DSP Scientist

Johnson & Johnson; Leiden; Hybrid; EUR 55,000 - 96,000; Full time

Benefits offered by this job

Hybrid work (home & on-site)

Job summary

Johnson & Johnson Innovative Medicine in Leiden is recruiting a DSP Scientist in Therapeutics Development and Supply (TDS) API to lead purification process development, scale-up and tech transfer for large molecule therapeutics.

You will design experiments, generate dPFDs and batch records, author regulatory sections, and collaborate across global teams in a hybrid work setting that blends remote and on-site activity.

Qualifications

• Demonstrated scientific ability in process development, process validation and/or technology transfer.
• Detailed technical knowledge of biopharmaceutical manufacturing site unit operations.
• Excellent interpersonal skills; ability to work in international and dynamic environments.

Responsibilities

• Operates at a high level of autonomy; develops purification processes and supports scale purification and in-process characterization.
• Leads purification process development, qualification, validation, and technology transfer activities.
• Delivers Technology Transfer reports, dPFDs, batch records, and scientific manuscripts.
• Authors/reviews sections of regulatory submissions including INDs and BLAs.
• Proposes creative solutions using data analysis and statistical tools.
• Works in team settings and independently to meet timelines; aligns with GMP and EHSS requirements.

Skills

Process development

Technology transfer

Regulatory submissions

Education

PhD (0-3 years Pharma/Biotech)

M.Sc in Biotechnology/Bioprocess Eng/ Biochemistry

Job description

Johnson & Johnson Innovative Medicine is recruiting for a DSP Scientist in Therapeutics Development and Supply (TDS) API, located in Leiden.

TDS API is part of the global Discovery, Product Development and Supply organization. The department drives the development of our industry-leading pipeline and maintains scientific ownership for product development.

Your theoretical foundation in process technology and antibody purification will be brought into practice by supporting purification process development activities; leading validation studies, scale up and tech transfer activities and authoring technical reports and regulatory filings. The role is responsible in the execution of timely and effective purification experiments for large molecule therapeutic proteins. The Scientist will work in an environment that values innovation, leadership, scientific excellence, diligence and personal accountability.

roles and responsibilities

• Operates at a high level of autonomy, independently develops stages of purification processes and supports all aspects of laboratory or manufacturing scale purification and associated in-process characterization.
• Leads purification process development, qualification, validation, and technology transfer activities.
• Delivers Technology Transfer reports, detailed Process Flow Diagrams (dPFD), batch records, and scientific manuscripts.
• Authors and reviews sections of regulatory submissions including INDs and BLAs
• Proposes creative and effective solutions to stablish design spaces based on analysis of complex data and use of statistical tools.
• Proactively investigates, proposes, and develops improvements to existing processes or new processes.
• Makes a positive contribution to the organization, seeks opportunities for improvement across projects
• Works in team environment as well as individually to meet project timelines and objectives. Connects with a wide range of counterparts.
• Aligns with GMP, regulatory, training, and EHSS requirements

how to succeed

Qualifications

Education:

• PhD (or equivalent) with 0-3 years of Pharma/biotech industry/Postdoc experience.

M.Sc (or equivalent) in Biotechnology, Bioprocess Engineering, Biochemistry or other relevant Life Sciences or Engineering field with some years of experience

Required:

• Demonstrated scientific ability in process development, process validation and/or technology transfer.
• Detailed technical knowledge of biopharmaceutical manufacturing site unit operations.
• Excellent interpersonal skills.Ability to successfully interact and operate in an international and dynamic environment
• Analytical and entrepreneurial thinker, adaptable and flexible with good problem solving skills. Results driven, with focus on customer satisfaction and timely delivery of high-quality output.

Preferred:

• Learning agility and ability to work across multiple projects highly preferred.
• Experience developing collaborative relationships with (Leiden) Supply Chain and (Cork/Malvern) R&D community.
• Ability to present scientific content to diverse audiences.
• Strong leadership qualities.

Other:

• Proficient in English, Dutch is a bonus
• Experience with Project Management, Process validation, Process improvements and Commercial manufacturing support are a plus.
• J&J flex position: hybrid working from home and on-site

This role offers a very competitive hourly rate. This contract will run for a 12 month duration.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

application process

We are looking to process the first round of applications within the next 2 working days.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.