External Manufacturing Manager Drug Substance

1 month ago

Ireland RPMGlobal Full time

External Manufacturing Manager Drug Substance Location Ireland Requisition ID 2225 # of openings 1

External Manufacturing Manager Drug Substance

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.

Position Summary

· The Amicus Drug Substance Manager, with responsibility for Drug Substance Contract Manufacturing Organization (CMO) management, plays a pivotal role in overseeing and managing all aspects of drug substance manufacturing operations. This role requires a strategic leader with a strong background in biopharma/pharma manufacturing, regulatory compliance, and quality focus.

Roles and Responsibilities:

· Lead and manage drug substance manufacturing activities, ensuring adherence to production schedules, quality standards, and regulatory requirements.

· Manage Deviations, Change Controls and CAPAs in collaboration with CMO to close in a timely manner. Collaborate closely with Amicus quality to ensure batch release plans are executed successfully.

· Implement and refine manufacturing processes to enhance efficiency, reduce costs, and optimize production output while maintaining highest-quality standards.

· Ensure strict adherence to regulatory guidelines (e.g., FDA, EMA, MHRA) and Good Manufacturing Practices (GMP) throughout the product manufacturing lifecycle.

· Serve as a point of contact for CMO, collaborating closely to understand their constraints, address concerns, and ensure successful execution of manufacturing plans.

· Identify and mitigate risks associated with manufacturing operations, proactively implementing strategies to prevent deviations and ensure continuous improvement.

· Drive initiatives for process optimization, technology implementation and best practices to improve manufacturing operations.

· Maintain accurate documentation of manufacturing activities, manufacturing batch records (MBRs), generate reports on key performance metrics, and provide regular updates to stakeholders.

· Foster strong relationships with internal and external stakeholders, ensuring alignment of manufacturing strategies with CMO and organizational goals.

Requirements

Educational Requirements

· Bachelor's or Master’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related field.

Professional Work Experience Requirements

· 5+ years experience in pharmaceutical and/or biopharmaceutical manufacturing of drug substance, with a strong understanding of GMP and regulatory compliance.

· Preferably biologics drug substance manufacturing experience.

· Excellent communication, negotiation, and CMO management abilities.

· Strong problem-solving skills and a proactive approach to driving continuous improvement in manufacturing processes.

Experience and Skills

· External manufacturing oversight and experience working with CMOs

· On the floor experience in biologics manufacturing with experience in writing, reviewing, and performing root cause analysis for deviation investigations.

· Navigating change control review and approval process.

· CAPA implementation and CAPA effectiveness review.

· Experience with continuous manufacturing; upstream and downstream.

· SME for upstream cell culture and downstream purification.

· Knowledge of batch record development and management for drug substance manufacturing.

· Problem-solving and troubleshooting skills.

· Ability to work independently or as part of a team.

· Strong verbal, written communication skills and strong interpersonal skills.

· Knowledge of lean manufacturing principles.

· Experience working in collaboration with CMO’s

· Hands on cell culture experience with cGMP commercial manufacturing

· Familiarity with perfusion bioreactor systems coupled with ATF and other harvesting technologies, Unicorn chromatography control system and Delta V.

· Knowledge of cGMP manufacturing of recombinant enzymes.

Other skills/Attributes

· Demonstrated alignment with Amicus Mission Focus Behaviors.

· Passion for rare disease and patient focused.

Location

· Ireland or UK.

Travel

· Travel to CMO’s may be required to meet business needs. Approx. 10% travel.

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law

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