Senior Manager, Drug Product Development And Manufacturing

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 pharmaceutic company specialized in autoimmune, oncology and ophthalmic diseases.

POSITION SUMMARY

As the Senior Manager, you will be responsible for overseeing and managing the Drug Product process development, characterization, technology transfer, and validation activities at Contract Manufacturing Organizations (CMOs). Your key responsibilities will include authoring and reviewing manufacturing documentation, providing technical support during clinical manufacturing, collaborating with CMOs and internal teams on deviations and investigations, and interacting with regulatory agencies for Drug Product-related submissions. This is a remote role, available to candidates in certain states in the U.S.

KEY RESPONSIBILITIES

• Drug Product Process Development and Technology Transfer: Lead the Drug Product process development, characterization, technology transfer, and validation activities at CMOs. Collaborate closely with internal and external teams to ensure successful execution of Drug Product manufacturing processes.
• Documentation Authoring and Review: 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.
• 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.
• Deviation and Non-Conformance Management: 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.
• Regulatory Interactions and Submissions: 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.

REQUIREMENTS

Education:

• Bachelor’s or advanced degree in pharmaceutical sciences, chemistry, chemical engineering, or a related field.
• Advanced degree is preferred.

Experience:

• 6+ years of experience in Drug Product Development and Manufacturing within the pharmaceutical or biotech industry.
• 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.
• 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 understanding of regulatory requirements and guidelines related to drug manufacturing, including IND, CTD, BLA, and MAA submissions.
• Ability to work independently and manage multiple priorities in a collaborative, fast-paced environment.
• Excellent written and verbal communication skills.
• Strong attention to detail and problem-solving skills.

COMPENSATION & BENEFITS

Salary Range:

$130,000 - $150,000

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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