Title:	Director, Drug Product Development & Manufacturing	FLSA Status:	Exempt
Department:	Drug Manufacturing & Supply Management	Role Designation:	Remote
Reports To:	VP, Drug Manufacturing & Supply Management	Schedule:	Regular Business Hours Flexible Hours
Location:	South San Francisco, CA or Remote

ORGANIZATION
RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design technologies, and extensive knowledge in clinical development, our vision is to uncover novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for patients with significant unmet medical needs. RemeGen Bioscience is a wholly owned subsidiary of RemeGen Co., Ltd, a global pharmaceutical company specializing in autoimmune, oncology, and ophthalmic diseases.

POSITION SUMMARY
The position requires a highly skilled and motivated Engineer/Scientist with a strong background in drug product (DP) development and manufacturing in the biopharmaceutical industry. This role works with the Commercial Development and Readiness team and enables clinical supply for RemeGen’s late-stage clinical programs as well as commercial readiness. The applicant should have strong communication and collaboration skills, along with multiple examples of a strong technical background in drug product development. The ideal candidate should have prior demonstrated experience in supporting clinical/commercial drug product operations with a focus on effective troubleshooting, interfacing with existing teams to collaboratively resolve process investigations, and implementing appropriate controls to ensure robust clinical/commercial manufacturing at external manufacturing facilities. We seek applicants who are proactive, enthusiastic, and show a passion for their work. The position will collaborate with RemeGen's cross-functional teams across the globe, as well as external CMO teams.

In this role, you will lead and coordinate activities from delivery of frozen drug substance, to thawing and filling of the drug product, primary container components qualifications, upcoming Commercial Support, Process Monitoring, Deviations/CAPA’s and Close Collaboration with Formulation and Process Development team, Combination Products Development team, and Final Drug Product Manufacturing team. Multi-day and/or international travel (up to 15%) may be expected to lead to technology transfer, process validation, and provide Person-in-Plant support for clinical/commercial batches.

As the Director, you will be responsible for overseeing and managing the drug product process development, characterization, technology transfer, and validation activities at the Contract Manufacturing Organizations (CMOs). The position will require you to author and review manufacturing documentation, provide technical support during clinical manufacturing and commercialization activities (i.e., PPQ runs), collaborate with CMOs and internal teams on deviations and investigations, and interact with regulatory agencies for drug product-related submissions. In addition, you will be responsible for leading the effort with CMOs on PPQ strategies for drug product process validation execution, to BLA/MA submissions.
An understanding of the various functions represented within the CMO team is required to provide oversight of cross-functional activities within the CMO team, to bring about successful planning, monitoring, and executing of deliverables of the CMC program. Routine reporting of activities, issues, strategies, risks, etc., to the CMC management team is expected. The role generally involves making use of scientific expertise and understanding of the industry to develop and contribute to complex company objectives.

