Technical Manufacturing Manager – Drug Product at APELLIS PHARMACEUTICALS INC

Zug, Zug, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

28 Jan, 26

Salary

0.0

Posted On

30 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Operations, Pharmaceutical Manufacturing, Combination Products, Sterilization Processes, GMP Compliance, Regulatory Compliance, Batch Record Review, Deviation Management, Change Control, Problem-Solving, Communication, Organizational Abilities, Cross-Functional Teamwork, Risk Management, Process Optimization, Continuous Improvement

Industry

Biotechnology Research

Description

Position Summary: At Apellis, we are driven by science and inspired by patients. We are looking for a skilled and proactive Technical Manufacturing Manager – Drug Product to join our Technical Operations team. This role is critical in ensuring the reliable supply of high-quality drug products through strategic oversight of our Contract Manufacturing Organizations (CMOs). You will play a key role in managing technical aspects of late-stage development and commercial manufacturing, with a strong focus on combination products and sterile processes. Key Responsibilities: As a core member of the Supplier Relationship Team (SRT), you will: Manage technical operations for drug product manufacturing, including batch release, deviation handling, and change control processes. Coordinate manufacturing schedules with CMOs to ensure timely availability of materials, especially for long lead-time items. Review batch production records and manufacturing instructions to ensure compliance with cGMP and regulatory standards. Collaborate with QA to assess deviations, investigations, CAPAs, and supplier risk mitigation strategies. Monitor and evaluate CMO performance, identifying risks and opportunities, and initiating corrective actions when needed. Apply risk management and root cause analysis to identify and address compliance risks. Drive process optimization, using data-driven insights (e.g., CPP trending) to enhance efficiency and support continuous process verification. Champion process stewardship, proactively resolving technical challenges and driving continuous improvement across manufacturing operations. Support audits and inspections, assessing manufacturing capabilities and ensuring documentation is organized and accessible. Contribute to regulatory submissions, including CMC modules for INDs and NDAs. Engage in cross-functional projects, bringing technical expertise to broader organizational initiatives. Education & Experience: A degree in life sciences, engineering, or a related field. 5+ years of experience in pharmaceutical manufacturing, with a strong background in technical operations and engineering. Proven expertise in combination products, including device assembly, labeling, packaging, and serialization. Hands-on experience with sterilization processes, including cycle report reviews and critical parameter analysis. Deep understanding of GMP, regulatory compliance, and quality systems. Strong skills in batch record review, deviation management, and change control. Excellent problem-solving, communication, and organizational abilities. Ability to work effectively in cross-functional teams and manage external partners. Must be authorized to work in Switzerland and hold a valid passport. Company Background: We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases EEO Statement: Apellis is an equal opportunity employer. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. #LI-AR1

Responsibilities

Manage technical operations for drug product manufacturing and ensure compliance with regulatory standards. Collaborate with CMOs and QA to monitor performance and drive process optimization.