CMC Manager (FTC 15 months)

Critical Needs. Immediate Action. SERB is a fast-growing global specialty pharma company designed to address rare and urgent conditions by delivering life-saving medicines when time and complexity leave no room for failure. We operate end-to-end across 100+ countries, ensuring 70+ essential medicines for rare diseases, emergency care, and medical countermeasures reach patients and clinicians with urgency – wherever and whenever they are needed.

Shaped over the past 25 years by an entrepreneurial, disruptive spirit, SERB combines the focus and agility of a biotech with the scale, reach, and reliability of a global pharmaceutical company — always grounded in medical purpose, not corporate convention. Our 600+ employees are driven by three core values:

• Patients first, always: Patients are not a concept — they are why we act, especially when time matters most.
• Impact focused: We are agile, entrepreneurial, and disciplined - working smart and learning continuously to deliver results that matter, with the consistency, quality, and trust that critical care demands.
• Team powered: We go the extra mile - together - because our shared commitment drives extraordinary outcomes.

Guided by a clear ambition and a relentless focus on patients, SERB continues to expand through selective, innovative acquisitions, launching new treatments and entering new geographies. Across every step — from integration to delivery — our people act with passion, ownership, and determination to ensure life-saving medicines become available to patients who need them, worldwide.

Broad Function: Responsible for the management of CMC development and commercial activities for SERB Pharmaceuticals. The role provides an exciting opportunity to manage technical CMC and process development studies in support of biological products across clinical and commercial manufacture at both CDMOs and in-house manufacturing sites.

Principal Responsibilities:

• Manage CMC studies in support of BLA, MAA preparation.
• Provide technical expertise to manufacturing activities for SERB products at CDMOs.
• Identify phase-appropriate studies and lead internal/outsourced activities to ensure studies are performed.
• Strong knowledge of upstream and downstream manufacturing processes, development, and validation for biologically manufactured products.
• Experience in therapeutic antibodies manufacture desirable.
• Compile and/or assist Regulatory in compilation of CMC sections of Module 3 BLA/MAA chapters.
• Support setting of CMC budgets and ensure adherence to this budget throughout the financial year.
• Provide due diligence support for in- and out-licensing products as required.
• Adhere to SERB’s policies on health, safety and workplace policies.
• Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with SERB values.
• Carry out other reasonable tasks as required by the Line Manager.

The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

Education and Experience:

• Bachelors Degree with a sound technical background.
• Excellent understanding and hands–on working knowledge of process development, manufacturing and CMC of biologics.
• Demonstrated ability to successfully manage outsourced manufacturing CDMO.

Skills and Attributes:

• Strong technical background with an excellent working knowledge of manufacturing of biologics.
• Demonstrated ability to successfully manage CMO’s.
• Demonstrated negotiation and influencing skills.
• Strong leadership and influencing skills.
• Excellent communication skills and the ability to interact cross-functionally.
• Ability to understand and analyse complex data and to identify critical issues; ability to identify and implement corrective actions.
• A keen strategic thinker who is willing to apply new concepts and ideas to take the business forward.

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.