KEY RESPONSIBILITIES

Manage RemeGen CMO site(s) for drug product manufacturing.
Work with cross-functional teams in the identification and selection of drug products, CMOs/external manufacturing site(s)
Build processes and strong relationships with external manufacturing organizations
Develop manufacturing schedules with the CMO by working with Supply Chain and the CMC team to enable the timely manufacturing of clinical trial material for clinical studies
Develop and implement Process Performance Qualification (PPQ) strategy and post-approval process improvements with effective balance among quality, financial, and inventory risks
Drug Product Process Development and Technology Transfer: Lead the drug product process development, characterization, technology transfer, and validation activities at CMOs
Work with cross-functional teams with clear accountability for performance and ensure the quality, cost, and delivery of products from RemeGen CMO sites are consistently met. Also, work with internal and external teams in issue resolution and serve as an escalation agent
Co-ordinate meetings with CMO PM/representatives as required to enable project activity completion, capture key decisions in meeting minutes, and distribute or share with the internal CMC team during the weekly CMC team meeting
Interact with Quality Assurance, Quality Control, Manufacturing, Project Management, Finance, Supply Chain, and Process Development within RemeGen
Ensure metrics are in place to measure, track the performance of the contract sites, and lead external or internal operating review meetings related to the site(s) you manage
Represent drug products manufacturing during CMO batch record review with Quality Assurance.
Work collaboratively with CMOs and internal teams to review and address deviations and non-conformances in drug product manufacturing processes. Assist with root cause analysis and contribute to investigations. Develop risk mitigation strategies and Corrective and Preventive Actions (CAPAs) as required. Facilitate the batch disposition process with Quality Assurance
Person-in-Plant (PIP) Technical Support: Provide PIP technical support during clinical manufacturing at CMOs. Ensure smooth execution of manufacturing processes, troubleshoot any issues that arise, and facilitate effective communication between internal teams and CMOs
Lead the communications with RemeGen’s CMOs and enlist the support of the relevant CMC functions to resolve technical issues and develop implementation plans for manufacturing process changes, tech transfer, and scale-up activities. Manage and provide input on process description updates and change control requests related to equipment, process,s and facility changes at CMO
Participate in GMP compliance audits of relevant RemeGen CMO sites with RemeGen Quality Assurance
Manage budget development, monitoring and reporting; ensure cost of production targets are met; and actively oversee forecasting, capacity planning and project management
Drive risk management and operations excellence
Author and review process characterization and validation documentation, including protocols, batch records, and Standard Operating Procedures (SOPs) as required. Ensure compliance with regulatory guidelines and industry best practices
Author drug product sections in regulatory submissions such as Investigational New Drug (IND) applications, Common Technical Document (CTD), Biologics License Applications (BLA), and Marketing Authorization Applications (MAA). Interact with regulatory agencies and contribute to developing responses to questions related to drug product development, process characterization, and validation during regulatory filing and inspections

In addition, work with your manager and cross-functional teams in RemeGen Yantai and lead relevant activities where you are the SME or have extensive knowledge (i.e., formulation development, filling process development).

REQUIREMENTS

Education:	Bachelor’s or advanced degree in pharmaceutical sciences, biochemistry, chemical engineering, or a related field & 15 years of directly related experience. An advanced degree is preferred.
Experience:	15+ years of experience in drug product development and manufacturing within the pharmaceutical or biopharmaceutical industries Experience in managing CMOs, from selection through the lifecycle, including contracts. Audits and ongoing performance monitoring through to debrief and assessment Identification of project optimization opportunities (timeline, budget, technical execution) Experience providing oversight of cross-functional activities within the team, to bring about the successful planning, monitoring, and executing of deliverables Extensive knowledge of drug product process development, characterization, technology transfer, and validation activities Experience authoring and reviewing manufacturing documentation, including protocols, batch records, and SOPs Experience with parenteral drug product formulation development, characterization, testing, quality risk assessment, and CMC regulatory guidance and filings Process Validation/Qualification principles, and industry best practices Familiarity with deviation and non-conformance management, root cause analysis, and CAPA development Demonstrated experience in regulatory interactions and interactions with regulatory agencies Knowledge of Good Manufacturing Practice (GMP) regulations and industry best practices
Skills:	Strong leadership and project-management skills Strong team player with good collaborative and people skills Strong understanding of regulatory requirements and guidelines related to drug manufacturing, including IND, CTD, BLA, and MAA submissions Ability to successfully manage workload and timelines Ability to work independently and manage multiple priorities in a collaborative, diverse, and dynamic environment Ability to operate in a matrixed environment with site (internal & external), functional and executive leadership Excellent written and verbal communication skills Strong attention to detail and problem-solving skills

OTHER

Supervisory Responsibilities:	None.
Equipment To Be Used:	Laptop computer, other office equipment, and/or lab equipment.
Typical Physical Demands:	Manual dexterity sufficient to operate standard office equipment.
Working Conditions:	Works in a typical office setting on a hybrid schedule. Occasionally called upon to work hours in excess of your normal daily schedule. Travel as needed (some occasional domestic and international travel).

Director, Drug Product Development & Manufacturing

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