Director, Commercial Manufacturing – Job #1037
Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.
The company is seeking to recruit a Director of Commercial Manufacturing to join our expanding team in Technical Operations. The scope of the position and requirements are described below.
The newly created role of Director, Commercial Manufacturing will provide leadership for all of the commercial production within the CMO organization, namely Biologics Drug Substance and Sterile Drug Product, and will partner with internal development and supply operations teams for technical support. This person will be the technical and leadership resource for commercial manufacturing, purposed to provide engineering and scientific expertise on equipment and process optimization, technical document authoring, continuous improvement, equipment, and process quality system ownership, process validation, and continuous process verification. The position is also responsible for ownership of the commercial process control strategy and providing specialized expertise in support of commercial manufacturing-related critical investigations and change control activities. This person will report directly to the Vice President of Technical Operations and will be based in Redwood City.
- Build newly formed Commercial Manufacturing function establishing clear team identity, roles and responsibilities and hand off’s with other functions
- Ensure routine technical support of the CMOs for deviation management, batch record reviews, and lot disposition
- Lead development and management of commercial manufacturing budget and long-range plans
- Ensure that CMC life cycle strategies for products are implemented at CMOs and support regulatory submissions and approvals
- Lead the commercial CMO selection process by evaluating CMO/supplier technical capabilities against applicable manufacturing, quality and compliance requirements
- Develop mitigation plans for significant technical risks at CMOs and key raw material suppliers
- Develop risk-based strategies for the CMO technical oversight, taking into account the product life cycle, technical complexity and CMO capabilities
- Develop process and product monitoring plans, master data and documentation management, compliance to Allakos quality systems, and other operational readiness support activities
- Provide assistance to sites globally to resolve significant quality events and manage complex change controls
- Take ownership of all commercial process-based quality systems, including change controls, deviations, and CAPAs. Work with Biologics Development and Clinical Manufacturing team, Site Managers, and QA to properly manage quality system investigation and closure
- Able to travel ~ 20% of the time
Qualifications & Expertise:
- At least 15 years of experience (12+ with MS, 10+ for PhD) successfully working in an operations environment, with at least 8 years managing cross functional projects
- Experience in product/process CMC life cycle management including prre-approval, launch and post-approval stages
- Extensive experience working with Contract Manufacturers is required with overall knowledge of monoclonal antibody drug substance and drug product production in a cGMP-regulated environment including US/EU regulatory and quality requirements, practices and standards
- Experience with start up and validation of manufacturing equipment
- Strong track record of developing strategies and transforming them into actionable plans, driving results and achieving expected outcomes
- Strong leadership skills and ability to influence at all levels
- Excellent written and verbal communication skills. Ability to convey complex technical issues to diverse audiences including internal teams, external partners and health authorities
- Experience in technical supervision, coaching and mentoring or leading small matrixed teams of people or scientific projects
- Exceptional interpersonal skills to establish positive relationships with internal stakeholders, CMOs, and multi-functional/multi-cultural teams
The salary is competitive and commensurate with experience and qualifications. Interested applicants please send resume to CMCcareers@allakos.com and reference Job#1037
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.