Analytical Methods Development & Validation Expert - Biologics

VIDA Connected Specialists; Berlin; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading biotechnology firm based in Berlin is seeking an Analytical Methods Development & Validation Expert with over 7 years of experience in a regulated environment. The ideal candidate will drive analytical method development, manage qualification processes, and ensure regulatory compliance. Strong expertise in HPLC and ELISA, along with a postgraduate degree in relevant sciences, is required. Ability to work in a fast-paced environment is essential.

Qualifikationen

• 7+ years of method validation experience in an FDA- or EMA-regulated industry.
• 2+ years of experience in a cGMP Quality Control environment.
• Hands-on lab experience with bioanalytical methods.

Aufgaben

• Support analytical method qualification and validation.
• Monitor release and stability testing for product quality.
• Act as technical reviewer for data sets and protocols.
• Author technical reports in compliance with regulatory requirements.

Kenntnisse

Method validation

Analytical transfers

Laboratory investigations

Communication

Regulatory compliance

Ausbildung

Postgraduate degree in chemistry/biochemistry/life sciences/engineering

Tools

HPLC

ELISA

CE

LC-MS

PCR

Jobbeschreibung

We have partnered with our outstanding client, Immutep, to find an Analytical Methods Development & Validation Expert.

Immutep is an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany, and France, Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and NASDAQ.

Location :

Berlin, Germany; office-based, 75-100 % negotiable or remote with 10% presence in the Berlin office

Summary :

Due to continuous progress in their projects, Immutep is expanding its team and seeking a Bioanalytical seasoned expert for Biologics. You will work within the manufacturing team of Immutep to support the analytical-related activities required to ensure successful process characterization (PC) & validation (PV) and deep product characterization of Immutep’s lead candidate, eftilagimod alpha, as they advance towards commercialization.

This is a conceptual and office-based role, where the candidate will be responsible for the oversight and management of the method fit-for-purpose assessment, qualification, and validation to support PC / PV operations at their Contract Development and Manufacturing Organization (CDMO). This implies the support of national and international projects under consideration of applicable local laws, international guidelines (ICH, cGMP, PIC / S), and project-specific SOPs for a late-stage project.

The position requires expertise with the following techniques, including, but not limited to, compendial methods and non-compendial HPLC, ELISA, CE, cIEF, LC-MS, real-time PCR, spectrophotometry, SDS-PAGE, and cell-based assays, as well as other technologies suitable for the assessment of recombinant protein-based biopharmaceuticals. The ability to function in a fast-paced, highly technical environment and communicate effectively is essential for success in this role.

Job description :

• Supporting and driving analytical method fit-for-purpose, equivalency, qualification & validation, and method transfer activities to support process characterization and validation of commercial scale manufacturing process of biologics, especially antibodies and fusion proteins.
• Supporting and driving product and standards characterization, as well as impurity characterization.
• Monitoring release and stability testing to ensure data integrity, regulatory compliance, product quality, on-time completion, and performing statistical analysis for shelf-life extension.
• Acting as the technical reviewer of data sets, SOPs, protocols, reports, quality records, and lab investigations generated by CDMO testing labs.
• Authoring CoAs, technical reports, internal quality records, and investigations in accordance with regulatory requirements.
• Supporting data trending, interpretation, and statistical analysis of commercial release and stability studies.
• Monitoring product-specific reference standard programs in collaboration with the CDMO testing labs to sustain routine testing activities, including driving efforts for reference standard qualification, annual re-qualification, and distribution to contract test labs.
• Serving as the SME for product-specific test methods for quality control.
• Leading and facilitating interactions with CDMO.
• Collaborating frequently with internal cross-functional groups to provide status updates, workflows, and timelines for analytical-related activities.
• Preparation of document package fulfilling the requirements of BLA / MA.
• Participate in management reviews of process performance, product quality, and the quality management system.
• Assist with regulatory submission preparations and response to queries.
• Provide requested input on the forecast of annual budgets.
• Provide requested input to Product Development Plans and Portfolio Review.
• Represent the Company at external conferences and meetings.

Skills / Experiences / Qualifications :

Postgraduate degree in chemistry / biochemistry / life sciences / engineering background.

7+ years of method validation, analytical transfers, or laboratory investigation experience in an FDA- or EMA-regulated industry, supporting BLA / MAAs.

2+ years of pharmaceutical / biotech working experience in a cGMP Quality Control.

Hands-on experience within a bioanalytical lab, familiarity with equipment and test methods, which may include HPLC, CE, cIEF, PCR, ELISA, gel-based assays, and other compendial assays used to test biopharmaceuticals.

Hands-on experience of writing and or reviewing GxP documents (including SOP’s, qualification / validation plans / reports, batch records).

Thorough understanding of principles, practices, and standards for biopharmaceutical testing.

The candidate must be located in Europe and must have experience working with recombinant proteins such as Monoclonal antibodies, FC-Fusion proteins.

Please contact [e-mail] with a CV for more information.