Director, Analytical Development
- South San Francisco, CA, USA
- Employees can work remotely
Five Prime is a clinical stage biotechnology company relentlessly focused on rewriting the narrative for people with cancer. By tackling the tough scientific questions and untapped pathways, we aim to offer new hope by developing novel, breakthrough therapies that have potential to alter the course of disease in cancers with few treatment options. This vision is what defines us, and guides our research, clinical development and partnerships. To build a better tomorrow for people with cancer, we are teaming up with patients, physicians, scientists, and industry partners to make a meaningful difference in patients’ lives. Five Prime collaborates with leading global pharmaceutical companies and has therapies in pre-clinical and clinical development. For more information, please visit www.fiveprime.com.
At Five Prime, we are relentlessly focused on rewriting the narrative for people with cancer. We tackle the tough scientific challenges with optimism and courage. Rather than pursue the well-trodden path, we explore untapped pathways that have potential to deliver truly novel, breakthrough treatments for cancers with few options.
Together with patients, physicians, scientists, and industry partners we start each day looking for ways to advance science and use our expertise to develop cancer treatments that provide a fresh start and renewed hope for people facing the challenges of cancer.
We do things in a way that truly matters for patients. We embrace this spirit with pride; with action over words. We bring boldness, passion and commitment to each decision in the fight against cancer, however big or small. We are committed to transforming a cancer diagnosis from a foregone conclusion to a more hopeful future. Let’s rewrite the cancer story. Together.
Reporting to the VP Manufacturing Sciences, The Director, Analytical Development will be responsible for providing strategic input relating to CMC decisions and will contribute significantly to the development and success of the Manufacturing Sciences team. The Director will partner with other functional leaders from Bioprocess, Formulation, Supply Chain, Contract Manufacturing Organization (CMO) management and Quality in support of the project teams and of the organization.
The Director will lead the analytical development function to support clinical and commercial manufacture of mAbs, fusion proteins, and other novel biologics. The responsibilities include development of robust release and characterization assays, providing analytical support to other functions, oversight of assay transfer to CMOs, oversight of analytical method validation at CMOs, and support product release and regulatory submissions including BLA preparation for late-stage programs. In addition, the Director will co-chair the specification committee and be accountable for overall management of the function such as resource planning, employee engagement and workflow enhancement.
- Key member of the Manufacturing Sciences leadership team to assess and support CMC strategy.
- Lead analytical function to develop physiochemical and functional assays to support process and product development as well as product release.
- Manage outsourced analytical experimental design, execution and writing testing methods and qualification protocols/reports.
- Works closely with colleagues in manufacturing sciences to ensure timely analytical support upstream and downstream activities at outsourced laboratories.
- Oversee method validation activities at CDMO
- Stay current with protein analytics and introduce new technology to enhance workflow and capabilities.
- Co-chair specification committee and lead establishment of specifications for drug substance and drug products.
- Provide supervision for assay transfer and oversee CMO activities. Review and approve qualification reports and QC SOPs; address testing related issues at CMO’s in collaboration with Quality.
- Manage reference standards and oversee critical reagent strategy.
- Manage analytical resources and strategic planning to support early and late-stage projects. Act as a mentor for the junior staff and emphasize best practices.
- Partner with QA and Regulatory to support batch releases and regulatory submissions.
People Manager responsibilities
- Work with Human Resources staff to recruit, interview, select, hire, and employ an appropriate number of employees based on approved workforce plans.
- Provide oversight and direction to the employees in the department in accordance with the organization's policies and procedures.
- Coach, mentor and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities.
- Empower employees to take accountability for their deliverables and goals. Delegate responsibility and provide regular and timely feedback.
- Foster a spirit of teamwork and unity among department members that allows for collaborative discussions over ideas, conflict and expeditious conflict resolution, and the appreciation of diversity as well as cohesiveness, support and working effectively together to enable each employee and the department to success.
- Consciously create a workplace culture that is consistent with the overall organization’s and that emphasizes the values, operating principles of the organization.
- Lead employees using a performance management and development process that provides an overall context and framework to encourage employee contribution and includes goal setting, feedback, and performance development planning.
- Lead employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment.
- Provide effective performance feedback through employee recognition, rewards, and disciplinary actions, with the assistance of Human Resources, when necessary.
- Education and/or Job Experience combination to be successful in the role.
- PhD in Analytical Chemistry or related disciplines
- 10+ years of in-depth biotechnology technical experience in protein analytical development for molecules from lead selection to clinical development and commercial launch
- Hands on experience on analytical technologies such as HPLC, CE, peptide map, mass spectrometry, ELISA, and cell-based bioassay is required.
- Significant experience with protein characterization and comparability assessment is essential.
- Direct experience on transfer of analytical methods to CMO’s is required.
- Extensive experience in authoring analytical sections for regulatory submissions.
- Experienced with method validation, process validation, and BLA submission.
Skills and Abilities
- Proven capability as a successful leader in a strategic multifunctional environment, highly skilled in leading change and people agility
- Proficient on cGMP’s, regulatory guidelines, validation practices, and other relevant regulatory requirements.
- Demonstrated outside the box thinking to accelerate timeline and problem solve
- Must be scientifically knowledgeable, team-orientated, and passionate about biopharmaceutical development.
- Excellent interpersonal communication and presentation skills.
At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.
FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.
Five Prime acknowledges that providers may be a valuable resource for identifying and recruiting candidates for employment. However, we require that all recruiters engage directly with Five Prime’s Talent Acquisition Team and comply with Five Prime’s requirements prior to transmitting any resumes/CVs or introducing any candidates to Five Prime. Five Prime’s Talent Acquisition Team is the only function within the Company that can enter into contractual relationships with external recruiters and recruiting agencies. As such, all unsolicited resumes, CVs, anonymous profiles, or candidate information you may submit to employees of Five Prime will become property of Five Prime and Five Prime will have no obligation to pay you or anyone else for the use of such information, including any finder’s, placement, introduction or placement fee.