Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
We are a small biopharmaceutical company located in Sorrento Valley. Our exciting product is entering into a new late phase of clinical trials.
We are looking for a hands-on Quality Assurance CMC Sr. Manager/ Director to lead the strategy for CMC (chemistry, manufacturing and controls) activities leading to submission and approval of product marketing applications. The incumbent will assist in planning, reviewing, and preparing CMC documentation in CTD format to support clinical development and commercial product approvals. They will provide advice and counsel consistent with regulations.
Primary Duties and Responsibilities
•Coordinate the compilation and writing of CMC sections for products for FDA guidelines.
•Summarize CMC data for regulatory submissions including INDs, CTAs and annual reports.
•Ensure compliance with applicable industry standards, FDA and global health authority regulations, and appropriate guidance.
•Develop and support risk assessments related to change control.
•Lead the development of effective CMC strategies for product development and regulatory submissions, and effectively communicate to development team.
•Interact with regulatory authorities (FDA), as directed.
•Interact with internal and external partners as necessary to support efficient and effective product development and project coordination.
•Performs other related duties as assigned.
•Able to work independently on assigned tasks.
•BA/BS in scientific discipline, with 7 plus years’ industry experience and at least three years regulatory management experience. PhD / PharmD or other advanced degree a plus.
•Working knowledge of the drug development process in general, and CMC requirements in particular.
•Hands-on experience in NDA/BLA filings.
•Strong working knowledge of ICH – GCP guidelines, and FDA regulations/guidelines related to the conduct of clinical trials.
•Prior experience working in manufacturing, pharmaceutical science or other product development function.
•Demonstrated ability to coordinate and work effectively with cross-functional teams.
•Superb attention to detail.
•Ability to multi-task in a time pressured environment.
•Excellent written and verbal communication skills.
•Ability to problem-solve independently.
•Good organizational skills and ability to adhere to timelines.
•Excellent computer skills with the following programs: MS Word, PowerPoint, Excel and MS Project; ability to use ISI writer or comparable templates.
• Proficiency in strategizing, planning, monitoring and problem-solving.
• Some travel is to be expected up to 10%.
Interested parties shall submit a cover letter and CV or resume, as directed in this ad. We will contact qualified candidates via email for next steps and to provide more information.
Qualified candidates please email resume with the position title and #1255 in the subject line of the email to: firstname.lastname@example.org