Executive Director, Bioprocess 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, this position will be responsible for providing strategic input relates to CMC decisions and will contribute significantly to the development and success of the Manufacturing Sciences team. Partner with other functional leaders from Analytical, Formulation, Supply Chain, Contract Manufacturing Organization (CMO) management and Quality in support of the project teams and of the organization.
This position will lead the Bioprocess team for clinical and commercial manufacture of mAbs and fusion proteins. The responsibilities include oversight of the development of upstream and downstream processes at CMO, oversight of cGMP manufacturing at CMO, oversight of process characterization and process validation activities at CMO, commercial launch planning, and support of regulatory submissions including BLA preparation and filing. In addition, this individual will be accountable for overall management of the function such as resource planning, employee engagement and workflow enhancement.
- List of primary/essential duties, tasks, include discretionary judgement when appropriate.
- Oversees CMO activities for cell line development for the selection of production cell line for master cell bank manufacturing.
- Oversees cell culture process development, optimization, characterization/validation, and scale up at CMO’s.
- Manages process development experimental design, execution and writing process development plans/reports.
- Reviews and approves batch records and SOPs; addresses production issues at CMO’s in collaboration with quality and regulatory teams.
- Acts as a mentor for the junior staff, provides training and emphasizes best practices.
- Partners with QA and Regulatory to support batch releases and regulatory submissions including BLA preparation and filing.
- Sits in Manufacturing Sciences leadership team to assess and support CMC strategy
People Manager responsibilities (resource planning, coaching, decision making).
- 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 biochemistry, chemical/biochemical engineering or related disciplines
- 15+ years of in-depth technical experience in bioprocess development for protein drugs.
- Solid knowledge and experiences in mammalian cell culture process engineering and process scale-up/scale-down design is essential.
- Management experiences in biotech/biopharmaceutical industry is required.
- Experience with commercial manufacturing and launch of new products preferred.
- Proven experience in process characterization, process validation and BLA preparation.
- Hands on experience with technology transfer of manufacturing process.
Skills and Abilities
- List technical, interpersonal, and leadership (where appropriate) skills and abilities to be successful in the position.
- Must be scientifically knowledgeable, team-orientated, and passionate in biopharmaceutical development.
- proficient on cGMP’s, regulatory guidelines, validation practices, and other relevant regulatory requirements.
- Excellent written and oral communication 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.