[ref. n8714720] Manager Quality Control Analytical
Overview:
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives.Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
The Manager Quality Control Analytical will manage a group of Quality Control activities at FDBCs Quality Control Bioanalytical laboratories, including raw material, in-process, stability, and product release testing of cell therapy product.
External US:
Manager, Quality Control, Analytical
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives.Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Reports to: Associate Director, Quality ControlLocation: Thousand Oaks, CA
Travel: Up to 10%
Primary Responsibilities:
- Manage a group of Quality Control activities at FDBCs Quality Control Bioanalytical laboratories, including raw material, in-process, stability, and product release testing of cell therapy product.
- Lead and develop a team of QC Associates/Sr Associates/Supervisor in alignment with FDBCs and department objectives.
- Author, review, and approve laboratory procedures, protocols and reports.
- Support cGMP manufacture and supply of high-quality cell therapy products.
- Assess analytical method performance and investigate assay trends.
- Participate in laboratory investigations including Unexpected Results (UR)/Out of Specification (OOS), root cause analysis and implement solutions.
- Identify and implement corrective/preventive actions.
- Review and assess proposed changes to assays and/or QC equipment via CAPA, Change Control and Work Orders.
- Implement phase-appropriate QC capabilities, business processes, and procedures.
- Maintain current knowledge base of regulations and policies to ensure that the QC function remains in compliance with applicable company requirements and global regulations.
- Interfaces with other departments (e.g., Facilities, Information Technologies, Manufacturing, and Quality Assurance) to ensure achievement of FDBCs objectives relating to QC analytical method readiness for new product introductions, including compliance with all applicable standards.
Qualifications:
- Bachelor of Science (B.Sc.) with 7+ years of experience or an equivalent combination of education; or Master of Science (M.Sc.) with 5+ years of experience; or PhD in Science with 3+ years of experience.
- Requires 2-5 years of experience supervising/managing direct reports.
- Experience leading projects with history of achieving results and outstanding outcomes.
- Experience in analytical method qualification, transfer, and validation
- Experience in cGMP cell therapy manufacturing cell-based bioassays, immunophenotyping cell culture, and aseptic technique is a plus.
- Experience working with radioactive isotopes and knowledge of safety regulations a plus.
- Advanced knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues.
- Independent decision-making capability and ability to think conceptually and understand impact of critical decisions.
- Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
- Must possess excellent verbal and written communication skills, good interpersonal skills and a servant leader mindset.
- Knowledge of and the ability to implement CFR, USP, and ICH requirements is required.
- Laboratory investigation, OOS, and root cause analysis experience is required.
- Strong communication skills, team player, and proven negotiation skills.
- Ability to lead, manage and motivate staff.
- Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
- Flexibility to travel as required to accommodate the business needs.
- Ability to identify and implement improvement opportunities.
- Role model for FDBC values (Trust, Delighting our Customers, gemba and genki).
Salary and Benefits:
- $135,000 to $165,000, depending on experience
- Medical, Dental and Vision
- Life Insurance
- 401k
- Paid Time Off
Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.
FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place.In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.