Scientist/Senior Scientist, Process Development

Job Title: Scientist/Senior Scientist, Process Development

Job Location: Great Britain, United Kingdom

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Mid-Senior level

Job Requisition ID: 32443

Department: R&D

Category: R&D

Location: UK Field

Date: 14 Jan 2025

Come and Save Lives with Us!

SERB Pharmaceuticals is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. We have over 470 employees in 16 countries and a group revenue in excess of €350m.

Our portfolio of 80+ rescue medicines makes a real difference in the lives of patients and their caregivers and that gives every one of our employees a sense of purpose.

Our Purpose Is Supported By Our 4 Key Values

• We make patients our priority
• We act with integrity and accountability
• We work together as one team
• We look for better ways forward

Scientist/Senior Scientist, Process Development

Reports To: Manager, CMC

Department: R&D CMC

Location: Remote/Hybrid (Wales site)

Date Reviewed: December 2024

Broad Function:

To support process improvements across multiple projects within the CMC team for the development and lifecycle activities of new and existing commercial activities, with a focus on upstream process development. This role provides an exciting opportunity to join an established team that supports clinical and commercial manufacture of biologically derived products at both external CDMOs and in-house manufacturing sites. This is a remote role or hybrid role that would be partially based at the Wales site.

Principal Responsibilities:

• Support manufacturing studies at external parties to develop manufacturing cost of goods, lifecycle management and process improvement opportunities for biologically derived products.
• Experience in developing E.coli derived proteins using processes such as fermentation, centrifugation, depth filtration, microfiltration by tangential flow filtration is desirable.
• Support the development and validation of process improvements for manufacturing and commercial activities of new and established biological products.
• Knowledge of upstream and downstream manufacturing processes, development and scale-up for biologically manufactured products is desirable.
• Act as scientific interface between SERB and third parties for technical discussions surrounding process development/improvements of established manufacturing processes.
• Assist in the compilation and review of data and information for the preparation of reports generated by third parties.
• Maintain all relevant documentation accurately, correctly and up to date.
• Initiate and write quality documents such as standard operating procedures, protocols and reports as and when required.
• Follow health and safety guidelines as issued by the company.
• 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 Company 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.

Principal Relationships:

• Accountable to:
• Internal:

CMC Manager

Liaise with internal personnel at all levels of the business as required.

• External:

Liaise with external 3rd parties as required.

Education and Experience:

• Educated to degree level in appropriate scientific discipline.
• 1-3 years’ experience in upstream process development, such as bacterial fermentation and clarification techniques, in a biopharmaceutical or closely related industry and awareness of regulatory requirements (desirable but not essential).
• Computer literate with software such as Microsoft Office 365.
• Experience with data analysis software programs (e.g Minitab).

Skills and Attributes:

• Competent and organised with ability to perform multiple tasks concurrently.
• Strong ability to undertake continuous learning of scientific techniques and industry expectations.
• Track, manage and minute project milestones and communicate to the project team.
• Ability to work closely with others, display good team spirit and demonstrate initiative when required.
• A dynamic, flexible and willing attitude with the desire to continually improve and develop.
• Strong communication skills with the ability to follow instructions and guidance.
• Methodical, organised with an aptitude for detail.
• Able to take responsibility when required.

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.

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