Associate Director - Director, Drug Product Development & Manufacturing - Remegen Biosciences, Inc.

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 the novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for the patients with significant unmet medical needs. RemeGen Bioscience is a wholly owned subsidiary of RemeGen Co., Ltd., a global pharmaceutical company specialized in autoimmune, oncology, and ophthalmic diseases.

POSITION
RemeGen Biosciences is seeking a highly skilled and motivated Engineer/Scientist with a strong background in final drug product (FDP) development and manufacturing in the biopharmaceutical industry. This role works with the Commercial Development and Readiness team; enables commercial and clinical supply for RemeGen’s late-stage programs. The applicant should have strong communication and collaboration skills, along with multiple examples of strong technical background in combination products development. 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 implement appropriate controls to ensure robust clinical/commercial manufacturing at external manufacturing facilities. We seek applicants that 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 Packaging Process Validation, Packaging and Device Components Qualifications, upcoming Commercial Support, Process Monitoring, Deviations/CAPA’s and Close Collaboration with Drug Product Manufacturing and Combination Products Development team. Multi-day and/or international travel (up to 15%) may be expected to lead process validation, technology transfer and provide Person-in-Plant support for clinical/commercial batches.

KEY RESPONSIBILITIES

• Manage RemeGen's CMO site(s) for combination products manufacturing, specifically labeling, assembly and packaging of final drug products.
• Work with cross-functional teams in identification and selection of combination products CMO
• Build processes and strong relationships with external manufacturing organizations.
• Develop manufacturing schedules with the CMO by working with Supply Chain and CMC team to enable 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.
• 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 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.
• 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. Furthermore, work with internal and external teams in issue resolution and serve as an escalation agent.
• 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 combination products manufacturing during CMO batch record review with Quality Assurance. Assist with the resolution of deviations and facilitate the batch disposition process with Quality Assurance.
• 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 and facility changes at CMO.
• Participate in GMP compliance audits of RemeGen CMO sites for combination products 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.

In addition, work with your manager and cross-functional teams at RemeGen China location, leading relevant activities where you are the SME or have extensive knowledge (i.e., device assembly, packaging processes and design controls of combination products such as PFS and Autoinjector).

REQUIREMENTS
 

Education:	Bachelor’s or advanced degree in pharmaceutical sciences, biochemistry, chemical engineering, or a related field & 10 years of directly related experience.
Experience:	10 years of experience in drug product development & manufacturing within the pharmaceutical or biopharmaceutical industries. Preference: experience in Design Control Processes & Combination Products Development  and Manufacturing. Experience in managing CMOs, from selection to contracts negotiation, audits, & ongoing performance monitoring. Extensive knowledge of drug product manufacturing processes, especially assembly-labeling-packaging processes), characterization, tech transfer, and validation activities. Validation experience on packaging process and equipment validation with focus on combination products. Experience authoring and reviewing manufacturing documentation, including protocols, batch records, and SOPs. Process Validation/Qualification principles, and industry best practices. Strong understanding of regulatory and quality requirements; and, guidelines related to drug manufacturing, including IND, CTA, BLA, & MAA submissions.
Skills:	Strong team player with good collaborative and people skills. 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. Working knowledge of relevant FDA, EU, ICH guidelines and GMP regulations. 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 remotely or in the office. Exempt employees are occasionally called to work outside of their normal daily schedule. Requires up to 15% travel as needed.

COMPENSATION & BENEFITS
 

Salary Range:	$160,000 - $240,000
Benefits:	401(k) and matching program Medical, Vision, and Dental Insurance Flexible Spending Account Short- and long-term disability Life insurance Employee Assistance Program Employee discounts Paid time off/vacation/sick time Professional development assistance Referral program

RemeGen Biosciences is an Equal Opportunity Employer. RemeGen Biosciences’ success depends heavily on the effective utilization of qualified people, regardless of their race, ancestry, religion, color, sex, age, national origin, sexual orientation, gender identity and/or expression, disability, veteran’s status, or any other characteristic protected by the law. As a company, we adhere to and promote equal employment opportunity (EEO) for all.

Must be able to work legally in the United States without sponsorship from employer.
 

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