Principal Scientist- DMPK
EMD Serono

A career with EMD Serono is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role:

New Biological Entities Drug Metabolism and Pharmacokinetics (NBE DMPK) is seeking a highly qualified Principal Scientist with a strong background in quantitative bioanalytical development and specific expertise in developing bioanalytical methods to support large molecule biotherapeutics. The successful candidate will provide scientific support by developing (hands-on) innovative and high-quality bioanalytical methods to measure pharmacokinetics (PK), immunogenicity (binding ADA and neutralizing Ab) and biodistribution studies as it relates to non-clinical and clinical development of biologics and cell/nucleic acid-based therapeutics. The candidate will provide scientific oversight of assay development and assay troubleshooting activities at internal labs and external vendors, and actively identify/develop new analytical technologies/platforms to meet potentially challenging needs of projects. The incumbent will maintain knowledge of current industry and regulatory guidance for bioanalytical measurements and grow to be the point of contact for assays as it relates to regulatory compliance. Excellent communication and interpersonal skills, scientific thinking and problem-solving skills are required. The incumbent is expected to contribute to departmental internal and external scientific outreach activities.

The role also provides the opportunity to grow into NBE DMPK lead role that involves scientific management of the overall DMPK contributions to NBE projects, from lead optimization through Life Cycle Management (LCM).

Who You Are:

Minimum Qualifications:

• PhD in a biological or related discipline e.g. Biology, Biochemistry, Biotechnology or Pharmaceutical Science with 6-10 years' industry experience or MS with 10-15 years of industry experience in a bioanalytical role
• Extensive knowledge and hands-on experience in bioanalytical method development using different platforms (i.e., LBA, ELISA, MSD, Cell-based and enzymatic immunoassays, etc.) is required

Preferred Qualifications:

• Extensive experience in design and development of cell-based neutralizing Ab assays is preferred
• Expertise in the development of bioanalytical methods (e.g. cell-based methods (ELISpot, neutralizing Ab, cellular transduction assays) & Molecular methods (qPCR, ddPCR, RT-qPCR)) to assess PK & immunogenicity of cell/nucleic acid-based therapeutics is desirable
• Strong knowledge of industry and regulatory standards for quantitative measurements supporting PK/PD, immunogenicity, biodistribution, and biomarker studies
• Utilizes high level of technical expertise and sound judgment for troubleshooting complex technical problems and finding appropriate solutions
• Experience working with CROs on techtransfer
• General knowledge of disease areas (e.g. Immunology, Oncology, Immuno-oncology etc.) is a plus
• A collaborative, highly motivated, self-starter with excellent written and verbal communication skills, and problem-solving disposition; delivers with a sense of urgency while maintaining the highest of scientific and ethical standards
• Ensures compliance and contributes to preparation of EMD Serono technical and operational documents (SOPs and best practices)
• Mentors junior team members as appropriate
• Prepares, reviews, and delivers scientific presentations for internal/ external audiences and author related manuscripts
• Represent EMD Serono in ICH, AAPS and other national and international expert working groups on bioanalytical methods to influence industry best practices and regulatory expectations

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information athttps://jobs.vibrantm.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Job Requisition ID: 220037

Location: Billerica

Career Level: D - Professional (4-9 years)

Working time model: full-time

This job has expired.