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!
The Role
Do you want to join our highly talented Process Development team within MSAT CMC Operations and work closely with late-stage development activities in a stimulating international environment?
With Genmab's continued growth, we work with strong engagement to support late-stage development activities across portfolio projects and prepare high-quality CMC packages for regulatory filings. We are now looking for a Senior CMC Specialist, Drug Linker Development, to join our journey and contribute with strong process chemistry and API manufacturing expertise. You will be part of Process Development in MSAT. Process Development is responsible for Upstream, Downstream, and Drug Linker processes. The function currently consists of 16 people and is expanding. You will report to the Director, Head of Process Development.
Do you want to work as a team, share knowledge, be curious, ask questions, and learn new things to achieve goals and meet ambitious deadlines? You will be rewarded by focusing on teamwork and creating strong results through and with your team.
In this role, you will:
- Contribute to a pioneering company with an innovative and expansive growth strategy.
- Make a difference in people's lives through future cancer treatments.
- Leverage your expertise in organic chemistry and synthetic API manufacturing to contribute to antibody-drug conjugate, ADC, development.
- Help define strategies for payload linker and drug linker processes across late-stage CMC projects.
The ChallengeAs the Senior Drug Linker Subject Matter Expert, SME, you will be responsible for activities related to chemical intermediates, payload linkers, and drug linkers used in ADC development at Genmab's partnered CMOs. You will work across project teams to support the CMC Project Managers and collaborate closely with other SMEs in areas such as downstream processing, analytical methods, characterization, quality, and regulatory CMC.
With strong drive and engagement, you will join Genmab's growth journey and contribute with your experience and knowledge within organic chemistry, synthetic API manufacturing, and late-stage CMC development.
Key Responsibilities:- Develop and implement late-stage development strategies for chemical intermediates, payload linkers, and drug linkers.
- Define the scope for late-stage drug linker development activities in collaboration with CMOs and partners, in line with current industry standards and regulatory guidance.
- Oversee development and manufacturing activities performed at partnered CMOs, including troubleshooting, process characterization, process validation and process performance qualification.
- Contribute to the definition of starting materials, specified impurities, reference standards, specifications for intermediates and final API.
- Support evaluation of process performance, process parameters, deviations, change controls, manufacturing trends and process robustness.
- Prepare and review technical documentation, including development reports, technology transfer reports, process characterization reports, process validation documentation, batch records and SOPs.
- Author and review CMC regulatory submission documents and responses to health authority questions.
- Cross collaborate with CMC colleagues to implement ADC development strategies and control.
- Support the definition, implementation and continuous improvement of internal processes related to drug linker activities.
- Contribute to continuous improvement of CMC strategies, ways of working and collaboration with external partners
Requirements: The ideal candidate holds a degree in Chemistry, Organic Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or another relevant field, and has at least
6 years of documented professional experience within synthetic API manufacturing, process chemistry, drug linker development, or a related CMC area.
Experience from late-stage development, process characterization, process validation, regulatory CMC activities, or external manufacturing support is preferred.
Furthermore the successful candidate will have the following profile:- Strong experience in synthetic organic chemistry and synthetic API manufacturing processes.
- Experience with drug linker, payload linker, chemical intermediate or ADC-related development is preferred.
- Understanding of bioconjugation techniques is preferred.
- Thorough understanding of late-stage CMC development activities, including process characterization, risk assessment, process validation, and process performance qualification.
- Experience with definition of starting materials, specified impurities, reference standards, intermediate specifications, and final API specifications.
- Experience preparing and reviewing technical documentation, including development reports, technology transfer reports, process characterization reports, batch records, and regulatory documentation.
- Experience designing, evaluating and documenting DoE studies is preferred.
- Experience preparing and reviewing relevant filing documentation for regulatory market authorizations is preferred.
- Experience working with CMOs and external partners is preferred.
- Ability to independently drive drug linker CMC activities, provide expert input to project teams and represent drug linker development in cross-functional discussions.
