Head of Analytical Development
Location: California
Salary: $225,000 - $300,000
An exceptional Biotech company is looking to bring on a strong scientific leader to run the Analytical Development group, located in the Bay Area. As the department head, you will represent and manage a team of scientists and associates to develop advanced analytical methods for respective project-based needs. Additionally, whilst working with other CMC leaders, you will also participate in controlling the strategic vision for the Analytical group, that will also support the other CMC areas.
This company is currently undergoing massive growth. The team wishes to challenge the conventional methods of drug treatment with a new, ingenious science that will completely change the healthcare infrastructure as we understand it today. If you are someone with a vision and wish to be part of something that will undergo a step-forward into the future of science/tech, then this is the role for you.
JOB RESPONSIBILITIES:
- Lead the Analytical Development group.
- Undergo hiring and training according to the strategic vision for the Analytical Group.
- Create and develop internal structure to ensure that the team will be supported and have all the resources to create analytical methods, according to the strategic vision of the group.
- Be the Subject Matter Expert (SME) for all topics related to Analytical Development.
- Provide strategic vision and guidance for all CMC filing activities (whether it be for pre-INDs, INDs, IMPDs, BLAs, or CTAs).
- Establish and create external vendor partnerships for any outsourcing needs for the Analytical Group.
- Collaborate with the other company CMC leaders to assess strategic vision and specific plans of action for CMC related activities.
- Institute best business/scientific practices for analytical method development. (Also practices working with the Quality department, writing technical reports, writing SOPs)
- Institute strong training and give regular performance review for the internal team. Provide development tracks for scientists and associates and provide coaching as needed.
JOB REQUIREMENTS:
- Doctor of Philosophy, or Masters Degree, in these scientific disciplines: Chemistry, Biochemistry, Molecular Biology (or other scientifically related majors).
- At least 10+ years of industry experience within Analytical Development, 14+ years with a Masters Degree.
- At least 5+ years of management experience.
- Strong Scientific expertise with analytical method development, qualification & validation (with GMP standards), and product characterization.
- Strong understanding with early to late stage Analytical and QC activities.
- Having experience with regulatory filings, and understanding regulatory expectations, is a huge plus.
- Strong communicative skills and management skills to create a high-functioning team.
