Associate Principal Scientist, Monoclonal Antibody (MAb) development and formulation

Job Description

For our Animal Health location at Boxmeer we are currently recruiting an Associate Principal Scientist Monoclonal Antibody (MAb) development and formulation.

Welcome in our team

The global Bioprocess Technology Solutions (BTS) team (~230 employees) drives and executes Bioprocess technology excellence in close alignment with their partners in R&D and Manufacturing in order to ensure robust product introductions, product transfers and a reliable product supply to customers. BTS has considerable expertise in viral cell culture, bacterial fermentation, downstream processing, purification, freeze drying and vaccine formulation. They are responsible for seed development, new product process development, validation/qualification and commercialization of our animal health large vaccine pipeline. Our global Product Development Team (~75 employees) provides process development, and process improvement of the Large Molecule (LM) vaccine portfolio covering the discovery, pre-development and development phase as well as transfer from R&D to Manufacturing.

About the role

An Associate Principal Scientist Monoclonal Antibody (MAb) development and formulation is the designated expert in MAb development and technology and will provide end-to-end support of manufacturing science, technology and production for both commercial products and pipeline products with a global scope. The position resides within the Bio-Technology Solutions (BTS) MAb Centre of Excellence group and supports process development activities of new mAb projects as well as existing manufacturing operations within our Company's Manufacturing Division. This incumbent is expected to serve as a leading scientific expert providing guidance, recommendations and judgment for strategic technical issues and decisions pertaining to Monoclonal antibody drug substance and drug product manufacturing technology within large molecule Global Animal Health Manufacturing (GAHM). This position will not have employee management responsibilities.

Primary Responsibilities

• Serve as subject matter expert for Monoclonal Antibody drug substance and drug product manufacturing technology and drug product formulation.

• Collaborate with research, process development, and manufacturing sites to support New Product Introductions and technology transfers.

• Provide technical governance to manage all technical aspects of product lifecycle management related to Monoclonal Antibody manufacturing technology.

• Build and maintain strong relationships with stakeholders to ensure effective communication of plans and issues.

• Stay updated on scientific developments and trends in Monoclonal Antibody manufacturing processes.

• Provide technical guidance and oversight to project teams for process changes, improvements, and technology transfers.

• Provide technical guidance to major investigations in their area of expertise.

• Design, perform, and lead practical research activities such as DSP and DP formulation studies.

Your profile

• Master of Science or equivalent in a technical or scientific discipline such as Biology, Bioprocess technology  or Chemical Engineering

• Preferred: PhD or advanced degree with specialization in a subject pertinent to monoclonal antibodies, vaccine/large molecule manufacturing At least 10 years of relevant work experience in the pharmaceutical, biotech, or related industry

• Commercial processes experience for monoclonal antibodies (drug substance and drug product), vaccines/large molecules/small molecules is required, either in development or in technical support

• Demonstrated problem solving, pro-active mindset, effective verbal and written communication, and people management skills.

• Strong scientific understanding of monoclonal antibodies development, characterization and formulation, and their effective integration with relevant regulatory/GMP requirements.

• Ability to collaborate effectively, across functional boundaries, to align stakeholders and sponsors on technical strategies.

• Proficiency with pharmaceutical industry technical business processes: change control, deviation management, technical protocols/reports, and regulatory license documents.

What we offer

We welcome you to a truly global, dynamic, and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary

• 35,5 days of leave.

• Incentive Plan.

• Numerous training, coaching, and e-learning modules for long-term job opportunities and development.

If you have questions regarding this opportunity?

Please send your question including vacancy title and number to: RecruitmentNL@MSD.com

Only applications via the career portal will be considered.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID: R277820