At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
Job description
About the Role
We are seeking a highly skilled and detail-oriented Extractables & Leachables (E&L) Specialist to join our team and play a critical role in supporting impactful pharmaceutical and biopharmaceutical projects. The ideal candidate will possess proven expertise in E&L testing, regulatory compliance, and risk assessment, with a solid background in GMP/GDP processes. This role involves managing the entire E&L lifecycle, from protocol development to risk assessments, ensuring adherence to both internal and legal requirements.
Key Responsibilities
E&L Protocol Management
Develop and manage comprehensive Extractables protocols, ensuring they align with E&L expertise, internal standards, and relevant legal requirements (e.g., USP 665, USP 1665). Ensure all protocols are fully compliant with regulatory standards and company-specific requirements for extractables testing.Procurement & Logistics
Oversee the Purchase Order (PO) process for acquiring materials to be tested, collaborating closely with manufacturers. Ensure the proper shipment of materials to external laboratories, maintaining full traceability and adhering to GMP sending checklists throughout the process.Data Management
Collect, validate, and input study results into the internal database for accurate record-keeping. Provide support to manufacturing sites and Contract Manufacturing Organizations (CMOs) in constructing equipment trains and ensuring accurate data documentation.Risk Assessment & Patient Safety
Calculate the Patient Exposure Scenario (PES) using a cumulative approach to assess potential risks from leachables. Collaborate with toxicologists to conduct thorough assessments based on PES data, ensuring compliance with Permitted Daily Exposure (PDE) limits. Draft comprehensive Leachables Risk Assessments that comply with GMP and regulatory standards, ensuring patient safety.Collaboration & Coordination
Serve as the primary liaison between external laboratories, toxicologists, and internal teams, ensuring smooth coordination of testing and data analysis. Support cross-functional teams by interpreting results and integrating findings into broader safety and compliance strategies.Required Qualifications
Education
Bachelor’s degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.Experience
Minimum of 1 year of experience in E&L validation within the pharmaceutical or biopharmaceutical industry. Proven experience in developing and managing E&L protocols and GMP documentation.Technical Skills
Strong knowledge of E&L regulations and guidelines, such as USP 665 and USP 1665. Familiarity with internal E&L requirements and validation methodologies (preferred). Proficiency in Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Experience with analytical techniques such as GC-MS, LC-MS, and other relevant methods is a plus.Soft Skills
Strong organizational and project management abilities. Excellent communication skills to effectively liaise with both internal teams and external laboratories. An analytical mindset with a keen attention to detail and problem-solving abilities.What We Offer
Competitive salary and benefits package. An opportunity to work on impactful projects in the pharmaceutical and biopharmaceutical sectors. A collaborative and innovative work environment where your contributions truly make a difference.Ready to make an impact? Apply today and join our team to help ensure the safety and quality of pharmaceutical products worldwide.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.