Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have a very deep drug development pipeline including five programs currently in clinical testing with three more expected to start clinical testing by 1H2019 and have an excellent opportunity for a Manager/Sr. Manager to join our team. We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and have the potential to be more potent, safer and longer lasting – with the goal of improving patient outcomes and quality of life. In addition to generating a pipeline of novel drug candidates, with eleven in clinical testing by Xencor or our partners, our XmAb® technology has enabled multiple collaborations with leading biopharmaceutical companies including Novartis, Amgen, Morphosys, CSL, Janssen(J&J), Alexion and Boehringer Ingelheim.
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.
We seek a Manager/Sr. Manager, CMC Program Management to be responsible for project planning/management with a focus on CMC/Manufacturing Operations. Project oversight will include creating/managing timelines, reviewing budgets, reviewing/approving various documentation including: manufacturing batch records, SOPs, Technical Reports, investigations, and CMC regulatory content in support of product development at Xencor.
This Manager/Senior Manager position presents an opportunity for a qualified candidate to further enhance their leadership skills, demonstrate proficiency in project management and versatility and cultivate their overall understanding of Xencor’s business.
This position interacts with multiple levels of the organization. Candidate must have the ability to approach issues from a strategic perspective and demonstrate strong leadership skills, business acumen, communication/presentation skills, and the ability to influence others. This includes the ability to effectively drive both internal and external (virtual) teams, through active management of multiple client relationships supporting various components of the product supply chain.
• Support/manage high-priority and highly-visible CMC regulatory and manufacturing operations
• Author appropriate CMC sections for regulatory submissions and tracking manufacture changes
• Support CMC manufacturing documentation review (i.e. reviewing/approving manufacturing batch records, investigations, SOPs, Technical Reports, etc.)
• Participate in establishing, administering and improving department policies and procedures
• Develop and distribute periodic reports on performance, issues, risks, and schedules of key activities, events, or milestones
• Ensure risk assessments and appropriate risk mitigation plans are established for Drug Substance and Drug Product at each stage of program life cycle
• Track, monitor, and report performance metrics related to operations, quality, cost and customer service
• Ensure uninterrupted drug supply to patients/clinics via supply chain experience
• Ability to work in high pace and fast changing environment while delivering high quality and timely deliverables
• Assist Program Management and Manufacturing lead in identifying, creating, and sustaining product development processes to successfully support the growing pipeline of product candidates
• Manage cross functional teams (internal and external) to achieve strategic and desired outcomes
• Minimum of Bachelor’s degree in relevant Science or Engineering Discipline with 8 years’ experience or Master’s degree in relevant Science or Engineering Discipline with 6 years of experience.
• Minimum of 5 years’ experience in biotechnology or pharmaceutical industry including contract manufacturing, quality or engineering experience, Process Development, or other related functional experience within the Pharmaceutical/Biotech or Healthcare industry
• Proficient understanding of Regulatory requirements for clinical stage programs
• 2+ years in authoring CMC sections for regulatory documents (IND, IMPD, CTA, BLA/NDA)
• Business knowledge of Biotechnology/Pharmaceutical manufacturing operations, product and process development and supply chain operations
• Proven collaboration management, decision making skills and goal-orientation
• Experience in leading complex projects (preferably with pharmaceutical background), ideally PM certified acc. PMI or IPMA
• Experience working with contract manufacturer including person-in-plant is a plus
• Demonstrated ability to forge and maintain strong relationships with internal staff and external parties
• Strong leadership skills with ability to tactfully and effectively negotiate and influence
• Ability to communicate and present ideas to all levels of staff and management
• Capable of supporting/managing several projects simultaneously and prioritizing individual and team efforts accordingly
• Be a team player and self-starter who is capable of growth and increased responsibility
• Detail oriented and good analytical problem-solving skills
• Proficiency in MS office suite including Excel, Power Point, and Project
• Advanced degree in Science or Engineering
• 2+ years’ experience as a CMC Project Manager
• Certified as Project Management Professional (PMP) a plus