Senior Scientist - Analytical Development and Validation

Analytical Development (AD) department cover the key area of activities on Analytical Method development, transfer, and validation. These analytical methods are used for product characterization, release testing and stability testing of biopharmaceuticals (proteins, MAbs, vaccines, ATMPs). The purpose of Senior Scientist, Analytical Development and Validation is to be the analytical methods validation expert and to act as an analytical project lead.

Your tasks

Scientific

• Responsible for analytical methods transfer, development, phase-specific qualification, validation, and implementation of pharmacopeial methods.
• Acts as the go-to-person in the company for analytical methods validation related matters.
• Contributes on strategies and policies related to analytical methods transfer, development, validation, and implementation for QC testing.
• Tracks scientific breakthrough / developments in the field of analytical methods development and validation. Implements up-to-date knowledge and guidelines into internal procedure, practice, and capacity expansion.
• Writes and/or reviews protocols, reports, policies, SOPs, and other Quality documents.

Project management and execution support

• Acts as the Analytical Project Lead to the to the project team.
• Provides input on project planning and execution according to client requests, internal capabilities, and resource availability.
• Ensures analytical updates on projects with the right content to external clients and internal stakeholders.
• Provides tactical and analytical content inputs to overall CMC development strategy and new business proposals.

You have

• Holds a Ph.D. in (bio)analytical or relevant field with 5+ years of work experience on analytical methods validation in biopharmaceuticals industry or M.Sc. with 10+ years of industry experience.
• Possesses high level of expertise on analytical methods validation, QC method establishment, biologics product characterization, reference standard qualification, and analytical comparability study.
• Has deep understanding of ICH Q14, ICH Q2, ICH Q6A-Q6B guidelines and pharmacopeia. Has broad knowledge of CMC Development trajectory and quality-by-design (QbD), especially quality target product profile (qTPP) and bill of testing (BoT).
• Possesses expertise on most of the following analytical methods: ELISA, U/HPLC, CE-SDS, cIEF, (q/RT/dd/d) PCR, cell-based bioactivity/potency methods, enzymatic assays, and spectrometry.
• Trained on pharmaceuticals quality management system (QMS), Good documentation practice, Data integrity, and Quality risk management.
• Excellent writer and reviewer of scientific reports and Quality documents.

Who are we looking for?

• Professional self-development
• Result oriented
• Accountability
• Cooperation
• Communication
• Technical savvy

Our offer

• You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
• A culture that is characterized by entrepreneurial spirit and close and transparent communication. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
• You will be working in our dynamic headquarters in Leiden.
• Being part of a company that is focused on excellence in GMP Manufacturing.
• A competitive salary that matches your responsibilities and experience.

Your application

We look forward to hearing from you! We are interested in your CV, but we also want to find out more about your ambitions, your personality and what drives you to apply. So be sure to include a brief cover letter telling us why you are a match for this position. The application process consists of an introduction by the Recruiter, two interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist followed by contract negotiations. Depending on the vacancy, an assessment could be part of the process.

Important notice to search firms and recruitment agencies

HALIX does not accept unsolicited approaches from recruitment agencies and/or search firms (such as, for instance, the sending of resumes) for any job posted on this or a referring website. All recruitment agencies and search firms are required to contact HALIX Recruitment via [email protected] to enquire about a potential recruitment or search agreement with HALIX.

HALIX, the healthcare CDMO

HALIX is a fast growing, biopharmaceutical contract development and manufacturing organization (CDMO) focused on viral vector and recombinant protein products. We support our customers with the development & commercialization of biologics enabling the treatment & prevention of life threatening conditions such as cancer, COVID-19, influenza and other infectious diseases. Our state of the art GMP manufacturing facilities and our experienced and dedicated team of people ensures manufacturing capabilities which meet the highest quality standards, a service oriented way of working and a flexible mindset. If you too would like to become part of an innovative and challenging contract development and manufacturing organization (CDMO), then this is a perfect opportunity!

HALIX is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HALIX is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.