Senior CMC Specialist, Upstream Processing, Genmab / 1849
At Genmab they are committed to building extra(not)ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From their employees who are caring, candid, and impact driven to Genmab’s business, which is innovative and rooted in sciences, they believe that being proudly unique, determined to be their best, and authentic is essential to fulfilling their purpose. Genmab employes 2200 dedicated and engaged people globally, and 500 headquartered in excellent surroundings in Copenhagen.
You will be part of the experienced Late-Stage Development (LSMD) team working with late phase development activities of portfolio projects and preparation of the CMC package for regulatory filings in a stimulating international environment. You will join the BI/DP Process team consisting of 6 people and hiring.
Do you want to work as one team? Share knowledge, be curious, ask questions and learn new things to achieve goals and work with ambitious deadlines? You will be rewarded by focusing on teamwork and making brilliant results through and with your team. If you can recognize yourself in this description, you might be the next brilliant Senior CMC Specialist, Upstream Processing to support the expanding portfolio and the continued global growth of Genmab.
Senior CMC Specialist, Upstream Processing
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
- You want to excel and is a skilled Upstream Processing Specialist
As the Senior Upstream Processing (USP) Subject Matter Expert (SME), you will be responsible for USP activities performed at Genmab’s partnered CMO´s, and work across project teams to support the CMC Project Manager. You will also work closely with other SME’s for e.g. downstream processing, analytical validation, and characterization. With great energy you will join Genmab’s growth journey and contribute with your upstream experiences.
The USP SME will be responsible for the following:
- Late-stage development USP strategies on ongoing projects
- Defining the scope for the late-stage USP development activities together with their CMO’s and partners according to latest industry standards and regulatory guidance
- Oversight of the USP activities performed at partnered CMO’s e.g. trouble shooting, process characterization and process performance qualification
- Prepare/review technical documents including development /tech transfer/process characterization reports and batch records
- Authoring and review of CMC regulatory submission documents
- Work closely with downstream processing SME’s to develop and align the late-stage development strategies
- Support defining/refining required processes for USP activities
At Genmab they 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. You will report to the Ass. Director, BI/DS Process Team Lead, Late-Stage Manufacturing Development, CMC
The ideal candidate holds a degree in Life Science, within Chemistry, Biochemistry, Pharmaceutical sciences, or another relevant fields and has at least 5+ years of experience from the Upstream CMC area, preferably from Late-Stage Development.
The successful candidate will have the following profile:
- You have a thorough understanding and overview of mammalian upstream processes together with an in-depth knowledge of upstream process characterization, risk assessment and late-stage validation activities
- It is preferred that you have experience designing and evaluating DoE experiments
- It is preferred that you have experience in preparing and reviewing relevant filing documentation for regulatory market authorizations
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.
As an open-minded dedicated and flexible person, you utilise your high level of energy and can-do attitude to proactively handle the various tasks at hand.
Strong communication skills are essential in this role, which interacts with other disciplines, and you are of course excellent in English, both written and verbal.
Best Talent is responsible for the recruitment process for this position at Genmab and reviews your application on a confidential basis. Forward your application including your CV attention ”1849/Sr.CMC Specialist ” by way of e-mail to email@example.com You can read more about Best Talent at www.besttalent.dk.