CMC Process Development Manager

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.

With global operations spanning more than 100 countries, we serve patients and clinicians by ensuring our 70+ life-saving medicines reach those who need them — with urgency and reliability. Beyond hospitals, SERB supports first responders, public health agencies, and defiance organisations through its broad portfolio of antidotes and deep expertise in emergency preparedness and stockpiles. 

Having the right culture is as important to us as having the right portfolio. We are guided by our three core values:

Our growth is driven by selective acquisitions and geographic expansion, powered by teams who go the extra mile to keep critical medicines available worldwide. 

Broad Function

Responsible for the management of CMC process development of biological manufacturing processes to support new and existing biological products. 

Principle Responsibilities
1.    Lead process development activities for therapeutic antibodies.
2.    Manage team of scientists in development and small-scale manufacturing.
3.    Develop innovative manufacturing solutions for new and existing biological products.
4.    Maintain good LCM of the current approved products
5.    Perform process characterizations studies (e.g. viral and impurity clearance studies, chromatography resin reuse, process limit evaluations).
6.    Support the scale up and transfer of manufacturing processes from CMC to GMP production.
7.    Provide specialized technical CMC input to project teams and support the Operations group on with significant manufacturing investigations and CAPAs 
8.    Compile and/or assist Regulatory in compilation of CMC sections of all regulatory filings.  Provide expert advice with agency interactions, as required. Support setting of CMC budgets and ensure adherence to this budget throughout the financial year.
9.    Provide due diligence support for in- and out-licensing products as required.
10.    Ensure projects are delivered on time, in-line with all relevant guidelines, to budget, and in line with business needs.
11.    Complete additional tasks considered necessary to meet business and customer requirements as indicated by the Line Manager.
12.    To adhere to SERB’s polices on health, safety and workplace policies.
13.    Ensuring 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.
14.    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
•    Bachelor’s Degree with a sound technical background or relevant equivalent experience.
•    5Years+ experience in pharmaceutical biologics development and manufacturing, with experience in antibody manufacture desirable
•    Experience of managing vendors desirable.
•    Excellent understanding and hands–on working knowledge of chromatography, cGMP, quality and regulatory requirements for clinical and commercial manufacturing.
•    Demonstrated ability to successfully manage outsourced manufacturing and analytical contractors.

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.