Job Description

Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases.

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.

Roles and 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.

Work Arrangement:

Travel Requirements:

None.


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Education:

Bachelor's Degree

Benefits and Perks:

Apellis offers a comprehensive benefits package, inclusive flexible time off, summer and winter shutdowns, paid family leave and more!

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases.



For more information, please visit http://apellis.com or follow us on LinkedIn and X .

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.