Senior CMC Project Manager – Job #1012
The Senior Project Manager is responsible for providing chemistry, manufacturing and control (CMC) project management for Allakos’ novel therapeutic antibody in late stage development through commercialization. This individual is a member of the Technical Operations team and is expected to support project and resource planning as it relates to timelines, manufacturing scheduling, and supply chain. This person will engage with key functions within Technical Operations, Regulatory, QA, Commercial and Finance and where appropriate, third party vendors to drive project productivity and timelines. This position requires working knowledge of monoclonal antibody development and cGMP manufacturing principles and practices. The successful candidate shall be an experienced technical project manager with a proven track record for delivering in a fast-paced, multi-disciplinary, and collaborative work environment. This position reports to the Associate Director, CMC Project Management.
- Manages and maintains business relationship with contract manufacturing organizations
- In partnership with the CMC project team lead collaborates with the team to ensure continuity of supply for clinical studies and resolves issues and organizes team to execute on the corrective actions
- Develops and manages detailed project timelines for CMC activities
- Monitors project execution and adjusts plans
- Facilitates cross functional evaluation and endorsement of proposed changes and tracks approved changes through to completion
- Facilitates project communications, documentation, reporting and development of presentations to Technical Operations and Senior Leadership
- Works closely with all teams within Technical Operations, including, cell culture, purification, formulation, fill/finish, analytical, Quality control and supply chain and logistics.
- Escalates issues/risks to Sr. Management in a timely manner
Qualifications & Expertise:
- BA/BS Degree in a relevant science discipline; with a minimum of 8 years of experience in drug development within the pharmaceutical industry.
- In depth knowledge of project management as a discipline including the ability to create, coordinate, and maintain an integrated project plan and to control or respond to changes in strategy and scope
- 5+ years of experience working with contract manufacturing organizations and leading cross-functional biologics project team
- Strong communication and negotiation skills. Excellent interpersonal skills.
- Ability to interact with multiple layers of the organization with demonstrated success initiating change and influencing at all levels
- Proactive, forward-thinking and creative with high ethical standards and a team player with leadership skills and ability to influence others to achieve successful outcomes and meet timelines
- Familiarity with domestic and international cGMP regulations and industrial guidance documents (CFRs, ICH)
- Self-motivated and willing to accept responsibilities outside of initial job description
- Ability to handle multiple project and priorities with exceptional organizational, attention to detail and time management skills
- In-depth knowledge and skill with Microsoft Project, Excel, PowerPoint, Word, Visio and other reporting/tracking tools
- Ability to travel, domestic and international
The salary is competitive and commensurate with experience and qualifications.
Interested applicants please send resume to CMCcareers@allakos.com and reference Job #1012
Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.