Associate Director, Packaging Contract Mfg. Site Management – Job #1028
As a member of the CMC Supply Operations Management team within Technical Operations at Allakos, this person will be accountable for overseeing all aspects of key initiatives and projects in the company's secondary packaging contract manufacturing network. As the Packaging Contract Manufacturing Site Manager, lead cross-functional teams and support the processes and systems to ensure exceptional quality and provide reliability throughout the secondary packaging network. This includes developing a CMO strategy, managing the business relationship, ensuring the successful supply of product and achieving operational and business goals. They will lead the AK002 finished good product changes, investigations, process improvement and risk mitigations. They will also lead all Allakos Serialization activities from a business perspective. This position reports to the Exec. Director of CMC Supply Operations.
Responsibilities
- Lead process to select and contract with CMOs for secondary packaging and serialization
- Lead project to develop and implement commercial packaging & serialization processes at the CMOs
- Business owner for Allakos Serialization system accountable to select an IT solution, develop related business processes and implement including integration with CMO & 3PL systems.
- Accountable for secondary packaging and label / artwork design based on requirements from Commercial, Regulatory, Quality and Technical stakeholders.
- Lead efforts to implement the package / labeling design and perform shipping validation, working with CMOs, component suppliers and related design service providers.
- Accountable for the daily management of commercial packaging and serialization at designated manufacturing locations.
- Monitor the evolution of Health Authority serialization requirements and serialization technology and develop a road map to advance Allakos capabilities in this space as needed
- Provide leadership, management, and instruction to external manufacturing sites to ensure the company's clinical / commercial supply and operational / project goals are met promptly and exceptionally.
- Finished Good CMO partner for company within the CMC Supply Operations group.
- Responsible for organizing and leading the company's cross-functional teams which work with the CMOs including Quality, Regulatory, Finance, Technical Operations, Legal, Clinical, Commercial and Business Development.
- Ensures the CMO executes the production plan to deliver an uninterrupted supply of commercial product. Identifies supply constraints and leads timely resolution of issues. Monitors production campaigns and reports on CMO’s performance against plans, including negotiation of improvement plans for adverse trend performance.
- Facilitates the identification, prioritization, planning and execution of a broad range of medium to complex technical projects. Ensures successful and timely completion of deliverables. Owns planning and execution of technical changes that have regulatory and/or multi-site impact.
- Ensures CMO project plans are aligned with overall Allakos plans for regulatory filings and other key initiatives.
- Ensures that corporate safety, health and environment (SHE) and Quality audits are performed, and mitigations plans are in place for the CMO to comply with terms of agreements, corporate group policy and local legal requirements.
- Reviews commercial supply and quality agreements. Forecasts CMO budget and gains approval. Controls cost to ensure the CMO Site is within approval budget.
- Travel domestically and internationally up to 10% 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 working with Contract Manufacturers is required with overall knowledge of secondary packaging and serialization in a cGMP regulated environment.
- Previous experience in technology, quality and/or supply chain roles is preferred.
- Previous experience in secondary packaging / label design is preferred
- Previous experience in shipping validation is preferred
- Certification in Project Management (i.e. PMI certification) or additional relevant management training is preferred.
- Previously worked with cGMP-regulated environment including US/EU regulatory and quality requirements, practices, and standards.
- Exceptional interpersonal skills to establish positive relationships with internal stakeholders, CROs/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#1028
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.