- Strong communication skills, with excellence in English, both written and verbal
Moreover, you meet the following personal requirements:- You are focused on achieving goals that are important for the team and the organization.
- You have a proactive and strategic mindset with a desire to continuously develop and find strong solutions.
- You are well organized and able to plan, execute and meet deadlines.
- You have the ability to work successfully in a fast-paced environment with tight timelines.
- You are open-minded, dedicated, and flexible, with a can-do attitude and the ability to proactively handle various tasks.
- You enjoy working across functions, sharing knowledge, asking questions and contributing to solutions through collaboration.
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 forward new ideas, discuss concerns, and share feedback with colleagues and management. Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance.
Please note that applications are reviewed and interviews are conducted on an ongoing basis.
About You- You are genuinely passionate about our purpose
- You bring precision and excellence to all that you do
- You believe in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
- You take pride in enabling the best work of others on the team
- You can grapple with the unknown and be innovative
- You 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
LinkedIn and
X.
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Required Skills
Strong experience in synthetic organic chemistry and synthetic API manufacturing processes.Experience with drug linker, payload linker, chemical intermediate or ADC-related development is preferred.Understanding of bioconjugation techniques is preferred.Thorough understanding of late-stage CMC development activities, including process characterization, risk assessment, process validation, and process performance qualification.Experience with definition of starting materials, specified impurities, reference standards, intermediate specifications, and final API specifications.Experience preparing and reviewing technical documentation, including development reports, technology transfer reports, process characterization reports, batch records, and regulatory documentation.Experience designing, evaluating and documenting DoE studies is preferred.Experience preparing and reviewing relevant filing documentation for regulatory market authorizations is preferred.Experience working with CMOs and external partners is preferred.Ability to independently drive drug linker CMC activities, provide expert input to project teams and represent drug linker development in cross-functional discussions.Strong communication skills, with excellence in English, both written and verbalYou are focused on achieving goals that are important for the team and the organization.You have a proactive and strategic mindset with a desire to continuously develop and find strong solutions.
Responsibilities
- Develop and implement late-stage development strategies for chemical intermediates, payload linkers, and drug linkers.
- Define the scope for late-stage drug linker development activities in collaboration with CMOs and partners, in line with current industry standards and regulatory guidance.
- Oversee development and manufacturing activities performed at partnered CMOs, including troubleshooting, process characterization, process validation and process performance qualification.
- Contribute to the definition of starting materials, specified impurities, reference standards, specifications for intermediates and final API.
- Support evaluation of process performance, process parameters, deviations, change controls, manufacturing trends and process robustness.
- Prepare and review technical documentation, including development reports, technology transfer reports, process characterization reports, process validation documentation, batch records and SOPs.
- Author and review CMC regulatory submission documents and responses to health authority questions.
- Cross collaborate with CMC colleagues to implement ADC development strategies and control.
- Support the definition, implementation and continuous improvement of internal processes related to drug linker activities.
- Contribute to continuous improvement of CMC strategies, ways of working and collaboration with external partners
- Strong experience in synthetic organic chemistry and synthetic API manufacturing processes.
- Experience with drug linker, payload linker, chemical intermediate or ADC-related development is preferred.
- Understanding of bioconjugation techniques is preferred.
- Thorough understanding of late-stage CMC development activities, including process characterization, risk assessment, process validation, and process performance qualification.
- Experience with definition of starting materials, specified impurities, reference standards, intermediate specifications, and final API specifications.
- Experience preparing and reviewing technical documentation, including development reports, technology transfer reports, process characterization reports, batch records, and regulatory documentation.
- Experience designing, evaluating and documenting DoE studies is preferred.
- Experience preparing and reviewing relevant filing documentation for regulatory market authorizations is preferred.
- Experience working with CMOs and external partners is preferred.
- Ability to independently drive drug linker CMC activities, provide expert input to project teams and represent drug linker development in cross-functional discussions.
