Scientific Manager, Bioanalytical Development Critical Reagents (Remote Opportunity)

We have an excellent remote opportunity for a Scientific Manager/Sr. Scientific Manager, Bioanalytical Development Critical Reagents to join our Bioanalytical Development team!

Seeking an experienced individual with a protein chemistry, biochemistry, biology or biotechnology background to lead the scientific and business processes for the manufacture, characterization, and control of protein and cell bank critical reagents for bioanalytical methods for the Xencor pipeline.

 Xencor is an innovative, clinical-stage biopharmaceutical company located in the Los Angeles area—near Pasadena—and in San Diego. We use our pioneering XmAb® technology to discover and develop better biotherapeutics, antibodies and cytokines with improved function, with the goal of improving patient outcomes and quality of life. 

Our protein engineering capabilities and the modular nature of our XmAb technology allow us to quickly identify and create new platforms and drug candidates for potential development. We are advancing a deep clinical pipeline of novel drug candidates, including eight bispecific antibodies and two engineered cytokines, and more programs are expected to start clinical testing in 2022. We also leverage our many XmAb technologies by collaborating with leading global biopharmaceutical companies, including Genentech and Janssen Biotech, among others, and including our partnerships, 20 XmAb drug candidates are advancing through clinical development. Three XmAb medicines, to treat patients with a range of serious illnesses, such as aggressive lymphoma, rare blood disorders and COVID-19, are now marketed worldwide by partners.

Our employees are the most important factor in our success, and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees’ value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.

Summary:

This position will manage critical reagent needs for Bioanalytical Development in the Preclinical Sciences Department. The incumbent will lead the scientific and business processes for the manufacture, characterization, and control of protein and cell bank critical reagents for bioanalytical methods for the Xencor pipeline, including those supporting pharmacokinetic, immunogenicity, biomarker, and potency endpoints. The successful candidate will be skilled in protein chemistry/biochemistry and project management.

Job Duties Include:

• Reagent supply chain management
  • Refine processes for identification and prioritization of reagents to manufacture externally or internally
  • Interact with cross-functional teams to meet project goals and timelines
  • Technical review and management of contracts and invoices, and collaboration with Finance on the budget to support critical reagents
  • Qualify vendors for critical reagent services
  • Reagent inventory and logistical support from Xencor Sample Management
• Reagent manufacturing and labeling
  • Support transfer of methodologies optimized for molecule specific transient expression and purification from Xencor Research to non-GMP contract research manufacturers (CMOs) for stable transfection, expression, purification, and characterization
  • Technical monitoring of CMOs supporting the production and/or labeling of proteins and/or assay cell bank reagents
• Reagent characterization
  • Develop workflows for efficient cross-functional technical expert generation of data for characterization of molecule-appropriate physical, kinetic, and/or functional screening and characterization assays to support intended use(s)
  • Critical reagent stability protocol generation, execution, and reporting
• Good documentation practices
  • Critical reagent ELN “knowledge database” of manufacturing, labeling, characterization, and functional performance to refine specifications for critical reagent quality attributes over multiple lots over time
  • Reagent Data Sheet (RDS, i.e., CoA) generation, data verification, and archive (e.g., Veeva document management system)

• Supervisory responsibilities
  • Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization’s policies and procedures.  The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities
• Works closely with associates, scientists and management across departments to provide tactical support for research discovery or development efforts.
• Designs, analyzes, and interprets experimental data
• Creates SOPs, presentations and technical reports
• Communicates data to team members in a timely manner
• Presents data to senior management in departmental or companywide meetings
• Leads, participates and/or presents in group meetings
• Interacts with other departments to coordinate research & development efforts
• Stays informed on evolving techniques and new methods in their field and implements those processes at Xencor as appropriate.
• Ensures compliance with all laboratory safety guidelines, practices and protocols
• Adheres to all department and company-wide policies regarding conduct, performance and procedures
• Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization’s policies and procedures.  The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities

Job Qualifications:

• Bachelor’s, MS or PhD in protein chemistry, biochemistry, biology, or biotechnology.  PhD preferred.  At least 12 years of prior related laboratory work experience is also required, with at least 8 of those years in an industry setting.
• Prior GxP experience in preclinical and/or clinical assay development, including an understanding of general assay needs for biologic therapeutics, is beneficial
• At least 1 year experience supervising direct reports
• Strong problem solver who is highly organized with the ability to multitask and thrive in an environment with rapidly changing priorities
• Excellent interpersonal skills with an ability to work independently and in a team setting
• Prior experience managing contract research organizations, laboratory operations is strongly desired
• Proficient with MS Word, MS PowerPoint, MS Teams, data analysis software (e.g., MS Excel, SoftMax Pro, GraphPad Prism, JMP), ELN (e.g., Benchling), and Sample Management Systems (e.g., Freezerworks)

• Excellent written and oral communication skills, as well as strong organizational skills and attention to detail are essential

• Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices.  Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment.

Physical, Mental and Environment Demands:

The physical, mental and working environment demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The working environment for this role includes working in a research laboratory which may involve running experiments and operating laboratory scale process equipment for sample and data generation.  Occasionally, repetitive tasks, prolonged standing, and the use of PPE for handling hazardous and biohazardous materials may be required.  See additional requirements for laboratory and research related jobs listed below.

The physical demands when working in the office environment are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply.

Specific mental demands for the position are listed above under requirements.  In addition, mental demands for this position include:

• Ability to multitask without loss of efficiency or accuracy, including the ability to perform multiple duties from multiple sources.
• Ability to work and sustain attention with distractions and/or interruptions.
• Ability to interact appropriately with a variety of individuals including vendors, customers and clients.
• Ability to maintain regular attendance and be punctual.
• Ability to understand, remember and follow verbal and written instructions.

Additional Requirements for Laboratory and Research Related Jobs

This role may involve work with experimental subjects and/or specimens including infected samples, plus various Hazardous Materials and infectious agents (Bloodborne Pathogens, or other potentially infections materials (OPIMs). Therefore, the following are also required:

• Ability to follow the established Environmental Health & Safety rules, procedures, and/or BioSafety Guidelines
• Ability to read and understand Safety Data Sheets (SDSs)
• Ability to be available and willing to work some weekends and evenings to conduct and complete experiments
• Knowledge of biosafety techniques and aseptic/gowning practices
• Experience with laboratory safety standards and procedures, including biohazard handling and disposal techniques, and the ability to ensure laboratory compliance with required safety regulations
• Experience working with biological and chemical hazards, infectious agents, bloodborne pathogens and animal allergens
• Experience working in and maintaining a sterile environment
• Experience working with chemical, and biological hazards 
• Thorough knowledge of the operation and maintenance of various lab equipment such as microscopes, centrifuges, spectrophotometers, balances, pH meters, and electrophoresis equipment, freezers, and incubators.

Occasional travel may be required, including travel between Xencor’s Monrovia and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.

Americans with Disabilities Act (ADA) Statement

The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact HR@xencor.com.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Equal Employment Opportunity (EEO) Statement

The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law.

Xencor does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor, implied or otherwise.