ASSOCIATE CMC MANAGER (12 MONTH FIXED TERM)

F-star

Closing Date: 28/01/2022

ASSOCIATE CMC MANAGER (12 MONTH FIXED TERM)

A BIT ABOUT US…

At F-star, we are dedicated to developing next generation immunotherapies to transform the lives of patients with cancer. We develop mAb², a novel class of disruptive bispecific antibody-based therapies that have the potential to overcome tumor resistance and restore anti-cancer immunity and responsiveness.

We are committed to delivering life-changing treatments for the estimated 80% of patients with cancer who currently fail to have a durable response to immunotherapies.

Our wholly owned pipeline shows focused and potent immune activation, with a promising safety profile to date.

We’re an agile, international team with dual headquarters in Cambridge, UK and Cambridge, Massachusetts. We empower our teams to decide where and when they work to deliver our goals.

YOUR ROLE IN OUR TEAM:

We’re looking for an Associate CMC Manager to join in a unique role applying knowledge of analytical techniques and understanding of cGMP into management of the stability data for portfolio of programmes in clinical development. This position sits within our CMC department based in Cambridge, UK and will review and perform trending of externally generated stability data to ensure that the data was evaluated appropriately as per ICH guidelines. This is a 12-month, fixed term position covering a period of maternity leave.

YOUR KEY RESPONSIBILITIES WILL INCLUDE:

• Perform data review, trending and statistical analysis for ongoing stability studies

• Coordinate external testing and reporting with vendors

• Write internal protocols and reports for stability studies compliant with ICH guidelines

• Review technical documents, certificate of analysis, analytical test record, stability data tables and reports

• Coordinate logistics of receipt and storage of stability samples

A BIT ABOUT YOU:

You are highly organised with strong attention to detail and an aptitude to keep good records. You are able to work effectively across our matrix via excellent communication and collaboration skills. You have the confidence to deliver work with limited supervision by being a self-starter and meeting deadlines and working under pressure in a fast-paced environment won’t phase you.

YOUR SKILLS, KNOWLEDGE AND EXPERIENCE:

Essential:

• BSc degree or equivalent in the Life Sciences or Chemistry with a substantial and relevant analytical lab industry experience

• Proficient with data and statistical analysis software such as MS Excel, GraphPad Prism or SAS JMP

• Strong understanding of principles of statistical data analysis

• Knowledge and understanding of GMP and compendial test requirements

Desirable:

• Experience and knowledge of the operating principles of chromatography based analytical methods

• Working experience in structured assay design, record keeping and understanding of assay robustness and data quality

• Previous relevant industry experience in a regulated environment (GLP, GMP)

WHAT WE CAN OFFER TO YOU:

We get things done, we keep things simple, and we’re driven by the science. We’re ambitious so we work hard to create an environment where we can take smart risks. We want to be innovative so encourage debate and collaboration to challenge the usual way of doing things. We love our celebrations, socialising and perks, which make F-star a fun and diverse place to work. And most of all, everyone has the opportunity to make a difference.

Benefits:

• Pension (8% Employer contribution)

• Private Medical Insurance and Health Cash Plan

• Life assurance

• 25 days paid holiday, plus the option to buy 5 days

• Travel insurance

• Enhanced Maternity, Paternity, Adoption pay

• Agile working opportunities

OTHER DETAILS:

This role is to be based in Cambridge, UK and is a full-time position working 37.5 hours per week.

F-star is proud to fully embrace agile working which gives you options in how, where and when you get your work done, including flexible working hours and home working.

This is a 12-month, fixed term position covering a period of maternity leave.

NEXT STEPS…

If you feel this role is right for you, we’d love to hear from you.

To apply, please visit our website: https://www.f-star.com/about/careers/ and upload your CV for us to view. Those that shine brightest will be contacted to discuss the role further, however, we aim to get back to everyone with a response either way.

We may choose to close the role sooner than the application closing date depending on volume of candidates and so we encourage early applications.

If, along the way, you experience any difficulties with applying via our website, please email HR@f-star.com.

We aspire to be a diverse and inclusive workplace and strongly encourage suitably qualified applicants from a wide range of backgrounds to apply.

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