Vice President, Lirentelimab Manufacturing Operations

Location
Redwood City, CA
Posted
Oct 06, 2021
Ref
4075858004
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract
Vice President, Lirentelimab Manufacturing Operations   Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory, and proliferative diseases.   Allakos is committed to developing innovative therapies that transform patients’ lives.  We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.   Your Role:
  • Develop and build the global cGMP manufacturing functions and capability to support lirentelimab late-stage clinical development, commercial readiness and support post approval activities.
  • Oversee all aspects of DS and DP process scale up, technology transfer and cGMP manufacturing in contract manufacturing sites and future manufacturing network expansions
  • Provide high quality forecasts and consistently meets financial commitments within areas of direct management responsibility. Proactively identify and communicate areas for operational and financial improvement within the function and the company.
  • Build, maintain and motivate a multi technology Operations Team capable of achieving all productivity targets and output requirements to service customers with product on time
  • Collaborate with Quality Assurance and Quality Control areas to plan and implement the execution of cGMP activities in manufacturing operations for late stage clinical manufacturing and commercial operations
  • Develop and manage the Manufacturing Operations budget requirements for each fiscal year.  Organize the purchase of appropriate capital items as required for projects
  • Establish the department's strategic vision and mentor the Manufacturing Operations Team towards goal achievement
  • Oversee manufacturing incidents and investigations, corrective and preventive actions and process variances and deviations. Ensure the completion of manufacturing change controls, CAPAs and close out of deviations. Oversee annual product reports and continuous process verification programs.
  • Ensure that facilities are inspection ready, including staff compliance with cGMP and all related elements
  • Develop short- and long-term goals for the manufacturing efforts in support of regulatory submissions, clinical efforts and program-driven milestones
  • Lead and direct filing activities for regulatory agencies, partnering with internal Regulatory Affairs
  • Communicate and escalate operational status regularly to Sr. Management Executives
  • Collaborate across functions to drive manufacturing excellence, share best practices and lessons learned
Qualifications and Expertise:
  • 20+ years of experience in a pharmaceutical or biotechnology environment overseeing manufacturing operations for both biologics drug substance and fill finish. Preference will be given to candidates with supply chain management experience.  
  • Recruit, retain, develop and lead Manufacturing Operations Teams.
  • Provide continuous and timely performance feedback to direct reports, including coaching on performance management and professional advancement. Provide employee recognition for accomplishments in a thoughtful and timely manner
  • Delegate work assignments to staff as appropriate, considering employee strengths and expertise to address associated tasks
  • Mentor individuals, based on individual needs, to meet current job expectations and career goals
  • Develop and lead a culture of learning, respect and employee growth.  Lead by creating a positive environment of open communication and staff development
  • Promote adaptation and flexibility in a rapidly changing environment
  • Act as a change leader through team building and influence
  • Ability to travel 10% of the time
The salary is competitive and commensurate with experience and qualifications.   The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership   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.