Senior Specialist, CMC Drug Product
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Job Location:
Copenhagen - Denmark
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
At Genmab we are dedicated to building extranotordinary 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 work as one 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 achieving outstanding results through and with your team.
You will be part of Manufacturing Science & Technology (MSAT) within CMC Development & Manufacturing contributing to late-stage development activities across portfolio projects and preparing CMC documentation for regulatory filings in a stimulating international environment.
If you recognize yourself in this description you might be the right choice as our(Senior) Specialist CMC Drug Product we arelooking to hire to support Genmabs expanding portfolio and continued global growth.
The position is placed in the CMC Pharmaceutical Development. CMC Pharmaceutical Development is part of MSAT and is responsible for Drug Productlate-stagedevelopment validation and manufacturingactivities as well as Life-Cycle management activities. The department currently consists of 7 people and is expanding. You will report to the Head of CMC Pharmaceutical Development.
Responsibilities
With great energy you will join Genmabs growth journey and contribute with your drug product and/or Life Cycle Management experiences. As a (Senior) Drug Product subject matter expert (SME) you will be responsible for the following:
Drug Product (DP) activities performed at Genmabs partnered CMOs and work across project teams to support the CMC Project.
Overseeing DP activities incl manufacturing campaigns performed at partnered CMOs including troubleshooting process characterization tech transfer and process performance qualification.
Support drug product batch manufacturing by review of protocols master batch records and executed batch records thereby supporting release of clinical and commercial batches for one or more of our late-stage projects.
The right candidate will potentially also be assigned responsibilities within DPlate stagedevelopment activities -use compatibility studies and line extension activities for drug product (potentially new formulations or other changes).
Authoring and reviewing CMC regulatory submission documents.
Supporting the definition and refinement of required processes for late-stage / LCM DP activities.
You will work closely with other SMEs and project managers -stage drug product development as well as our commercial supply chain colleagues regulatoryaffairsand QA.
Requirements
Masters degree in science pharmacy or a related technical area.
7 years of experience in CMC or related area in pharmaceutical biotechnology and/or medical device industry preferable within life-cycle management of product or commercial manufacturing.
Experience with late-stage development and commercialization of biologic drug products.
Thorough understanding and overview of aseptic drug product processes experience from manufacturing and/or development of biological drug products (liquid and/or freeze-dried drug products) with in-depth knowledge of risk assessment and late-stage validation activities.
Experience with regulatory documentation including regulatory commitments experience with quality documentation according to Good Manufacturing Practice.
Ability to write and review documentation for regulatory market authorizations (e.g. BLA MAA)and clinical trial applications.
Excellent communication skills in English (both written and oral) and the ability to work in multicultural teams.
Ensure compliance with applicable regulatory guidelines and industry standards.
Travel can be expected.
Goal-oriented with a focus on achieving outcomes important to the team and organization.
Proactive taking initiative and responsibility in a fast-paced environment.
Youhave the ability towork successfully under pressure with tight timelines.
Team player capable of collaborating with a diverse group of internal and external stakeholders.
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!
Locations
Genmab 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 youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.
About Genmab
Genmab 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 Genmabs 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 and follow us on LinkedIn and X.
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Required Experience:
Senior IC
Key Skills
About Company
Founded in 1999, we are an international biotech company committed to improving the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, our passionate, innovative and collaborative team has invented next-generation antibody technology platforms ... View more
