Position Summary: The Associate Director, Drug Product Manufacturing will manage the development, implementation, and oversight of parenteral drug product manufacturing processes at Contract Manufacturing Organizations (CMOs).
The position will collaborate with internal teams, consultants, development organizations, CMOs, and suppliers to support this key function for the organization.
Key Responsibilities Include: Execute process development strategy and timeline to ensure phase-appropriate manufacturing processes and methods.
Actively manage external development and manufacturing activities, ensuring close partnership through open and transparent communication, scientific and strategic understanding, and attention to priorities and details.
Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal teams.
Plan and organize manufacturing schedules with CMOs ensuring consistent material availability for all manufacturing activities, including adequate planning for long lead time items.
Review batch production records and written instructions to ensure cGMP compliance and maintain current quality standard.
Review deviations, investigations and CAPAs and make recommendations to Quality Assurance.
Monitor CMO performance through effective governance models.
Communicate findings, including risks and opportunities to internal stakeholders during project meetings and trigger corrective actions.
Use risk management, investigational techniques, root cause analysis and quality concepts in the identification and evaluation of compliance risks.
Facilitate the process of identifying and selecting new CMOs.
Review essential elements of scale-up and technology transfer leading to successful process validation and implementation of a robust commercial manufacturing process.
Gather knowledge as the basis for the manufacturing control strategy, the approach for process qualification and continuous process improvements.
Participate in the active writing and review of CMC modules for clinical and commercial regulatory submissions (NDA, IND, etc.).
Assist in contract negotiation and implementation of agreements.
Participate in various cross-functional projects as needed and appropriate.
Other duties as assigned.
Education, Registration & Certification: Degree in life sciences / engineering or related field.
Experience: At least 7-10 years of progressive experience in cGMP manufacturing and development of parenteral products.
Experience with late-stage drug product process development and commercialization preferred.
Experience with pre-filled syringes and/or other drug delivery devices a plus.
The ideal candidate has passion for learning, creating, problem solving, communicating, and working in cross-functional teams.
Physical Demands and Work Environment: This is largely a sedentary role; however, some filing is required.
This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.
This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Travel Requirements: Will work from the Company’s San Francisco Bay Area office, with additional travel as required to oversee the virtual development and manufacturing network (estimated at 25%).
Benefits and Perks: Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long
– term disability insurance, life insurance and more Visit https://apellis.com/careers/ to learn more.
Company Background: At Apellis, we are committed to developing transformative therapies for people living with a broad range of debilitating diseases by controlling complement, part of the body’s immune system.
Our work is rooted centrally at C3, which is the only target in the complement cascade that addresses all three pathways that can drive disease.
Targeting C3 has broad platform potential to treat many diseases where patients have few or no treatment options available.
Our programs across ophthalmology, nephrology, hematology, and neurology are further exploring what is possible by targeting C3.
Visit https://apellis.com/about-us/ut.html to learn more.
EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws.
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, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.
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.