Senior CMC Specialist, Drug Linker

Job title:

Senior CMC Specialist, Drug Linker

Company:

Genmab

Job description

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.Does this inspire you and feel like a fit? Then we would love to have you join us!(Senior) CMC Specialist (organic chemistry) for ADC development
Do you want to work as “One-team”?

• Pioneering company with innovative and expansive growth strategy
• Making a difference in people’s lives with future cancer treatments
• Leveraging your expertise in organic chemistry to contribute to the field of antibody-drug conjugates.
• Define the strategies around payload linkers process

The Role and DepartmentAs (Senior) CMC Specialist, Drug Linker you will join the experienced Late-Stage Manufacturing Development (LSMD) department, working on late-phase development activities for portfolio projects and preparing CMC packages for regulatory filings in a dynamic international environment. .As the (Senior) Subject Matter Expert (SME) for drug linkers, you will be responsible for overseeing activities related to the chemical intermediates used in ADC development at Genmab’s partnered CMOs. You will work across project teams to support the CMC Project Manager and collaborate closely with other SMEs in areas such as downstream processing, analytical methods, and characterization. With great energy, you will join Genmab’s growth journey, contributing your experience and knowledge in chemical manufacturing.By joining LSMD, you will be part of the Process team, which is responsible for Upstream, Downstream, and Drug Linker manufacturing processes. The team currently consists of 11 people and is in a phase of active growth. You will report to Ass. Director, Process Team Lead, CMCResponsibilities:

• Develop and implement late-stage development strategies for chemical intermediates (payload linkers).
• Define the scope for late-stage drug linker development activities in collaboration with our CMOs and partners, adhering to the latest industry standards and regulatory guidance.
• Oversee development and manufacturing activities performed at partnered CMOs, including troubleshooting, process characterization, and process performance qualification.
• Contribute to the definition of starting materials, specified impurities, specifications for intermediates and final API
• Prepare and review technical documents including development, tech transfer, and process characterization reports, as well as batch records.
• Author and review CMC regulatory submission documents.
• Collaborate with downstream SMEs to develop and align late-stage ADC development strategies.
• Support the definition and refinement of required processes for drug linker activities.

At Genmab we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary, and cross-cultural working environment characterized by strong teamwork, room for individual performance and development.Genmab is a growing organization, and you will be encouraged and welcomed to bring forth new ideas, discuss concerns and share feed-back with colleagues and management. Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance.Requirement

• The ideal candidate holds a degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or another relevant field,
• At least 3+ years of experience in the synthetic API manufacturing processes in CMC area, preferably from Late-Stage Development.
• Extensive experience in synthetic organic chemistry and preferable bioconjugation techniques.
• Thorough understanding and overview of synthetic API manufacturing processes with in-depth knowledge of process characterization, risk assessment, and late-stage validation activities
• Experience with definition of starting materials, impurities, reference standards (for API and impurities),
• Experience designing and evaluating DoE experiments is preferred.
• Experience in preparing and reviewing relevant filing documentation for regulatory market authorizations is preferred.
• Focused on achieving goals important to the team and the organization.
• Proactive and strategic mindset with a desire to continuously develop and find innovative solutions.
• Well-organized, with the ability to plan, execute, and meet deadlines.
• Ability to work successfully under pressure in a fast-paced environment with tight timelines.
• Open-minded, dedicated, and flexible, utilizing high energy and a can-do attitude to proactively handle various tasks.
• Strong communication skills, with excellence in English, both written and verbal.

You are focused on achieving goals that are important for the team and the organization. You have a proactive mindset and a desire to continuously develop and find innovative solutions. In addition, you are well-organized, and can plan, execute, and meet deadlines. You have the ability to work successfully under pressure in a fast-paced environment and with tight timelines.The deadline for applying is the 25th of April, but we will be reviewing applications and conducting interviews on an ongoing basis”About YouYou are genuinely passionate about our purposeYou bring precision and excellence to all that you doYou believe in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with a broad spectrum of backgroundsYou take pride in enabling the best work of others on the teamYou can grapple with the unknown and be innovativeYou have experience working in a fast-growing, dynamic company (or a strong desire to)You work hard and are not afraid to have a little fun while you do so!LocationsGenmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.About GenmabGenmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on and .Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website .

Expected salary

Location

København

Job date

Tue, 15 Apr 2025 22:05:40 GMT

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