Senior CMC Specialist, Upstream Processing, Lifecycle Management

Genmab; København; In loco; DKK 624.000 - 936.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Descrizione del lavoro

Genmab is seeking a Senior Scientist in Copenhagen to lead upstream processing activities within MSAT, collaborating with CMOs and cross-functional teams to support commercial manufacturing and lifecycle management.

The role emphasizes scientific leadership, data interpretation, and decision-making to ensure robust upstream processes and alignment with regulatory expectations.

Competenze

• MSc or PhD in Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related field.
• At least five years of experience in upstream CMC, including late-stage development and regulatory CMC activities.
• Experience with lifecycle management and commercial manufacturing support is preferred.

Mansioni

• Provide upstream scientific oversight at CMOs for lifecycle management and commercial manufacturing.
• Evaluate manufacturing performance, trends, deviations, and change controls to improve robustness.
• Collaborate across disciplines to align process strategies and recommendations.

Conoscenze

Upstream processing

CMC collaboration

Regulatory knowledge

English proficiency

Formazione

MSc/PhD in Life Sciences

Strumenti

CMC documentation tools

Descrizione del lavoro

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.

The Role and Department

We are looking for a Senior Scientist with strong expertise in upstream processing (USP) to provide scientific leadership in commercial manufacturing support and lifecycle management. You will help define and maintain upstream process strategies, evaluate commercial manufacturing performance, and guide scientific decisions in close collaboration with internal teams and external manufacturing partners.

This role offers the opportunity to combine technical depth with cross-functional influence in a fast-paced, international environment.

You will join Process Development within Manufacturing Science and Technology (MSAT), CMC Operations. The function is responsible for upstream, downstream, and drug-linker manufacturing processes and works closely with CMC Project Managers, contract manufacturing organizations (CMOs), and cross-functional experts to support commercial manufacturing, lifecycle management, and late-stage development.

Process Development currently consists of 20 colleagues and is expanding. You will report to the Associate Director, Team Lead of Upstream Development.

The position is based on-site in Copenhagen, Denmark.

Responsibilities

As a senior USP expert, you will provide scientific oversight of upstream activities at Genmab’s partnered CMOs and work across project teams to support CMC Project Managers. Your primary focus will be commercial manufacturing and lifecycle management, with additional responsibilities supporting late-stage development and the transition to commercial supply.

You combine scientific/technical rigor with sound judgement and a collaborative approach. It includes interpreting complex process data/findings and turning them into clear recommendations, building alignment among stakeholders, and guide activities that support robust manufacturing processes.

Your Responsibilities Will Include

• Providing upstream scientific expertise for lifecycle management activities, including batch review, process comparability, continued process verification, compliance-related investigations, and global post-approval changes.
• Evaluating manufacturing performance, including process trends, deviations, and change controls, risk assessments leading to recommendations for improved manufacturing robustness.
• Oversee upstream activities with CMOs and partners, ensuring alignment with commercial needs, current industry standards, and regulatory expectations.
• Assessing scientific progress and identifying/evaluating risks, knowledge gaps, and improvement opportunities.
• Authoring and reviewing CMC regulatory documentation, contributing to responses to health authority questions, and preparing scientific documentation for post-approval changes.
• Collaborating across disciplines, including downstream processing, analytical validation and characterization, Quality, Regulatory CMC, and manufacturing, to align process strategies and recommendations.
• Mentoring specialists and scientific colleagues, enjoying sharing expertise and knowledge to support the team´s scientific and technical development.

Requirements

• You hold a MSc or PhD degree in Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or another relevant life science or engineering discipline.
• You bring at least five years of relevant professional experience in upstream CMC, preferably with substantial experience in late-stage development, commercial manufacturing support, lifecycle management, and regulatory CMC activities.

You Have

• Strong expertise in mammalian upstream processing, including cell culture, bioreactor operation, process parameters, raw materials, scale-up, and process control strategies.
• A solid understanding of upstream process characterization, risk assessment, process validation, process performance qualification, and continued process verification.
• Experience with lifecycle management activities such as process optimization, comparability, process monitoring, deviation investigations, change control, and post-approval changes.
• Experience preparing or reviewing CMC documentation for regulatory submissions and marketing authorizations.
• Preferably, experience collaborating with CMOs and external partners in late-stage development or commercial manufacturing.
• Strong written and verbal communication skills in English.

The application deadline for this position is 23. October. Applications will be reviewed on an ongoing basis

The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is:

DKK624.000,00---936.000,00

The final salary offer will depend on several factors, including your skills, qualifications, and experience.

In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

Benefits

When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to:

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process.

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, 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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