Sr. Director, Process Development & Manufacturing – Job #1043
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 Drug Product Development & Manufacturing to join our expanding team in Technical Operations. The scope of the position and requirements are described below.
Position Summary:
The newly created role of Sr. Director, Process Development & Manufacturing will provide leadership for clinical and commercial drug substance manufacturing within the CMO organization and will partner with internal teams for support. This person will be the technical and leadership resource for upstream and downstream development, scale up, technical transfer, clinical and commercial manufacturing, provide engineering and scientific expertise on equipment and process optimization, technical document authoring, continuous improvement, process validation, and continuous process verification. The position is also responsible for ownership of the drug substance process control strategy and providing specialized expertise in support of 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.
Primary Responsibilities:
- Provide strategic leadership, technical expertise and specialized knowledge in antibody drug substance process development and outsourced manufacturing
- Direct technology transfer to/from contract manufacturing organizations and provide technical oversight of drug substance manufacture
- Ensure routine technical support of the CMOs for deviation management, batch record reviews, and lot disposition
- Ensure that CMC life cycle strategies for products are implemented at CMOs and support regulatory submissions and approvals
- Participate in the commercial CMO selection process by evaluating CMO/supplier technical capabilities against applicable manufacturing, quality and compliance requirements
- 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 manufacturing sites globally to resolve significant quality events and manage complex change controls
- Lead development and management of department budget and long-range plans
- Serve as SME for areas of responsibility during regulatory inspections
- Review regulatory filing documents
- Work collaboratively and cross-functionally with other key leaders to ensure the proper execution of organizational goals
- Able to travel internationally (~10%)
Qualifications:
- At least 20 years of experience (17 with MS, 15 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 pre-approval, launch and post-approval stages
- Extensive experience working with Contract Manufacturers is required with overall knowledge of monoclonal antibody drug product production in a cGMP-regulated environment including US/EU regulatory and quality requirements, practices and standards
- Strong track record of developing strategies and transforming them into actionable plans, driving results and achieving expected outcomes
- Experience with start-up and validation of manufacturing equipment
- 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 matrixed teams of people
- 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#1043
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.