing cost, lead time, supplier info
  • Oversee Preparation of Manufacturing documents, which includes – issuing BOM codes, preparation of BOM, Manufacturing procedure, Specifications, MSDS, Excel BOM
  • Recommend process and procedure improvements
  • Work with Sales and Clients to insure successful launch of new product and customer satisfaction
  • Manage R&D personnel, including training, mentoring, performance evaluation
  • Manage R&D lab equipment and supplies.
  • Manage R&D documentation process, which includes create, edit, review and approve
  • Coordinating for method development and validation with third party
  • Oversee Preparation of stability protocols, stability data and summary reports
  • Perform other responsibilities and project as assigned
  • Preparation Final INCIs
  • Oversee Preparation of EU master formulas and providing other documents required for registration purposes
  • Managing/supporting R&D accounting

Product Development:

  • Developing products based on product profiles.
  • Communicating with clients on a regular basis providing updates and suggesting alternatives as needed.

Production:

  • Technical Transfer of new products
  • Updating BOMs based on Tech Transfer
  • Promptly responding if rework is needed
  • Day to day trouble shooting production batch issues
  • Issuing NCMRs if needed
  • Any raw material issues (e.g. Kojic Acid blend grittiness issue; followed with supplier to get much improved raw material)
  • Issuing BOM numbers (and keeping track of active BOMs)
  • Discussing batch sizes etc with planning personnel
  • When alternative suppliers are recommended by materials management reviewing the documents and approving only comparable raw materials

Qualifications:

  • Bachelor’s+ 20 years, Master’s + 12 years, or Ph.D. degree + 8 years significant and relevant cosmeceutical development and manufacturing experience
  • Significant technical leadership experience with direct accountability for managing a team of direct reports.
  • Develops and uses knowledge and interpersonal skills to influence and guide internal and external stakeholders effectively adapts well to different personalities and manages others in a respectful manner
  • Project management skills and familiarity with financial aspects related to projects including ability to anticipate and manage internal and external resource needs (people, information, technologies, time, and capital)
  • Demonstrated independent thought/creativity in science and success in coordinating and executing research to further corporate goals
  • Demonstrated ability to successfully direct multiple scientific endeavours simultaneously
  • High-level technical skills, with demonstrated application and creativity
  • Excellent communication, collaboration and multitasking skills and ability to work in a team setting
  • High degree of scientific discretion/intuition
  • Conveys ideas in an experimentally detailed yet scientifically concise manner

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.


VEVRAA Federal Contractor
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.

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