Vice President, Biologics Process and Analytical Sciences

Vice President, Biologics Process and Analytical Sciences   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.   Position Summary:   Allakos Inc is seeking a highly motivated Vice President of Biologics Process and Analytical Sciences. This person will report to the Sr. Vice President of CMC Technical Operations and provide leadership, strategy, and management skills to oversee, lead and further expand the process and analytical development of company’s proprietary programs through preclinical, clinical, and commercial stages. The ideal candidate will be a seasoned pharma/biotech leader with an outstanding record of accomplishment in clinical/commercial manufacturing of biologics, quality control, process development, formulations, analytical development, and new site build out. They will also have experience in the global submission and maintenance of CMC sections of regulatory (IND, BLA) filings. Candidates will have previously worked in a detailed manner on biologics CMC development programs that have been filed and approved for registration with the FDA and other global regulatory bodies.   Your Role:

• Translate the corporate strategy into supportive strategies for global pharmaceutical manufacturing, process development, analytical development, quality control, technology transfer and validation from early-mid stage product development through global manufacturing for commercial products.
• Oversee and provide technical leadership, strategic direction, risk assessment, and oversight for successful long-range planning and execution across all supporting functions.
• Ensure new site build out meets designated timeframes, budgets, and development capabilities.
• Lead an analytical development team responsible for stage appropriate analytics in support of processes and product releases
• Responsible for successful technology transfers of processes and analytical methods to CRO’s, CTO’s and internal QC functions, and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards.
• Prepare, review, or edit cGMP batch records, CMC regulatory, and quality documents.
• Lead teams of scientists and researchers to deliver a sustainable pipeline from inception, through IND and BLA submissions.  Oversee all process and analytical development components of manufacturing process that are robust and scalable
• Lead CMC regulatory efforts, including authoring and organization of CMC sections of BLA’s.
• Ensure product demands are being met utilizing both internal development capabilities as well as CROs and CMO’s. Execute plans in accordance with cGMP, ICH and FDA regulations.

Qualifications and Expertise:

• 20+ years of experience in a pharmaceutical or biotechnology environment overseeing CMC teams in all stages from pre-clinical to commercialization. PhD/MS in science (e.g., biochemistry, chemistry, pharmaceutical sciences, or related discipline)
• Experience overseeing the development of biologic therapeutics. Proven leadership and cross-functional management of multiple CMC programs. Track record of successfully driving and managing programs, overcoming challenges and risks
• Operational interactions with global regulatory bodies including FDA, EMEA, PMDA and SFDA.
• Established network and experience working with CRO’s and CMO’s.
• Strong leadership skills with proven ability to work collaboratively internally and externally, with the ability to manage multiple stakeholders.
• Strong technical judgment with attention to detail.
• Strong oral and written communication skills.
• Strong organizational skills.
• Highly skilled to proactively identify and manage potential risks.

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.