Sr. Manager, Drug Product

Sr. Manager, Drug Product

Introduction:

Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit www.xencor.com. We have an excellent opportunity for a Sr. Manager, Drug Product to join our team.

This position will be based out of our San Diego, CA. location and is a hybrid position with 2 days a week on-site.

Summary:

Responsible for providing technical insight and project planning/management of drug product development, including Person-in-Plant responsibilities.  

Job Duties:

• Provides technical expertise in formulation development screening to support a variety of dosage applications (IV, subcutaneous, continuous infusion), clinical in-use studies to support clinical product portfolio, and QbD and PPQ evaluation activities to support later phase clinical-to-commercial programs.
• Provides project oversight including creating/managing timelines, reviewing budgets, and reviewing and approving various documentation activities including manufacturing batch records, SOPs, Technical Reports, and Deviations. 
• Contributes to authoring and reviewing CMC regulatory content in support of future and existing filings.
• Manages and provide technical input to support early to late phase drug product manufacturing activities at external CMOs. 
• Develops biopharmaceutical drug product formulation screening and clinical in-use studies to support clinical product portfolio.
• Serves as CMC project(s) contact and manage cross functional interactions (internal and external) to achieve desired outcomes.
• Provides CMC manufacturing documentation review (i.e., reviewing/approving manufacturing batch records, investigations, SOPs, Technical Reports).
• Authors appropriate CMC sections for regulatory submissions (US, EU, ROW) including tracking of manufacturing changes.
• Supports future DP Manufacturing Quality by Design (QbD) and Product Performance Qualification (PPQ) activities for late phase to commercial programs.
• Manages contracts, including negotiations for technology transfer, manufacturing, and supply agreements.
• Manages and track periodic reports on performance, issues, risks, and schedules of key activities, events, or milestones.
• Works collaboratively and transparently with CMC Operations, Clinical Operations, Quality Assurance, Regulatory Affairs, and Program Management.
• Delivers high-quality and timely deliverables via the use of appropriate PM tools and methodologies.

• Adheres to all department and company-wide policies regarding conduct, performance and procedures
• Performs other duties as required.

Education/Experience/Skills:

Position requires a Bachelor’s degree in a relevant Science or Engineering discipline and at least 8 years of related experience; a Masters degree and 6 years of experience is preferred.  A minimum of 5 years of experience in biotechnology or pharmaceutical industry including contract manufacturing, quality or engineering experience, Process Development, or other related functional experience and experience as a CMC project lead working with or

for a Contract Manufacturing Organization (CMO) also required.  Requires experience authoring CMC sections for regulatory documents (IND, IMPD, BLA/NDA).  Prior experience as a CMC project lead working with or for a Contract Manufacturing Organization (CMO) and working in DP Manufacturing Quality by Design (QbD) and Process Performance Qualification (PPQ) activities to support late phase to commercial programs are preferred

Position also requires:

• Business knowledge of Biotechnology/Pharmaceutical manufacturing operations, product and process development and supply chain operations
• Strong management skills with ability to tactfully and effectively negotiate and influence
• Demonstrated interpersonal skills to develop and maintain effective working relationships with internal and external stakeholders as well as cross-functional, cross-cultural project teams 
• Ability to manage multiple complex projects while prioritizing individual and team efforts accordingly

Strong attention to detail and analytical problem-solving skills. Proficiency in basic project management methodology and tools. Proficiency in MS office suite including Excel, Power Point, and Project. Proficient understanding of CMC regulatory requirements for US, EU, and ROW for clinical and commercial products preferred. Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model

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.

Occasional travel may be required, including travel between Xencor’s Pasadena and San Diego offices. Additional travel (domestic and/or international) for scientific conferences and/or other meetings with collaborators is possible. Otherwise, work for this position is generally performed at Xencor’s worksite and requires full-time commitment.

Expected Base Salary Range:  $144,600 - $165,500

The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits.  In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/.

Xencor requires all employees to be fully vaccinated against COVID-19 as a condition of employment.  Being fully vaccinated means that at least two weeks have passed since an individual’s final dose of an authorized COVID-19 vaccine regimen.  New employees will be required to provide proof of their COVID-19 vaccination status as of their start date unless an exemption or accommodation is approved.

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.